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Genetic Testing for Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01060540
First received: January 29, 2010
Last updated: April 6, 2015
Last verified: April 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 
Overall Participants Analyzed 
[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 [1] [2] 
[Units: Participants]
     
high   74   NA [1]   NA [2] 
moderate   113   NA [1]   NA [2] 
low   114   NA [1]   NA [2] 
unknown   2   NA [1]   NA [2] 
[1] not tested
[2] Total not calculated because data are not available (NA) in one or more arms.


  Outcome Measures
  Show All Outcome Measures

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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
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: April 6, 2015
Health Authority: United States: Federal Government