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Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00340132
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:

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
Weight Gain Overweight Insulin Resistance Obesity Diabetes Mellitus, Type 2

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Group/Cohort
Adult volunteers
Volunteers aged 18-55 who are healthy as determined by medical history, physical examination, and laboratory tests



Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample from eligible participants from greater Phoenix metropolitan area@@@@@@
Criteria
  • 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).


Information from the National Library of Medicine

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


Locations
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United States, Arizona
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jonathan Krakoff, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: January 18, 2022
Last Verified: December 17, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Insulin Sensitivity
Insulin Secretion
Glucose Tolerance
Adipose Tissue
Preadipocytes
Natural History
Additional relevant MeSH terms:
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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