Genetic Studies of Insulin and Diabetes

Recruiting now

Conditions studied: Diabetes Mellitus, Severe Insulin Resistance

In brief

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.

Key facts

Study ID

NCT00001987

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

1200

Starts

1976-02-01

Last updated by the study team

2026-08-03

Who can join

Age: 1 and older, up to 120. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Patients with evidence for insulin resistance or a disorder associated with severe insulin resistance
• -none
• Family members of patients, above
• -Pregnant at the time of enrollment
• Healthy control subjects Cohort 1
• Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.
• Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g. niacin, fish oil, red yeast rice)
• History of diabetes or abnormal glucose tolerance
• Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent/assent, or to comply with study procedures
• Pregnant or lactating
• Healthy control subjects Cohort 2. Subjects from Cohort 1 may NOT be included in Cohort 2 if they have any of the following ADDITIONAL exclusion criteria.
• Abnormal screening labs, including the following:
• ALT or AST more than 1.5 times the upper limit of normal
• Glycosuria
• Clinically significant anemia
• Low eGFR (<60 mL/min/1.73m\^2)
• Any other abnormality that, in the opinion of the investigator, will increase risk to the subject from participation, or interfere with interpretation of study data

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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