Genetic Testing for Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01060540
First received: January 29, 2010
Last updated: April 11, 2014
Last verified: April 2014

January 29, 2010
April 11, 2014
August 2010
March 2013   (final data collection date for primary outcome measure)
weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01060540 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Genetic Testing for Type 2 Diabetes
The Impact of Genetic Testing for Type 2 Diabetes on Health Behaviors

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. There was no difference between groups on the primary outcome of weight (treatment difference 0.38 lb, 95% confidence interval -0.76, 1.51, p=0.51). There were no differences between groups for any secondary outcomes except caloric intake, which decreased more from baseline to 3 months in the CR+G arm than the CR+EYE arm (p=0.05).

In this 6-month randomized, controlled trial, we evaluated the impact of genetic testing for T2DM 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 T2DM. 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 T2DM. Participants were then randomized to receive conventional counseling only (CR) 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 participants received general health risk counseling on issues unrelated to T2DM, 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.

Mean age was 54 years; 42% of participants were White, 53% were Black, 80% were male, 30% had BMI 35 kg/m2, and 53% had moderate/high family-history-based DM risk. There was no difference between groups on the primary outcome of weight (treatment difference 0.38 lb, 95% confidence interval -0.76, 1.51, p=0.51). There were no differences between groups for any secondary outcomes except caloric intake, which decreased more from baseline to 3 months in the CR+G arm than the CR+EYE arm (p=0.05).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Diabetes Mellitus
  • Genetic: genetic testing for type 2 diabetes
    TCF7L2, PPARG, or KCNJ11
  • Other: Conventional risk counseling for type 2 diabetes
    Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history.
  • Experimental: Arm 1
    conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
    Intervention: Genetic: genetic testing for type 2 diabetes
  • Active Comparator: Arm 2
    conventional risk counseling (lifetime risk, fasting plasma glucose, and family history)
    Intervention: Other: Conventional risk counseling for type 2 diabetes

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
601
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01060540
IBD 09-039
No
Department of Veterans Affairs
Department of Veterans Affairs
Duke University
Principal Investigator: Corrine I. Voils, PhD Department of Veterans Affairs
Department of Veterans Affairs
April 2014

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