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Genetic Studies of Insulin and Diabetes

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 400 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Eligibility criteria expanded, about 50 words

    Study description expanded, about 18 words; Publications: details revised at 9 of 9 entries

    Show what changed: Eligibility criteria
    * 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 [...] [...]
    Show what changed: Study description
    [...] orders, including their response to FDA approved therapies, and (4) To conduct ex vivo studies of the physiology and pathoph [...] e disorders, using cells and tissues collected in this study, and (5) To characterize social determinants of health in patients with insulin resistance and their relationship to health outcomes. Endpoints: Primary Endpoint: Genetic causes of insulin res [...]

  3. Minor

    33 amendments

    33 re-verifications since 2025-07-12, no change to tracked fields

    v366-v398

  4. Minor

    Interventions: HR-pQCT scan (Device)

    Study Status, Oversight, Arms and Interventionsv365

  5. Minor

    Study description expanded, about 14 words

    Show what changed: Study description
    [...] thophysiology of insulin resistance and its relationship to diabetes, dyslipidemia, cardiovascular disease, liver disease, kidney disease, reproductive function, bone disease, and other organ dysfunction, (2) To study the molecular genetics underlying various cau [...]

    Study Status, Study Descriptionv364

  6. Minor

    13 amendments

    13 re-verifications since 2025-02-12, no change to tracked fields

    v351-v363

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00001987
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Diabetes Mellitus, Severe Insulin Resistance
Enrollment 1,200 participants
Start Date
Updated on ClinicalTrials.gov