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Home > "L" Clinical Trials Conditions > Leptin to Treat Lipodystrophy  Leptin to Treat Lipodystrophy
Leptin to Treat Lipodystrophy
For Condition: Lipodystrophy
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and liver disease due to fat accumulation. Patients age 5 and older with significant lipodystrophy may be eligible for this study. Candidates will be screened with a physical examination and blood tests. Participants will be admitted to the NIH Clinical Center for 10 days for the following studies before beginning 12 months of leptin therapy: - Insulin tolerance test -measures blood sugar levels after intravenous (IV) administration of insulin. Blood samples are collected through the IV tube at various intervals during the 1-hour test. - Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. - Fasting blood tests - to measure blood count, blood lipids and various hormones and assess liver function. - Resting metabolic rate - to measure the amount of oxygen breathed at rest in order to calculate how many calories are required to maintain resting body functions. - Magnetic resonance imaging of the liver and other organs, and of muscle and fat. - Pelvic ultrasound in women - to detect ovarian cysts. - Estimation of body fat - measurements of height, weight, waist, hip size, and skin folds over the arms and abdomen to estimate body fat content. - Oral glucose tolerance test -measures blood sugar and insulin levels. The patient drinks a very sweet drink containing glucose (sugar), after which blood samples are collected through an IV tube in an arm vein at various intervals during the 3-hour test. - Intravenous glucose tolerance test -measures tissue response to insulin and glucose after glucose injection and insulin infusion. Blood is collected over 3 hours to measure insulin and glucose levels. - Appetite level and food intake - to measure hunger level and caloric intake. Patients are questioned about their hunger level, given a variety of foods they may choose to eat and questioned again at various intervals about hunger level. On another day, patients are given breakfast (usually a milkshake) and when they want to eat again, the appetite level and caloric intake study is repeated. - Hormone function tests - the function of three hormones influenced by leptin (corticotropin-releasing hormone, thyrotropin-releasing hormone and luteinizing hormone-releasing hormone) are assessed. The hormones are injected intravenously and then blood samples are drawn. - Questionnaire - patients complete a questionnaire about their activities and how they feel. - 24-hour urine collections - to measure specific hormones, proteins and sugars excreted in the urine. Additional studies may include blood tests for genetic studies of lipodystrophy, a muscle biopsy to study muscle proteins involved in regulating energy expenditure before and after leptin replacement, and examination of a surgical specimen (if available) to study molecules that may be involved in energy storage and use. When the above tests are completed, leptin therapy begins. The drug is injected under the skin twice a day for 4 months and then once a day, if feasible. The dose is increased at the 1- and 2-month visits. Follow-up visits at 1, 2, 4, 6, 8 and 12 months after therapy starts include a physical examination, blood tests and a meeting with a dietitian. At the end of 12 months, all baseline studies described above are repeated. Patients record their symptoms weekly throughout the study. Those with diabetes measure their blood glucose levels daily before each meal and at bedtime.
Details: Lipoatrophic diabetes is a syndrome characterized by insulin resistance in association with a paucity of adipose tissue. Patients with severe lipoatrophy die prematurely, typically from the complications of diabetes or liver disease. Experiments with lipoatrophic mice suggest that the insulin resistance is caused by the lack of adipose tissue. Adipose tissue normally produces leptin, a hormone that increases insulin action. For the last three years, we have been studying the extent that leptin deficiency causes diabetes in lipoatrophic patients. In fact, in our initial study we have seen nearly 60% amelioration of fasting glucose, triglycerides and free fatty acid levels and about 2% actual decreases from baseline HbA1c levels with 4 month's of leptin replacement therapy. This response has continued to be sustained, as we continue to follow patients that have now received leptin replacement therapy for three years. This study monitors the safety and efficacy of leptin replacement in children and adults. We are looking at the long-term effects of leptin replacement on continued therapy. We continue to evaluate the efficacy in a broader leptin deficient population of patients with lipodystrophy. Current inclusion criteria look at female patients with leptin level (less than 6ng/mL) and male patients (less than 3ng/mL) and seeking patients meeting these criteria will continue. We will treat patients with recombinant leptin (A-100) injections looking at long term efficacy. Inpatient studies will be performed at baseline, 4, 8 and 12 months and every 6 months thereafter. In this long-term replacement protocol, we will monitor metabolic control (e.g. glucose, insulin, and triglyceride levels) as primary outcome measures. Ancillary studies will evaluate the effect of recombinant leptin on other hormonal axes, growth and development and on liver pathology.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All ethnic groups. Males and females. -Age greater than 5 years old. -Clinically significant lipodystrophy, identified by the study physician during the physical examination as an absence of fat outside the range of normal variation and/or identified as a disfiguring factor by the patient. Circulating leptin levels less than 6.0 ng/ml in females and less than 3.0 ng/ml in males as measured by Linco assay on at least 2 occasions (specify when) obtained from pooled samples collected fasting at 6 AM, 6:30 AM and 7 AM. Presence of diabetes as defined by the 1997 ADA criteria a. Fasting plasma glucose 126 mg/ml, or b. 2 hour plasma glucose 200 mg/dl following a 75 gram oral glucose load, or c. Diabetic symptoms with a random plasma glucose 200 mg/dl Fasting insulin greater than 30 micro units/ml. Fasting hypertriglyceridermia greater 200 mg/dl EXCLUSION CRITERIA: Pregnant women, women in their reproductive years who do not use an effective method of birth control, currently nursing or lactating within 6 weeks of having completed nursing, and persons who are unable to provide informed consent will be excluded from the study. Exclusions for underlying diseases likely to increase side effects or hinder objective data collection: - Known infectious liver disease - Current alcohol or substance abuse - Psychiatric disorder impeding competence or compliance - Active tuberculosis - Use of anorexiogenic drugs - Other condition which in the opinion of the clinical investigators would impede completion of the study -Subjects who have known hypersensitivity to E. Coli derived proteins.
Total Enrollment: 40
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020022; 02-DK-0022
Study Start Date: October 25, 2001
Record last reviewed: October 6, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025883
Other Lipodystrophy Studies:
1. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
2. The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
3. Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy
4. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
5. The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
Related Studies:
Other Lipodystrophy Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Leptin to Treat Lipodystrophy
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