Genetic Counseling and Lifestyle Change for Diabetes Prevention

Metabolic Syndrome Clinical Trial

— GC/LC  

Official title:

Genetic Counseling and Lifestyle Change for Diabetes Prevention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01034319
• Other study ID #: R21DK084527
• Secondary ID: R21DK084527
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 16, 2009
• Last updated: July 19, 2011
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Syndrome
• Metabolic Syndrome X
• Overweight
• Pre-diabetes

Intervention

Behavioral:
• 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
• No genetic counseling
These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Practice Based Research Network	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stage of change		baseline, after counseling, after completing program (3 months)	No
Secondary	program attendance		3 months	No