Overview

This trial is active, not recruiting.

Conditions pre-diabetes, overweight, metabolic syndrome
Treatments diabetes genetic counseling, no genetic counseling
Phase phase 2
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects will have been genotyped and will received genetic counseling based on their results
diabetes 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
(Placebo Comparator)
Patients will not be genotyped and will therefore not receive genetic counseling
no genetic counseling
These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Primary Outcomes

Measure
stage of change
time frame: baseline, after counseling, after completing program (3 months)

Secondary Outcomes

Measure
program attendance
time frame: 3 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.