NCT01034319

Genetic Counseling and Lifestyle Change for Diabetes Prevention

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Controls will not be tested. All subjects will be enrolled in a 12-week diabetes prevention program.

Detailed description

This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. We will randomize subjects with pre-diabetes to genetic testing vs. no genetic testing in order to obtain an unconfounded test of the hypothesis that genetic testing will change patient behavior. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Because patients can receive either "Higher risk" or "Lower risk" genetic test results, we will separately examine the impact of "Higher risk" and "Lower risk" test results compared to untested controls. All subjects will be enrolled in a 12-week diabetes prevention program.

Conditions

• Pre-diabetes
• Overweight
• Metabolic Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes Genetic Counseling	Subjects will be genotyped based on a 37-allele aggregate score and counseled regarding the implications of the results prior to enrollment in a 12-week diabetes prevention program
BEHAVIORAL	No genetic counseling	These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-08-01
• Completion: 2012-12-01
• First posted: 2009-12-17
• Last updated: 2011-07-20

Locations

1 site across 1 country: United States