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

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ClinicalTrials.gov Identifier: NCT00340132
Recruitment Status : Recruiting
First Posted : June 21, 2006
Last Update Posted : September 2, 2019
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:

The Pima Indians of Arizona have the highest prevalence and incidence of type 2 diabetes of any population in the world. Prospective analyses in this population have identified insulin resistance and a defect in early insulin secretion as risk factors for the development of the disease. A recent longitudinal analysis which tracked the development of diabetes in 17 Pima Indians 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 plan to study Pima Indian families 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.

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.

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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.


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Study Type : Observational
Estimated Enrollment : 99999999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cross-Sectional and Longitudinal Studies of "Pre-Diabetes"
Actual Study Start Date : August 18, 1982

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Group/Cohort
1
Community sample from eligible participants from greater Phoenix metropolitan area



Primary Outcome Measures :
  1. Determinants of insulin action, insulin secretion and weight gain [ Time Frame: Periodically at follow-up ]
    type 2 diabetes Weight gain


Secondary Outcome Measures :
  1. Genetic variants and tissue expression associated with insulin action, insulin secretion and adiposity [ Time Frame: ongoing ]


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:

Volunteers from all racial and ethnic backgrounds will be invited to participate if they are:

Ages: 18 - 55 years old

Gender: male or female.

  • Each subject who volunteers will be assigned to the clinical research ward physician who made the initial contact and he/she will be responsible for completion of all tests (see below) and compilation of data. This physician will consult with the subject's personal physician or other health care personnel involved with the patient in Sacaton. This includes sending a carefully written discharge summary to appropriate health care workers at the time of discharge.
  • 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).

EXCLUSION CRITERIA:

Subjects will be excluded who are on chronic medications for problems such as seizure disorders.

Exclusions for occasional medications will be at the discretion of the interviewing physician.

Women who are currently pregnant or breastfeeding will be excluded from the study.


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


Contacts
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Contact: Jonathan Krakoff, M.D. (602) 200-5217 jkrakoff@mail.nih.gov

Locations
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United States, Arizona
NIDDK, Phoenix Recruiting
Phoenix, Arizona, United States, 85014
Contact: Clifton Bogardus, M.D.    602-200-5311    cbogardus@phx.niddk.nih.gov   
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:
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     History of Changes
Other Study ID Numbers: 9999820136
OH82-DK-0136
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 29, 2019

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Prediabetic State
Overweight
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Hyperinsulinism
Body Weight Changes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs