Genetic Studies of Insulin and Diabetes
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|ClinicalTrials.gov Identifier: NCT00001987|
Recruitment Status : Recruiting
First Posted : January 31, 2000
Last Update Posted : July 7, 2022
The study will allow researchers to obtain blood, plasma, DNA, and RNA for genetic studies of insulin. There will be a focus on the causes of insulin resistance and diabetes mellitus. Insulin is a hormone found in the body that controls the level of sugar in the blood. Insulin resistance refers to conditions like diabetes when insulin does not work properly. In this study researchers would like to compare patients with diabetes and other forms of insulin resistance to normal individuals. The study will investigate how insulin attaches to cells.
Researchers will take 4 to 6 ounces (100-150 ml) of blood from adult patients and may request up to 12 ounces (one unit) of blood if necessary. Skin samples may be taken for a biopsy if further genetic testing is necessary. In addition some patients may be asked not to eat for up to 72 hours prior to testing.
|Condition or disease|
|Diabetes Mellitus Severe Insulin Resistance|
Insulin is the key hormone responsible for regulating the level of glucose in plasma. In several disease states (e.g., obesity, type 2 diabetes, and acromegaly), the target cells are resistant to insulin action. Insulin resistance leads to metabolic complications including diabetes, dyslipidemia, cardiovascular disease, non-alcoholic fatty liver disease, and reproductive dysfunction. The intramural research program of the NIDDK has a long history of studying patients with rare disorders of extreme insulin resistance. We use what is learned from these rare patients both to develop therapeutics for rare diseases, and to apply what is learned to understand more common forms of insulin resistance.
Primary Objectives: (1) To understand the pathophysiology of insulin resistance and its relationship to cardiovascular disease, (2) To study the molecular genetics underlying various causes of insulin resistance and diabetes mellitus, and (3) To understand the natural history of insulin resistance disorders, including their response to FDA approved therapies.
Endpoints: Primary Endpoint: Genetic causes of insulin resistance
Secondary Endpoints: Diabetes control (hemoglobin A1c) and complications (rates of micro- and macrovascular disease)
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Natural History of Disorders of Insulin Resistance|
|Actual Study Start Date :||February 1, 1976|
Patients with severe insulin resistance
patients with severe insulin resistance manifesting with acanthosis nigricans, hyperinsulinemia, type A and B insulin resistance syndromes, and patients with lipodystrophy.
- Genetics of insulin resistance [ Time Frame: End of Study ]To discover the cause of the insulin resistance to better assist with treatment for it.
- Diabetes control [ Time Frame: every 6-12 months ]To help prevent additional health issues associated with poor glucose and insulin levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001987
|Contact: Megan S Startzell, R.N.||(301) email@example.com|
|Contact: Rebecca J Brown, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Rebecca J Brown, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|