Common Genetic Variation and Type 2 Diabetes

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00707616
• Collaborator: University of Padova (Other)
• Enrollment: 190
• Location: 1
• Duration (Months): 81.1
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pre-diabetes	Other: Oral glucose tolerance test

Study Design

• Study Type: Observational
• Actual Enrollment: 190 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: The Effect of Diabetes-associated Gene Variation on Glucose Metabolism in Humans
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
A Subjects without type 2 diabetes living in Olmsted County, MN	Other: Oral glucose tolerance test; one time 75g oral glucose tolerance test for measurement of insulin secretion and action

Outcome Measures

Primary Outcome Measures

1. Disposition Index [2 hr]

   Measured by 7-sample, 2Hr OGTT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Fasting blood glucose < 126mg/dL

Exclusion Criteria:

• Fasting blood glucose > 126mg/dL

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• University of Padova

Investigators

• Principal Investigator: Adrian Vella, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adrian Vella, Professor of Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00707616
• Other Study ID Numbers: 348-05
• First Posted: Jul 1, 2008
• Last Update Posted: Jan 23, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Diabetes Mellitus; Prediabetic State

Study Results

No Results Posted as of Jan 23, 2013