Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes (TDE)

April 9, 2014 updated by: Duke University
The primary objective of the study is to assess the clinical utility of a genetic test for Type 2 diabetes risk in combination with standardized risk assessment compared with standardized risk assessment alone, and to measure whether changes in perceived risk following genetic testing for Type 2 diabetes risk are correlated with behavior change and increased concern about risk for Type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One thousand outpatients will be enrolled over two years at two university-affiliated primary care clinics. Patients will be assigned to one of three study arms: those who want genetic testing for diabetes risk will be randomly assigned to either receive the testing in addition to the SRA (SRA+G) or to receive the SRA only (SRA-only). Those who do not wish to have genetic testing will receive the SRA only. All patients will be surveyed at baseline, immediately after going through the SRA (risk-counseling visit; 2-4 weeks after initial visit), at 3 months post risk counseling visit and at 12 months post risk counseling visit. BMI, waist circumference, fasting plasma glucose and insulin will be measured at baseline and 12 months. Surveys will allow us to track patients' emotional responses to diabetes risk information and changing perceptions of personal risk for Type 2 diabetes over time, and to see if these correlate with subsequent diet and exercise behaviors.

We will use a linear model to assess the effects of genetic testing among the three study groups, using HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) and weight loss as the primary outcomes. We will use generalized linear ordinal regression models to fit the ordinal survey outcomes of risk perceptions to the continuous HOMA-IR and weight outcome variables.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Family Medicine at Pickens
      • Durham, North Carolina, United States, 27705
        • Duke Health Center at Pickett Rd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are male or female outpatients
  • No self-reported history of diabetes
  • No self-reported history of prior genetic testing for diabetes
  • Not pregnant (self report)
  • Are ≥18 and <81 years of age
  • Scheduled to receive serum glucose test in participating clinic
  • Fasting at time of blood draw (no food or drink - except water - previous 8 hours: self report)
  • Able and willing to give legally effective consent
  • Able and willing to participate in patient questionnaires
  • Ambulatory

Exclusion Criteria:

  • Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening
  • Self-report of current or prior diabetes diagnosis
  • Self-reported prior history of genetic testing for diabetes
  • Baseline serum glucose test result >125

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SRA+genetic test
patients randomized to receive genetic test for type 2 diabetes risk will be followed and surveyed and will be counseled based on SAR and genetic risk for type 2 diabetes
Other: Standardized Risk Assessment
patients interested in genetic testing will be randomly assigned to either get testing for type 2 diabetes or not. All arms with receive standardized risk asessements. This study is evaluating behavior after receipt of genetic risk information and different types of counseling.
No Intervention: SRA only
Patients randomized to not get genetic testing will be followed and surveyed and will be counseled based on SRA only
No Intervention: no testing control
Patients not interested in genetic testing will be followed and surveyed. Counseling will be based on SRA only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of weight loss
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in perceptions of personal risk for Type 2 diabetes
Time Frame: 12 months
12 months
Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

deCODE genetics

Investigators

  • Principal Investigator: Geoffrey Ginsburg, Md, PhD, Institute for Genome Sciences and Policy, Duke University
  • Principal Investigator: Alex Cho, MD, Institute for Genome Sciences and Policy, Duke University
  • Principal Investigator: Scott Joy, MD, Duke University
  • Principal Investigator: Susanne Haga, PhD, Institute for Genome Sciences and Policy, Duke University
  • Principal Investigator: Isaac Lipkus, PhD, Institute for Genome Sciences and Policy, Duke University
  • Principal Investigator: Gloria Trujillo, MD, Duke University
  • Principal Investigator: Julianne O'Daniel, PhD, Institute for Genome Sciences and Policy, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 22, 2009

First Submitted That Met QC Criteria

February 22, 2009

First Posted (Estimate)

February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00011592

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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