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
  Purpose

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).


Condition Intervention
Diabetes Mellitus
Genetic: genetic testing for type 2 diabetes
Other: Conventional risk counseling for type 2 diabetes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Genetic Testing for Type 2 Diabetes on Health Behaviors

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 601
Study Start Date: August 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
Genetic: genetic testing for type 2 diabetes
TCF7L2, PPARG, or KCNJ11
Active Comparator: Arm 2
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history)
Other: Conventional risk counseling for type 2 diabetes
Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060540

Locations
United States, North Carolina
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Corrine I. Voils, PhD Department of Veterans Affairs
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01060540     History of Changes
Other Study ID Numbers: IBD 09-039
Study First Received: January 29, 2010
Last Updated: April 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
genetic screening

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014