Common Genetic Variation and Type 2 Diabetes | NCT00707616

Studies
Common Genetic Variation and Type 2 Diabetes

NCT00707616

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 23, 2013Estimated

Enrollment

190Actual

Phase

Not provided

Conditions

Pre-diabetes

Interventions

Oral glucose tolerance test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jun 27, 2008

First Submission Date that Met QC Criteria

Jun 30, 2008

First Posted Date

Jul 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2013

Last Update Posted Date

Jan 23, 2013Estimated

Name	Class
University of Padova	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Subjects without type 2 diabetes living in Olmsted County, MN	Other: Oral glucose tolerance test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral glucose tolerance test	Other	one time 75g oral glucose tolerance test for measurement of insulin secretion and action	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disposition Index	Measured by 7-sample, 2Hr OGTT	2 hr

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fasting blood glucose < 126mg/dL

Exclusion Criteria:

Fasting blood glucose > 126mg/dL

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy, non-diabetic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrian Vella, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D018149	Glucose Intolerance

Ancestor Terms

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005951	Glucose Tolerance Test

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided