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Diabetes MellitusNCT01060540

Genetic Testing for Type 2 Diabetes

A study testing genetic testing for type 2 diabetes, Conventional risk counseling and eye disease counseling in people with Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
genetic testing for type 2 diabetes, Conventional risk counseling and eye disease counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
601 participants
Where
1 siteUnited States
Study dates
Aug 2010to Mar 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
genetic testing for type 2 diabetes, Conventional risk counseling, eye disease counseling
Keywords
genetic screening
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • genetic testing for type 2 diabetesGenetic

    TCF7L2, PPARG, or KCNJ11

  • Conventional risk counselingBehavioural

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

  • eye disease counselingBehavioural

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

Study groups in NCT01060540
Study groupRoleWhat they receive
CR+GExperimentalconventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
Receives: Genetic: genetic testing for type 2 diabetes; Behavioral: Conventional risk counseling
CR+EYEActive comparatorconventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
Receives: Behavioral: Conventional risk counseling; Behavioral: eye disease counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    weight 3 months post-enrollment

    Measured: 3 months

Secondary outcomes (4)

  1. Insulin Resistance (HOMA2-IR)

    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.

    Measured: 3 months

  2. Perceived Lifetime Risk of Type 2 Diabetes

    measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)

    Measured: 3 months

  3. Daily Caloric Intake

    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

    Measured: 3 months

  4. Moderate Intensity Physical Activity

    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).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01060540
Sponsor's protocol ID
IBD 09-039
Status last verified
Apr 2014
First submitted
29 Jan 2010
Last updated
24 Apr 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 29776196

  • 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.

    PubMed 22852560

  • 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.

    PubMed 25876740

  • 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. doi: 10.1007/s10897-012-9486-x.

    PubMed 22302620

Questions about this trial

What is this clinical trial studying?

A study testing genetic testing for type 2 diabetes, Conventional risk counseling and eye disease counseling in people with Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01060540, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015; AzTrials last refreshed its copy on 28 Oct 2026.

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