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
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Standardized Risk Assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Percentage of weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 450
Study Start Date: April 2009
Study Completion Date: June 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849563

Locations
United States, North Carolina
Duke Health Center at Pickett Rd
Durham, North Carolina, United States, 27705
Duke Family Medicine at Pickens
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
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
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00849563     History of Changes
Other Study ID Numbers: Pro00011592
Study First Received: February 22, 2009
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
predictive genomics
personalized medicine
personal genomics
genetic knowledge
genetic attitudes
prevention
health outcomes
behavioral

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

ClinicalTrials.gov processed this record on September 22, 2014