Scientists launch major study to uncover secrets of insulin resistance
NCT ID NCT00001987
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 17 times
Summary
This study aims to learn more about insulin resistance and diabetes by collecting blood and skin samples from up to 1,200 participants, including patients with severe insulin resistance and their family members. Researchers will study genetics and how insulin works in the body to better understand the causes of these conditions. No treatments are tested; the goal is to gather information for future research.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 1976
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects with severe insulin resistance disorders.
- Ages
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6 months to 120 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Three categories of subjects will be included in this study: * Patients with evidence for insulin resistance or a disorder associated with severe insulin resistance, including: * Patients with various syndromes of lipodystrophy * Patients with known or suspected mutations on the insulin receptor gene * Patients with known or suspected autoantibodies to the insulin receptor * Patients with other severe forms of insulin resistance * Family members of patients, above * Healthy control subjects without insulin resistance Inclusion criteria for each group of subjects are given below: * Patients with evidence for severe insulin resistance or a disorder associated with severe insulin resistance must meet all of the following criteria: * Suspected severe insulin resistance, or a disorder associated with severe insulin resistance, as evidenced by one or more of the following: * Hyperinsulinemia (i.e. fasting insulin \>30microU/mL) * High insulin requirement (\> 2 units per kg per day or \> 200 units total per day) * Phenotypic features suggesting a defect in glucose/lipid metabolism: * Acanthosis nigricans * Lipodystrophy/abnormal fat distribution * Xanthomata * Fatty liver * Known or suspected mutations of the insulin receptor gene * Known or suspected autoantibodies to the insulin receptor * Age \>= 6 months * Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. * Family members of patients, above (either affected or unaffected) must meet all of the following criteria: * Biological relatives of patients in category (1) in whom a genetic cause of insulin resistance is known or suspected. * Age \>= 6 months * Ability of subject (and/or legal guardian, for minor subjects) to understand and the willingness to sign a written informed assent/consent document. * Healthy control subjects Cohort 1 must meet all of the following criteria. * Ability of subject (and/or legal guardian, for minor subjects) to understand and the willingness to sign a written informed assent/consent document. * In good general health with no known active medical conditions as evidenced by medical history * Age \>= 12 years * Healthy control subjects Cohort 2. Subjects from Cohort 1 may be included in Cohort 2 if they meet the following ADDITIONAL inclusion criteria. * Fasting glucose \<100 mg/dL * HbA1c \<5.7% * Fasting triglycerides \<150 mg/dL * Fasting insulin \<30 mcU/mL * BMI \<27 kg/m\^2 or \<90th percentile for age/sex (whichever is lower) EXCLUSION CRITERIA: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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