Genetic Counseling and Lifestyle Change for Diabetes Prevention (GC/LC)
Primary Purpose
Pre-diabetes, Overweight, Metabolic Syndrome
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diabetes Genetic Counseling
No genetic counseling
Sponsored by
About this trial
This is an interventional prevention trial for Pre-diabetes focused on measuring type 2 diabetes, genetics, genetic counseling, diabetes prevention
Eligibility 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
Sites / Locations
- Massachusetts General Hospital Practice Based Research Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diabetes Genetic Counseling
No Genotyping or Counseling
Arm Description
Subjects will have been genotyped and will received genetic counseling based on their results
Patients will not be genotyped and will therefore not receive genetic counseling
Outcomes
Primary Outcome Measures
stage of change
Secondary Outcome Measures
program attendance
Full Information
NCT ID
NCT01034319
First Posted
December 16, 2009
Last Updated
July 19, 2011
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01034319
Brief Title
Genetic Counseling and Lifestyle Change for Diabetes Prevention
Acronym
GC/LC
Official Title
Genetic Counseling and Lifestyle Change for Diabetes Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Overweight, Metabolic Syndrome
Keywords
type 2 diabetes, genetics, genetic counseling, diabetes prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetes Genetic Counseling
Arm Type
Experimental
Arm Description
Subjects will have been genotyped and will received genetic counseling based on their results
Arm Title
No Genotyping or Counseling
Arm Type
Placebo Comparator
Arm Description
Patients will not be genotyped and will therefore not receive genetic counseling
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Genetic Counseling
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
No genetic counseling
Intervention Description
These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program
Primary Outcome Measure Information:
Title
stage of change
Time Frame
baseline, after counseling, after completing program (3 months)
Secondary Outcome Measure Information:
Title
program attendance
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Grant, MD MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Practice Based Research Network
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22933432
Citation
Grant RW, O'Brien KE, Waxler JL, Vassy JL, Delahanty LM, Bissett LG, Green RC, Stember KG, Guiducci C, Park ER, Florez JC, Meigs JB. Personalized genetic risk counseling to motivate diabetes prevention: a randomized trial. Diabetes Care. 2013 Jan;36(1):13-9. doi: 10.2337/dc12-0884. Epub 2012 Aug 28.
Results Reference
derived
PubMed Identifier
22302620
Citation
Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.
Results Reference
derived
Learn more about this trial
Genetic Counseling and Lifestyle Change for Diabetes Prevention
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