Metabolic Syndrome, Overweight, Pre-diabetes
Conditions
Keywords
type 2 diabetes, genetics, genetic counseling, diabetes prevention
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.
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.
Interventions
BEHAVIORALDiabetes 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
BEHAVIORALNo genetic counseling
These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| stage of change | baseline, after counseling, after completing program (3 months) |
Secondary
| Measure | Time frame |
|---|---|
| program attendance | 3 months |
Countries
United States
Outcome results
None listed