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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034319
First Posted: December 17, 2009
Last Update Posted: July 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Genetic Counseling and Lifestyle Change for Diabetes Prevention

Resource links provided by NLM:


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) ]

Secondary Outcome Measures:
  • program attendance [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: July 20, 2011
Last Verified: July 2011

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

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