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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01034319
First received: December 16, 2009
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pre-diabetes
Overweight
Metabolic Syndrome
 Behavioral: Diabetes Genetic Counseling
Behavioral: No genetic counseling
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Genetic Counseling and Lifestyle Change for Diabetes Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • stage of change [ Time Frame: baseline, after counseling, after completing program (3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • program attendance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes Genetic Counseling
Subjects will have been genotyped and will received genetic counseling based on their results
 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
Placebo Comparator: No Genotyping or Counseling
Patients will not be genotyped and will therefore not receive genetic counseling
 Behavioral: No genetic counseling
These subjects will not be genotyped or counseled prior to enrollment 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034319

Locations
United States, Massachusetts
Massachusetts General Hospital Practice Based Research Network
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Richard W Grant, MD MPH Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard W Grant MD MPH, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01034319     History of Changes
Other Study ID Numbers: R21DK084527, R21DK084527
Study First Received: December 16, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
type 2 diabetes
genetics
genetic counseling
diabetes prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Overweight
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hyperglycemia
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 19, 2013