Genetic Testing for Type 2 Diabetes

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-03-31

Brief Summary

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In this 6-month randomized, controlled trial, we examined whether providing participants with genetic test results and counseling regarding their risk for type 2 diabetes would motivate them to improve their health behaviors and lose weight to reduce their diabetes risk. We hypothesized that participants who received conventional diabetes counseling plus genetic test results and counseling would have at least 6 lb greater weight loss at 3 months than participants who received conventional diabetes counseling without genetic test results.

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Detailed Description

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In this 6-month randomized, controlled trial, we evaluated the impact of genetic testing for type 2 diabetes on psychological, health behavior, and clinical outcomes. Eligibility criteria included age 21 to 65 years, overweight or obese (body mass index \[BMI\] \>27 kg/m2), and no prior diagnosis of type 2 diabetes. At baseline, participants (N=601) had conventional risk factors assessed, including demographics, fasting plasma glucose (FPG), and family history. They also provided blood samples for genetic testing of TCF7L2, PPARG, and KCNJ11, three genes that confer elevated risk for development of type 2 diabetes. Participants were then randomized to receive conventional counseling plus control eye disease counseling (CR+EYE) or conventional counseling plus genetic test results (CR+G). Two to four weeks following the baseline visit, when the genetic test results were available, participants returned for a visit with a genetic counselor. All participants received conventional risk counseling based on their lifetime population risk, FPG results, and family history. Next, participants were informed of their randomization assignments; CR+EYE participants received counseling on eye diseases, whereas CR+G participants received genetic counseling. Then perceived risk, affect, self-efficacy, and readiness to change were assessed. All other outcomes were also assessed at 3 and 6 months.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CR+G

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes

Group Type EXPERIMENTAL

genetic testing for type 2 diabetes

Intervention Type GENETIC

TCF7L2, PPARG, or KCNJ11

Conventional risk counseling

Intervention Type BEHAVIORAL

Risk based on lifetime risk, fasting plasma glucose results, and family history.

CR+EYE

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling

Group Type ACTIVE_COMPARATOR

Conventional risk counseling

Intervention Type BEHAVIORAL

Risk based on lifetime risk, fasting plasma glucose results, and family history.

eye disease counseling

Intervention Type BEHAVIORAL

addresses risk for age-related macular degeneration, glaucoma, cataracts

Interventions

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genetic testing for type 2 diabetes

TCF7L2, PPARG, or KCNJ11

Intervention Type GENETIC

Conventional risk counseling

Risk based on lifetime risk, fasting plasma glucose results, and family history.

Intervention Type BEHAVIORAL

eye disease counseling

addresses risk for age-related macular degeneration, glaucoma, cataracts

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* body mass index \>27 kg/m2
* baseline fasting plasma glucose \<=125 mg/dL

Exclusion Criteria

* prior diagnosis of type 2 diabetes
* fasting plasma glucose \>125 mg/dL on more than one occasion
* HbA1c \> 7%
* taking diabetes medication
* actively losing weight
* enrolled in research study focusing on lifestyle changes
* unable to provide informed consent or answer survey questions unassisted
* residing in nursing home or receiving home health care
* active diagnosis of psychosis or dementia
* at least one error on 6-item cognitive screener

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No