Genetic Counseling and Lifestyle Change for Diabetes Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pre-diabetes Overweight Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diabetes Genetic Counseling

Subjects will have been genotyped and will received genetic counseling based on their results

Group Type EXPERIMENTAL

Diabetes Genetic Counseling

Intervention Type BEHAVIORAL

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

No Genotyping or Counseling

Patients will not be genotyped and will therefore not receive genetic counseling

Group Type PLACEBO_COMPARATOR

No genetic counseling

Intervention Type BEHAVIORAL

These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Interventions

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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

Intervention Type BEHAVIORAL

No genetic counseling

These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No