Genetic Counseling and Lifestyle Change for Diabetes Prevention

Phase 2

• Conditions: Pre-diabetes; Overweight; Metabolic Syndrome
• Interventions: Behavioral: Diabetes Genetic Counseling; Behavioral: No genetic counseling

• Registration Number: NCT01034319
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20
• Primary Completion: 2011-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Overweight (Body mass index ≥ 29.1 kg/m2 in men, ≥ 27.2 kg/m2 in women) with at least 2 other formal criteria for Metabolic Syndrome (see Table -NCEP ATP-III Criteria)
• Adult (> 21 years of age)
• No diagnosis or treatment for diabetes (Type 1 or Type 2) or cardiovascular disease (e.g. myocardial infraction, coronary bypass surgery, congestive heart failure, peripheral vascular disease)
• Physically able and willing to participate in a 12-week group session curriculum for weight loss and dietary change
• Able to understand and communicate effectively in English

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Genetic Counseling	Diabetes Genetic Counseling	Subjects will have been genotyped and will received genetic counseling based on their results
No Genotyping or Counseling	No genetic counseling	Patients will not be genotyped and will therefore not receive genetic counseling

Primary Outcome Measures

Name	Time	Method
stage of change	baseline, after counseling, after completing program (3 months)

Secondary Outcome Measures

Name	Time	Method
program attendance	3 months

Trial Locations

Locations (1)

Massachusetts General Hospital Practice Based Research Network; 🇺🇸 Boston, Massachusetts, United States