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

Tracking Information

First Received Date ^ICMJE

December 16, 2009

Last Updated Date

July 19, 2011

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01034319 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

program attendance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Genetic Counseling and Lifestyle Change for Diabetes Prevention

Official Title ^ICMJE

Genetic Counseling and Lifestyle Change for Diabetes Prevention

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Pre-diabetes
Overweight
Metabolic Syndrome

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01034319

Other Study ID Numbers ^ICMJE

R21DK084527, R21DK084527

Has Data Monitoring Committee

Yes

Responsible Party

Richard W Grant MD MPH, Assistant Professor, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Richard W Grant, MD MPH

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

July 2011

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

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