Genetic Counseling and Lifestyle Change for Diabetes Prevention (GC/LC)

Mass General Brigham

Status and phase: Unknown; Phase 2

Conditions: Overweight; Pre-diabetes; Metabolic Syndrome

Treatments: Behavioral: No genetic counseling; Behavioral: Diabetes Genetic Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01034319

R21DK084527 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups, including a placebo group

Diabetes Genetic Counseling

Experimental group

Description:

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

Treatment:

Behavioral: Diabetes Genetic Counseling

No Genotyping or Counseling

Placebo Comparator group

Description:

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

Treatment:

Behavioral: No genetic counseling