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: July 11, 2014
Last verified: July 2014

January 29, 2010
July 11, 2014
August 2010
March 2013   (final data collection date for primary outcome measure)
Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
weight 3 months post-enrollment
weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01060540 on ClinicalTrials.gov Archive Site
  • Insulin Resistance (HOMA2-IR) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Calculated using the updated homeostasis model assessment (HOMA) calculator at http://www.dtu.ox.ac.uk/homacalculator/

    Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance.

  • Perceived Lifetime Risk of Type 2 Diabetes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)
  • Daily Caloric Intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Estimated daily caloric intake based on self-reported frequency and amount of intake of specific foods over the past 3 months as assessed by the Block Brief Food Frequency Questionnaire
  • Moderate Intensity Physical Activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report based on the long version of the International Physical Activity Questionnaire. Moderate physical activity was queried in the domains of work (e.g., carrying light loads), transportation (e.g., bicycling), domestic chores and gardening (e.g., sweeping, raking), and leisure-time (e.g., bicycling, swimming).
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 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.

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.

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
  • Behavioral: Conventional risk counseling
    Risk based on lifetime risk, fasting plasma glucose results, and family history.
  • Behavioral: eye disease counseling
    addresses risk for age-related macular degeneration, glaucoma, cataracts
  • Experimental: CR+G
    conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
    Interventions:
    • Genetic: genetic testing for type 2 diabetes
    • Behavioral: Conventional risk counseling
  • Active Comparator: CR+EYE
    conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
    Interventions:
    • Behavioral: Conventional risk counseling
    • Behavioral: eye disease counseling

*   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
July 2014

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