Genetic Testing for Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT01060540
• Recruitment Status: Completed
• First Posted: February 2, 2010
• Results First Posted: August 4, 2014
• Last Update Posted: April 24, 2015
• Sponsor: US Department of Veterans Affairs
• Collaborator: Duke University
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus	Genetic: genetic testing for type 2 diabetes; Behavioral: Conventional risk counseling; Behavioral: eye disease counseling	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 601 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Impact of Genetic Testing for Type 2 Diabetes on Health Behaviors
• Study Start Date: August 2010
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: CR+G; conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes	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.
Active Comparator: CR+EYE; conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling	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

Outcome Measures

Primary Outcome Measures :

1. Weight [ Time Frame: 3 months ]
   weight 3 months post-enrollment

Secondary Outcome Measures :

1. Insulin Resistance (HOMA2-IR) [ Time Frame: 3 months ]

   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.

2. Perceived Lifetime Risk of Type 2 Diabetes [ Time Frame: 3 months ]
   measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)
3. Daily Caloric Intake [ Time Frame: 3 months ]
   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
4. Moderate Intensity Physical Activity [ Time Frame: 3 months ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, North Carolina

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

US Department of Veterans Affairs

Duke University

Investigators

• Principal Investigator: Corrine I. Voils, PhD; Durham VA Medical Center, Durham, NC

More Information

Publications of Results:

Vorderstrasse AA, Cho A, Voils CI, Orlando LA, Ginsburg GS. Clinical utility of genetic risk testing in primary care: the example of Type 2 diabetes. Per Med. 2013 Aug;10(6):549-563. doi: 10.2217/pme.13.47.

Voils CI, Coffman CJ, Edelman D, Maciejewski ML, Grubber JM, Sadeghpour A, Cho A, McKenzie J, Blanpain F, Scheuner M, Sandelowski M, Gallagher MP, Ginsburg GS, Yancy WS Jr. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:121. doi: 10.1186/1745-6215-13-121.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Voils CI, Coffman CJ, Grubber JM, Edelman D, Sadeghpour A, Maciejewski ML, Bolton J, Cho A, Ginsburg GS, Yancy WS Jr. Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans. J Gen Intern Med. 2015 Nov;30(11):1591-8. doi: 10.1007/s11606-015-3315-5. Epub 2015 Apr 16.

Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT01060540
• Other Study ID Numbers: IBD 09-039
• First Posted: February 2, 2010
• Results First Posted: August 4, 2014
• Last Update Posted: April 24, 2015
• Last Verified: April 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

genetic screening

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases