Genetic Counseling and Lifestyle Change for Diabetes Prevention
This trial is active, not recruiting.
|Conditions||pre-diabetes, overweight, metabolic syndrome|
|Treatments||diabetes genetic counseling, no genetic counseling|
|Sponsor||Massachusetts General Hospital|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||December 2009|
|End date||August 2011|
|Trial size||90 participants|
|Trial identifier||NCT01034319, R21DK084527|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
stage of change
time frame: baseline, after counseling, after completing program (3 months)
time frame: 3 months
Male or female participants at least 21 years old.
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
|Official title||Genetic Counseling and Lifestyle Change for Diabetes Prevention|
|Principal investigator||Richard W Grant, MD MPH|
|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.|
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