A Phase 2 interventional study of Diabetes Genetic Counseling and No genetic counseling in Pre-diabetes, Overweight and Metabolic Syndrome, sponsored by Massachusetts General Hospital. Status unknown at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2011-07-20.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Prevention
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Inclusion Criteria:
Subjects will have been genotyped and will received genetic counseling based on their results
Behavioral: Diabetes Genetic Counseling
Patients will not be genotyped and will therefore not receive genetic counseling
Behavioral: No 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
These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program
stage of change
Time frame: baseline, after counseling, after completing program (3 months)
program attendance
Time frame: 3 months
This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital