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NCT00707616 Clinical Trial

Common Genetic Variation and Type 2 Diabetes

Pre-diabetes Clinical Trial

Official title:
The Effect of Diabetes-associated Gene Variation on Glucose Metabolism in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00707616
Other study ID # 348-05
Secondary ID
Status Completed
Phase N/A
First received June 27, 2008
Last updated January 18, 2013
Start date March 2006
Est. completion date December 2012

Study information
Verified date January 2013
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Type 2 diabetes is a common metabolic disorder arising from a complex interaction between genetic predisposition and the environment. The development of this disorder is preceded by impaired glucose tolerance and elevated fasting glucose which also carry adverse cardiovascular risk. To date a few common genetic variants have been reliably associated with predisposition to type 2 diabetes. However, it is uncertain how these genes interact to alter insulin secretion and insulin action prior to the development of type 2 diabetes. We propose to utilize an established population-based cohort to determine how common genetic variants associated with type 2 diabetes alter the response to an oral glucose challenge in people without overt type 2 diabetes. This will enable us to understand how common variants alone or in combination alter whole-body glucose physiology and predispose to type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 80 Years
Eligibility Inclusion Criteria:

- Fasting blood glucose < 126mg/dL

Exclusion Criteria:

- Fasting blood glucose > 126mg/dL

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• Oral glucose tolerance test
one time 75g oral glucose tolerance test for measurement of insulin secretion and action

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic University of Padua

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disposition Index Measured by 7-sample, 2Hr OGTT 2 hr No
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