Genetic Counseling and Lifestyle Change for Diabetes Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Genetic Counseling and Lifestyle Change for Diabetes Prevention

Conditions
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Pre-diabetes, Overweight, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Diabetes Genetic Counseling
* Behavioral: No genetic counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stage of change |  | baseline, after counseling, after completing program (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| program attendance |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, genetics, genetic counseling, diabetes prevention