Morbid Obesity Clinical Trials

Effects of RM-493 on Energy Expenditure in Obese Individuals
Background: - RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It has helped to reduce body weight and improve insulin sensitivity in lab tests. However, it is not fully known whether RM-493 [more...]  causes weight loss by just decreasing appetite or by increasing metabolism or both. Researchers want to see how RM-493 affects metabolism and hormones that affect the metabolic rate. They also want to see how RM-493 affects appetite by assessing feelings of hunger and fullness. They will study this drug in people who are obese but are otherwise in good health. Objectives: - To see how RM-493 affects metabolic rate and appetite in obese but otherwise healthy individuals. Eligibility: - Individuals between 18 and 50 years old who are obese (body mass index between 30 and 40 kg/m2) but are otherwise healthy. Design: - The study consists of three phases. The first phase is the screening visit. The second phase is an 8-day inpatient stay. The final phase is a follow-up phone call one week after the end of the second phase. - Participants will be divided into two groups. One group will receive the study drug first, followed by a placebo. The other group will receive the placebo followed by the study drug. The study drug and placebo will be given under the skin for 3 days each by a small device (OmniPod) that normally is used to give insulin to people with diabetes. - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also meet with a dietitian. The OmniPod device will be demonstrated before use. - Participants will have the following procedures during their 8-day inpatient stay: - Daily exercise routine (walking on treadmill) after setting a comfortable pace (miles per hour) during an exercise test - Wear physical activity monitors - Body composition study to measure amounts of fat and muscle - Calorie controlled study diet - Study drug/placebo dose through the OmniPod (Days 2 through 4 and 5 through 7) - Metabolic rate studies using a cart or the metabolic chamber - Daily blood samples - Urine collection for 24 hours - Questions about weight history and appetite - About a week after the inpatient stay, participants will have a followup phone call to ask about any side effects from the study.
Status: Recruiting Start Date: May 2013 Completion Date: December 2014
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Study objectives: 1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery 2. support multi-disciplinary bariatric sites in [more...]  Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.
Status: Recruiting Start Date: April 2012 Completion Date: October 2013
Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass
The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass). This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative [more...]  complication incidence. It will also provide information on direct and indirect costs of surgery.
Status: Recruiting Start Date: November 2012 Completion Date: November 2014
Pharmacokinetics of Acetaminophen in Morbidly Obese Patients
This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation
Status: Recruiting Start Date: December 2012 Completion Date: June 2014
Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients
Abstract: Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple [more...]  steatosis to steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these hepatic lesions is difficult especially as they may exist while the liver tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to the risk of hemorrhagic complications. Objectives: The main objective of the study was to determine in patients with morbid obesity waiting for bariatric surgery, the accuracy of non-invasive tests to assess liver steatosis, fibrosis and inflammation for the diagnosis of NASH, taking as reference the liver biopsy with a morphometric study of these parameters. Inclusion criteria: Patients with the following criteria will be eligible for the study: - Age ≥ 18 years - BMI ≥ 35 kg/m2 - Bariatric surgery scheduled within 3 months following the inclusion - Signature of informed consent Non-inclusion criteria: Patients with at least one of the following criteria will not be eligible for the study - Patient non-affiliated to a social security scheme (beneficiary or assignee) - Contra-indication for performing an MRI - weight>230 kg; anteroposterior diameter>40 cm - Cancer treatment or medication that may induce lesions of steatohepatitis (corticoids, methotrexate, amiodarone, perhexiline, tamoxifen, nifedipine, diltiazem, hycanthone) - Alcohol consumption >20 g per day for women and >30 g per day for men AND no past history of excessive alcohol use for more than a 2-year period within the last 20 years - Known chronic liver disease (except for steatosis): presence of HBs antigen, or antibody to HCV, or anti-nuclear antibodies, anti-mitochondria, anti-LKM1, anti-smooth muscle negative, or the presence of a hemochromatosis, - Known HIV positive status - Pregnant (known pregnancy) or lactating women Number of subjects required: According to the literature and data collected Louis Mourier in the recent years, the inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and steatohepatitis. All patients will be included in Louis Mourier hospital. Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total duration of participation for a patient will be one month. Methodology: It is a monocentric, prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The "open " MRI system allows access to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in France and liver pathology can be explored only on the system of Louis Mourier. The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP, and serum tests. Examinations required specifically for research Examinations required specifically for the research is abdominal MRI, FibroScan/ CAP and serum tests. Primary endpoint : To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of these tests are calculated. The gold standard is the result of histology on liver biopsy, with a morphometric study of these parameters. ROC curves are used to determine the best compromise between sensitivity and specificity. The secondary endpoints were: Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat, of subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal
Status: Recruiting Start Date: October 2012 Completion Date: June 2016
Laryngeal Masks for Bariatric Surgery
Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.
Status: Recruiting Start Date: July 2012 Completion Date: July 2014
Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities
Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part [more...]  of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity. The objective of this study is to investigate the effect of variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb results in more weight reduction. The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.
Status: Recruiting Start Date: July 2012 Completion Date: December 2018
Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient
Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. [more...]  Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least equally to standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid and long-term complications.
Status: Recruiting Start Date: September 2009 Completion Date: 
Laparascopic Adjustable Gastric Banding in Adolescents
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Status: Recruiting Start Date: August 2007 Completion Date: December 2018
Treatment of Low Metabolic Rate Following Bariatric Surgery
The purpose of this Research Study is to determine the effect of a combination medication, ephedrine and caffeine, on metabolic rate and weight loss after gastric bypass surgery. Approximately 40% of patients struggle with their weight loss rate, or metabolic rate, after [more...]  bariatric surgery, and at least 30% previously had or develop a low metabolic rate after surgery. Metabolic rate is the speed at which calories are burned. The fewer the calories eaten and the more calories burned, the more rapidly weight is lost. It is possible that despite a very low calorie intake following bariatric surgery metabolic rate will decrease so much so that weight does not decrease even if intake is reduced to 1000 calories per day. Ephedrine is a medicine used commonly to treat asthma, difficulty breathing, and wheezing. However, 40 years ago it was reported in scientific studies that ephedrine increases weight loss in patients on low calorie diets. The reason for this is an increase in the amount of calories that are burned while taking ephedrine. It was also found that combining caffeine with ephedrine makes ephedrine work more efficiently (more weight loss over time). There are many studies about the effect of ephedrine on weight loss that began in 1974 with patients on food diets. Ephedrine used in various strengths and with a number of different combinations has shown to be effective and safe, especially when directed by a physician. There is only one study where ephedrine has been used in patients after bariatric surgery. In that study, both the patient and medical staff knew they were taking ephedrine (i.e., they were not "blinded"). The patients who were not losing weight or had measured low metabolic rates were treated with ephedrine. The patients taking ephedrine lost more weight after surgery than those not taking ephedrine. While this is a significant finding, the study was not designed to be the best test of the effects of ephedrine. The best test is where neither the patients nor the medical staff know if the patient is taking the active drug (double blind). All patients enrolled into the Research Study will receive capsules that contain either ephedrine and caffeine (the active drug) or identical capsules with no active ingredient (called a "placebo"). Neither group of patients will know which set of capsules they receive. The expected duration of treatment in the Study is 7 months from the day of surgery. This is a single site study. All patients will have their gastric bypass performed through Oregon Weight Loss Surgery at Legacy Good Samaritan Hospital. The investigators expect to study 200 patients with 100 receiving the study drugs (ephedrine and caffeine in a capsule) and 100 receiving placebo (inactive ingredients in an identical capsule) over approximately 6 months.
Status: Recruiting Start Date: May 2012 Completion Date: April 2014
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
This study will determine how morbid obesity affects the distribution and metabolism of the drug propofol. The investigators hypothesize that propofol will be distributed and metabolized differently in morbidly obese subjects as compared to normal weight subjects.
Status: Recruiting Start Date: January 2011 Completion Date: January 2013
Factors Influencing the Positive Outcome of Bariatric Surgery for Morbidly Obese Patients
The purpose of this study is to report data with patients after bariatric surgery.
Status: Recruiting Start Date: January 2012 Completion Date: January 2014
Bariatric Surgery and Reactive Hypoglycemia
Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2 obesity associated with complications. Among the bariatric surgical procedures, roux-en-y gastric bypass (RYGB) was shown to account for 41% of all bariatric operations at least in [more...]  the United Sates. Sleeve gastrectomy (SG), that was conceived as the first step before performing a RYGB or a biliopancreatic diversion with duodenal switch in patients who were super-obese, has recently emerged as a new restrictive bariatric procedure. Reactive hypoglycemia is a late complication affecting up to 72% of RYGB patients although it seems to occur also after SG, in about 3% of the cases. However, until now no prospective studies have investigated the incidence of hypoglycemia after RYGB nor randomized studies have been undertaken to compare the effect of SG to that of RYGB in terms of incidence of hypoglycemic episodes. The primary aim of the present study is to conduct a 1-year randomized trial to compare the incidence of hypoglycemia after RYGB or SG.
Status: Recruiting Start Date: October 2012 Completion Date: December 2014
Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients
Postoperative residual curarization in the post anaesthesia unit has been associated to complications involving respiratory function and impaired laryngeal and pharyngeal muscles' function. Speed of reversal of neuromuscular blockade after administration of sugammadex versus neostigmine has been studied, but [more...]  up to date no data are available concerning continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii in morbidly obese patients undergoing weight loss surgery. The investigators' aim in this prospective, double-blinded study was to compare train of four ( TOF ) values, the presence or absence of clinical criteria of postoperative residual curarization , the dose requirements and the side effects of sugammadex and neostigmine for the reversal of rocuronium induced neuromuscular blockade in patients undergoing laparoscopic or open surgery for morbid obesity.
Status: Recruiting Start Date: January 2012 Completion Date: November 2012
Oxygenation Test During General Anesthesia
The study investigates if applying a special ventilatory strategy during anesthesia for laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates [more...]  oxygenation with blood gas samples but also with a new method that might give more information without the use of blood gas samples. Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction and maintenance of anesthesia is performed with either a continuous positive airway pressure (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in comparison to a technique without CPAP but with a PEEP of 10 cm H2O. Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative period if emergence from anesthesia is performed without high levels of oxygen.
Status: Recruiting Start Date: March 2012 Completion Date: December 2014
Accelerated Aging of the Cells of Visceral Adipose Tissue in Morbid Obese Subjects
Numerous epidemiological studies clearly showed the relationship between the excessive growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and other cardiovascular risk factors. However, the mechanisms contributing to the deleterious role of visceral [more...]  adipose tissue remain to be elucidated. Several observations suggest that adipose tissue depots exhibit distinct metabolic and secretory capacities according to their locations. We have recently shown that visceral fat depots display higher immuno-inflammatory cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and several markers related to aging. Finally, we have shown that visceral adipocyte-derived secretions promote the endothelial cell senescence in an extent higher than subcutaneous adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon related to the location and therefore the microenvironment of adipose tissue and 2) might be responsible for an abnormal activation of proinflammatory response, favouring the development of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis, based on these observations, is that the visceral adipose tissue provides a microenvironment that promotes accelerated aging. This senescence may be responsible for the establishment of an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation capacity of progenitor cells leading to the development of obesity associated diseases. The proposed project is a descriptive cross-sectional pathophysiological study .The aims are 1) to better define the process of senescence in human adipose tissue, 2) to precise the mechanisms and 3) to analyse the cellular and functional consequences of aging on inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for bariatric surgery will be studied. The collection of clinical and laboratory data and the collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells, progenitor cells and immuno-inflammatory cells). This project will permit to better understand the pathogenicity associated with the excessive growth of visceral adipose tissue and may reveal new therapeutic targets to limit obesity-associated pathologies.
Status: Recruiting Start Date: February 2012 Completion Date: January 2016
Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear. The investigators [more...]  want to compare the effects between preventing a proximal (oral) portion of the jejunum from food contact with the effects when preventing the jejunum from contact with bile and pancreatic juice. Endpoints are quality of life, gstrointestinal function, and weight development.
Status: Recruiting Start Date: June 2011 Completion Date: June 2014
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and [more...]  blood samples are taken again.
Status: Recruiting Start Date: December 2011 Completion Date: December 2014
Study of Menstrual Irregularities and Endometrial Pathology in Women Undergoing Bariatric Surgery
Objectives: Given the profound impact of obesity on the genesis of endometrial cancer, this study proposes to prospectively evaluate the baseline prevalence of menstrual irregularities and endometrial pathology in morbidly obese women and discover risk stratification markers that can [more...]  potentially identify the highest risk women who might benefit from targeted cancer prevention strategies in a future clinical trial. - Specific Aim 1: To assess the prevalence of menstrual irregularities and to correlate gynecologic and menstrual history with the perceived personal risk and severity of gynecologic cancers in a population of female bariatric surgery candidates. - Specific Aim 2: To determine the prevalence of endometrial hyperplasia and cancer in morbidly obese women undergoing bariatric surgery. - Specific Aim 3: To obtain adipose, endometrium, and blood samples (before and after) bariatric surgery to assess baseline hormone levels and adipocyte-derived factors and to correlate with presence of menstrual irregularities, endometrial hyperplasia or cancer, and with postsurgical weight changes. Methods: - Specific Aim 1: After informed consent is obtained, a survey and medical history of prospective bariatric surgery patients will be performed at the University of Virginia. - Specific Aim 2: For those women who undergo bariatric surgery, study investigators will perform endometrial biopsies at the time of bariatric surgery on participants to determine the status of the endometrial lining and the potential presence of endometrial cancer and its precursors. - Specific Aim 3: At the time of surgery, blood, adipose, and endometrial tissue samples will collected for evaluation of adipocyte-related factors and correlation with clinical endpoints. Blood will also be collected at 6 and 12 months after surgery. Anticipated results: This study will identify the prevalence and correlation of menstrual irregularities with endometrial abnormalities and cancer in morbidly obese women as well as define their perceived risk of developing cancer. Serum biomarkers in obese women with and without endometrial cancer/precancer would be evaluated for correlation and potential applicability for endometrial cancer screening in this high-risk population. Most importantly, this study may provide evidence as to whether screening (via endometrial biopsy or other serum markers) is warranted in asymptomatic, morbidly obese women and suggest potential preventive and risk reduction mechanisms.
Status: Recruiting Start Date: January 2011 Completion Date: January 2014
Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified duodenal switch. It is performed on morbid obese patients and severe T2DM patients with obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and [more...]  a remission of T2DM. A lower complication rate than for duodenal switch is expected.
Status: Recruiting Start Date: April 2007 Completion Date: April 2015
Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Medications most commonly used to control for [more...]  post-operative pain are opioid medications, whose well known adverse effects include PONV. Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief without the aforementioned risks. The primary goal for this study is to evaluate the the administration of pre- and post-operative IV acetaminophen to determine if there is in an overall decrease in the use of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective PONV leading to sooner return of bowel function, enabling progression to oral intake and decrease in post-operative length of stay.
Status: Recruiting Start Date: October 2011 Completion Date: 
Abiliti™ Treatment in Obese Subjects
The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects.
Status: Recruiting Start Date: April 2011 Completion Date: January 2015
Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial
Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight loss and [more...]  resolution of metabolic co-morbidities in morbidly obese patients . However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine whether probiotics would improve annoyed GI symptoms after gastric bypass. Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut. They are also called "friendly bacteria" or "good bacteria." Probiotics are available to consumers mainly in the form of dietary supplements and foods.
Status: Recruiting Start Date: October 2011 Completion Date: July 2012
Virtual Environments For Supporting Obesity Treatment
Participants 60 Patients seeking treatment at the Obesity Unit of the Medica Sur Hospital in México City, Mexico. Informed consent to participate will be aleatory assigned to a three different conditions. Procedures In the initial interview, prospective participants will [more...]  be provided with detailed information about the study and the treatments. All patients included in the study will be randomly assigned to the one (N=20) of the three treatment conditions described below, all conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will be administered by two chartered clinical psychologists and one chartered psychotherapist under the supervision of a senior chartered psychotherapist. The three therapists will be balanced among the three conditions. 1. Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5 weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum). 2. Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment proposed in the first condition plus 15 additional sessions over 6 weeks. Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive—behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns. In particular, after the first week the patients will enter 5 weekly group sessions aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed at establishing and maintaining weight loss, addressing barriers to weight loss, increasing activity, addressing body image concerns and supporting weight maintenance. 3. Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment proposed in the first condition plus 15 additional sessions over 4/6 weeks. In the sessions we will use the "20/20/20 rule". During the first 20 minutes, the therapist focus on getting a clear understanding of the patient's current concerns, level of general functioning, and the experiences related to food. This part of the session tends to be characterized by patients doing most of the talking, although therapist guides with questions and reflection to get a sense of the patient's current status. The second 20 minutes is devoted to the virtual reality experience. During this part of the session the patient enters the virtual environment and faces a specific critical situation (Kitchen, Supermarket, Pub, Restaurant, Gymnasium, etc.). Here the patient is helped in developing specific strategies for avoiding and/or coping with it. In the final 20 minutes the therapist explores the patient's understanding of what happened in VR and the specific reactions - emotional and behavioral - to the different situations experienced. If needed, some new strategies for coping with the VR situations are presented and discussed. To support the empowerment process, the therapists follow the Socratic style: they use a series of questions, related to the contents of the virtual environment, to help clients synthesize information and reach conclusions on their own. In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months after the treatment conclusion.
Status: Recruiting Start Date: January 2011 Completion Date: December 2013
Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using Positron Emission Tomography (PET) and MRI.
Diet and nutrition are important factors in the maintenance of good health throughout the entire life course. Their role as determinants of chronic diseases such as obesity, diabetes and cardiovascular diseases is well established. The annual increase in the prevalence and [more...]  the severity of obesity in both adults and children is currently substantial, and in Finland 40% of adults are overweight or obese. Identifying the mechanisms that make some individuals vulnerable to overeating, as well as pinpointing how obesity changes the functioning of the human mental and bodily functions would be critical for understanding the current high prevalence of obesity. Animal studies suggest that the brain extensively coordinates the adaptive mechanisms and the alterations of energy intake and expenditure. Accumulating evidence suggest that obesity is associated with changes in brain morphology and function, thus the source for obesity may lie in the brain. In the present project the investigators test this hypothesis by implementing a multimodal neuroimaging approach with positron emission tomography (PET), functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI) and voxel-based morphometry (VBM). By studying brain anatomy and function in lean individuals as well as obese patients undergoing weight loss surgery, the investigators can evaluate whether the observed differences between lean and obese individuals are causes or consequences of obesity. In PET imaging of the brain, the investigators will focus on two specific neurotransmitter systems, dopamine and opioid, which are largely been unexplored in obesity research. Obesity is related to elevated plasma glucose levels and endothelial dysfunction. Elevated plasma glucose and endothelial dysfunction are known risk factors for diabetes and coronary heart disease. Weight reduction modifies risk factors such as blood pressure and lipid profile for chronic diseases. On this study the investigators are able to further investigate changes in fatty acid metabolism and hormones affecting feeding and energy balance. In addition, changes in brain activation in response to food stimuli will be assessed. As far as the investigators know there are no previous positron emission tomography (PET) studies that investigate these risk factor variables from one study population pre-operatively and after bariatric surgery. The objectives of this study are to measure effect of obesity on brain structure and molecular pathways, food-stimuli mediated brain activation response, on hormones affecting both feeding and energy balance as well as on bone metabolism and bone marrow fat. The study consists of two phases. In the first phase the studies are performed at baseline before bariatric surgery and in the second phase post-operatively after 6 months. Regional free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral fat, pancreas, liver, brain, intestine and the bone are studied with PET and 14(R, S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). Changes in body fat distribution, in ectopic fat and fat content of key organs are investigated with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). ). Cardiac functioning is studied with echocardiography and functional MRI (fMRI) and ectopic fat in and around the heart using MRI and MRS. Brain reward system response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter volumes using diffusion tensor imaging (DTI). Brain neurotransmitter system will be measured with [11C]raclopride and [11C]carfentanil and PET. In the second part of the study the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass. The objective is also to study whether less invasive sleeve gastrectomy is as beneficial in terms of weight loss and co-morbid diseases as more invasive Roux-en-Y gastric bypass and to compare the changes in tissue metabolism between these two surgical procedures. The study consists totally of 60 study subjects. Of these 40 are morbidly obese adults, BMI
Status: Recruiting Start Date: January 2011 Completion Date: December 2014
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Morbid Obesity Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Morbid Obesity. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Morbid Obesity studies are federally regulated with strict guidelines to protect patients.

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