Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians
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| ClinicalTrials.gov Identifier: NCT00340132 |
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Recruitment Status :
Completed
First Posted : June 21, 2006
Last Update Posted : February 14, 2023
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Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion.
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Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.
| Condition or disease |
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| Weight Gain Overweight Insulin Resistance Obesity Diabetes Mellitus, Type 2 |
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion.
<TAB>
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.
| Study Type : | Observational |
| Actual Enrollment : | 1759 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Cross-Sectional and Longitudinal Studies of 'Pre-Diabetes' |
| Actual Study Start Date : | January 1, 1983 |
| Group/Cohort |
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Adult volunteers
Volunteers aged 18-55 who are healthy as determined by medical history, physical examination, and laboratory tests
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- Glucose tolerance via oral glucose tolerance test (OGTT) [ Time Frame: Baseline, and after 180 minutes on day 4 ]Measured via OGTT after ingestion of 75 grams of glucose over 2 minutes
- Glucose tolerance via intravenous glucose tolerance test (IVGTT) [ Time Frame: Baseline and after 10 minutes on day 5 ]Measured via IVGTT after administration of a glucose bolus (25 g as a 50% solution injected over 3 minutes)
- Basal endogenous glucose production [ Time Frame: Baseline, and after 100 minutes on day 10 ]Assessed using deuterium (D-6,6 2H) glucose as a tracer, infused as a 10 mL bolus followed by 0.150 mL/min for a total of 350 minutes
- 24-hour metabolic rate [ Time Frame: Baseline and after 23.5 hours on day 7 ]Assessed from the rates of caloric expenditure and substrate utilization while in the human respiratory chamber for 24 hours
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
Subjects from all racial and ethnic backgrounds will be invited to participate if they are:
- Ages: 18-55 years old (up to 2200 participants)
- Gender: male or female
EXCLUSION CRITERIA:
Subjects will be excluded who are:
- Taking medication for a chronic illness.
- Have any acute or chronic diseases or conditions not specifically mentioned that in the opinion of the provider may interfere with the study or decrease safety for participation will be considered exclusionary.
- Women who currently pregnant or breastfeeding.
- Positive for drug and/or nicotine use.
All medications and alcohol consumption are to be stopped for two weeks prior to admission. A urine drug-screening test for drugs such as narcotics, marijuana, and barbiturates will be performed on everyone to exclude from the study people whose urine show active or recent drug use. A positive drug test could confound the results of the study in an unpredictable manner. The results of this test will become a part of the patient s medical records and may be released if requested (please see page 6 of the consent for details regarding medical records release).
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): NCT00340132
| United States, Arizona | |
| NIDDK, Phoenix | |
| Phoenix, Arizona, United States, 85014 | |
| Principal Investigator: | Jonathan A Krakoff, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00340132 |
| Other Study ID Numbers: |
9999820136 OH82-DK-0136 |
| First Posted: | June 21, 2006 Key Record Dates |
| Last Update Posted: | February 14, 2023 |
| Last Verified: | January 21, 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Insulin Sensitivity Insulin Secretion Glucose Tolerance |
Adipose Tissue Preadipocytes Natural History |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Prediabetic State Overweight Weight Gain |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Body Weight Hyperinsulinism Body Weight Changes |