GC/LC: Genetic Counseling and Lifestyle Change for Diabetes Prevention

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01034319

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-diabetes Overweight Metabolic Syndrome	Behavioral: Diabetes Genetic Counseling Behavioral: No genetic counseling	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Genetic Counseling and Lifestyle Change for Diabetes Prevention

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diabetes Genetic Counseling Subjects will have been genotyped and will received genetic counseling based on their results	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
Placebo Comparator: No Genotyping or Counseling Patients will not be genotyped and will therefore not receive genetic counseling	Behavioral: No genetic counseling These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Arm

Intervention/Treatment

Experimental: Diabetes Genetic Counseling

Subjects will have been genotyped and will received genetic counseling based on their results

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

Placebo Comparator: No Genotyping or Counseling

Patients will not be genotyped and will therefore not receive genetic counseling

Behavioral: No genetic counseling

These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Outcome Measures

Primary Outcome Measures

stage of change [baseline, after counseling, after completing program (3 months)]

Secondary Outcome Measures

program attendance [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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