Genetic Testing for Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01060540
First received: January 29, 2010
Last updated: July 11, 2014
Last verified: July 2014
Results First Received: April 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Diabetes Mellitus
Interventions: Genetic: genetic testing for type 2 diabetes
Behavioral: Conventional risk counseling
Behavioral: eye disease counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CR+G

conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)

results of genetic testing for type 2 diabetes based on the genes TCF7L2, PPARG, or KCNJ11

CR+EYE

conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)

eye disease counseling


Participant Flow:   Overall Study
    CR+G     CR+EYE  
STARTED     303     298  
COMPLETED     239     233  
NOT COMPLETED     64     65  
Withdrawal by Subject                 10                 20  
Lost to Follow-up                 52                 43  
Death                 2                 1  
Physician Decision                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were calculated for all participants who attended the baseline session, where consent and baseline measures were obtained, regardless of whether they attended the intervention (risk counseling session).

Reporting Groups
  Description
CR+G conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
CR+EYE conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
Total Total of all reporting groups

Baseline Measures
    CR+G     CR+EYE     Total  
Number of Participants  
[units: participants]
  303     298     601  
Age  
[units: years]
Mean ± Standard Deviation
  53.9  ± 9.1     54.4  ± 8.4     54.1  ± 8.7  
Gender  
[units: participants]
     
Female     55     63     118  
Male     248     235     483  
Race/Ethnicity, Customized  
[units: participants]
     
Non-Hispanic White     137     115     252  
Other     166     183     349  
Region of Enrollment  
[units: participants]
     
United States     303     298     601  
Education  
[units: participants]
     
High school graduate or less     82     72     154  
Some post-high school education     221     226     447  
Weight  
[units: kg]
Mean ± Standard Deviation
  103.8  ± 17.7     100.7  ± 18.9     101.8  ± 18.3  
Body mass index (BMI) stratification  
[units: participants]
     
BMI >= 35 kg/m^2     95     85     180  
BMI<35 kg/m^2     208     213     421  
Family history risk  
[units: participants]
     
high     79     60     139  
moderate     79     94     173  
low     141     140     281  
unknown     4     4     8  
Lifetime risk  
[units: participants]
     
high     213     193     406  
moderate     81     99     180  
low     8     5     13  
unknown     1     1     2  
Genetic risk  
[units: participants]
     
high     74     NA [2]   NA [1]
moderate     113     NA [2]   NA [1]
low     114     NA [2]   NA [1]
unknown     2     NA [2]   NA [1]
[1] Total not calculated because data are not available (NA) in one or more arms.
[2] not tested



  Outcome Measures
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1.  Primary:   Weight   [ Time Frame: 3 months ]

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

3.  Secondary:   Perceived Lifetime Risk of Type 2 Diabetes   [ Time Frame: 3 months ]

4.  Secondary:   Daily Caloric Intake   [ Time Frame: 3 months ]

5.  Secondary:   Moderate Intensity Physical Activity   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Corrine Voils, PhD
Organization: Durham VA Medical Center
phone: 919-286-0411 ext 5196
e-mail: corrine.voils@va.gov


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01060540     History of Changes
Other Study ID Numbers: IBD 09-039
Study First Received: January 29, 2010
Results First Received: April 16, 2014
Last Updated: July 11, 2014
Health Authority: United States: Federal Government