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

This study has been completed.
Sponsor:
Collaborator:
deCODE genetics
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00849563
First received: February 22, 2009
Last updated: April 9, 2014
Last verified: April 2014

February 22, 2009
April 9, 2014
April 2009
September 2011   (final data collection date for primary outcome measure)
Percentage of weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00849563 on ClinicalTrials.gov Archive Site
  • Change in perceptions of personal risk for Type 2 diabetes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Diabetes Mellitus, Type 2
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.
  • 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
    Intervention: Other: Standardized Risk Assessment
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
June 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00849563
Pro00011592
No
Duke University
Duke University
deCODE genetics
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
Duke University
April 2014

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