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Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) Clinical research trials and Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD). Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) clinical trial. Human subjects often get the best healthcare available for their Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD) condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD)  Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD)
Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD)
For Condition: Cystic Fibrosis,Diabetes Mellitus
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: People with CF have a high incidence of diabetes, called CFRD. CFRD is an important cause of worsened morbidity and mortality, thus understanding the pathophysiology underlying its development is imperative. Insulin deficiency has been well recognized as one cause of CFRD; however the clinical presentation and studies of pathogenesis indicate that the etiology is more complex. There is strong evidence that normal metabolism of carbohydrate, protein and fat is altered in CF. We believe that the inflammatory response to chronic underlying lung disease is responsible for insulin resistance and alters substrate metabolism, and that these changes, in addition to insulin deficiency cause CFRD. Our global hypothesis is that hyperglycemia is caused, in part, by high rates of gluconeogenesis resulting from excessive amino acid substrate availability caused by cytokine-mediated protein catabolism. We further hypothesize that inflammation alters normal fatty acid metabolism leading to lipogenesis, an energy wasteful pathway. We will recruit 24 adult CF subjects and 10 controls (similar in distribution in lean tissue mass, age and gender) and will categorize them according to glucose tolerance (OGTT), as well as insulin secretion and insulin sensitivity using the Tolbutamide-stimulated IVGTT and the Minimal Model. Clinical status will be characterized by measuring pulmonary function and modified NIH scores, in addition to measuring levels of circulating cytokines. Gluconeogenesis (GNG) will be quantified by measuring the incorporation 2H into the 2nd, 5th and 6th carbons of glucose. Amino acid turnover rates will be measured using stable isotopes of lactate and alanine and whole body protein turnover (WBPT) will be measured using [1-13C]leucine and [15N2]urea. Fat metabolism will be evaluated by measuring ketone body turnover using stable isotopes, and by quantifying lipogenesis using the isotopomer equilibration method. Key enzymes of fatty acid metabolism will also be measured. We will utilize indirect calorimetry to measure resting energy expenditure. Subjects will be recruited from the CF centers at the University of Texas- Southwestern and the South Central CF Consortium. Our proposal is intended to better describe the unique metabolism of people with CF, and to provide a comprehensive evaluation of pathophysiologic changes which contribute to the development of CFRD and to wasting; and are part of the applicant's long-range goal which is to identify the underlying causes of CF related diabetes and catabolism so that disease-specific therapies can be developed. We fully expect that the proposed studies will provide new and important information.
Details:
Eligibility:
Study Type: Interventional, Diagnostic, Non-Randomized
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria:
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 58603DK;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082238
Other Diabetes Mellitus Studies:
1. Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
2. Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD)
3. Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
4. Benefits and Risks of Newborn Screening for Cystic Fibrosis
5. Bone Health of People with Cystic Fibrosis
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Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD)
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