Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Genetic Counseling and Lifestyle Change for Diabetes Prevention (GC/LC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01034319
First received: December 16, 2009
Last updated: July 19, 2011
Last verified: July 2011

December 16, 2009
July 19, 2011
December 2009
August 2011   (final data collection date for primary outcome measure)
stage of change [ Time Frame: baseline, after counseling, after completing program (3 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01034319 on ClinicalTrials.gov Archive Site
program attendance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Genetic Counseling and Lifestyle Change for Diabetes Prevention
Genetic Counseling and Lifestyle Change for Diabetes 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pre-diabetes
  • Overweight
  • Metabolic Syndrome
  • 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
  • Behavioral: No genetic counseling
    These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program
  • Experimental: Diabetes Genetic Counseling
    Subjects will have been genotyped and will received genetic counseling based on their results
    Intervention: Behavioral: Diabetes Genetic Counseling
  • Placebo Comparator: No Genotyping or Counseling
    Patients will not be genotyped and will therefore not receive genetic counseling
    Intervention: Behavioral: No genetic counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
December 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01034319
R21DK084527, R21DK084527
Yes
Richard W Grant MD MPH, Assistant Professor, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Richard W Grant, MD MPH Massachusetts General Hospital
Massachusetts General Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP