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 : November 2, 2018
|First Submitted Date||January 28, 2000|
|First Posted Date||January 31, 2000|
|Last Update Posted Date||November 2, 2018|
|Study Start Date||January 30, 1976|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00001987 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Genetic Studies of Insulin and Diabetes|
|Official Title||Natural History of Disorders of Insulin Resistance|
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.
Insulin is the key hormone responsible for regulating the level of glucose in plasma. In several disease states (e.g., obesity, non-insulin-dependent diabetes mellitus, and acromegaly), the target cells are resistant to insulin action. 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.
The purpose of this protocol is to threefold:
Patients with evidence for insulin resistance will be eligible to participate in this study. We particularly focus our study on the following four groups of patients:
The frequency of visits and testing to be performed will vary due to the clinical heterogeneity of the patients studied as well as their worldwide geographic distribution, and will be adjusted on an individual basis. The total quantity of blood collected will be adjusted to remain within the approved NIH guidelines appropriate to the individual s age and size. The testing will include all or some of the following studies:
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
At least one of the following is required:
Hyperinsulinemia (i.e. greater than 30 microgramsU/mL).
Clinical presence of type 2 diabetes mellitus.
High insulin requirement (> 2 units per kg per day or > 200 units total per day)
Phenotypic features suggesting a defect in glucose/lipid metabolism:
Family members of patients with known disease states of insulin action.
|Ages||6 Months and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries||United Kingdom|
|Other Study ID Numbers||760006
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )|
|Study Sponsor||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 30, 2018|