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Trial record 7 of 8 for:    KCNJ11

Genetic Testing for Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01060540
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : August 4, 2014
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Diabetes Mellitus
Interventions Genetic: genetic testing for type 2 diabetes
Behavioral: Conventional risk counseling
Behavioral: eye disease counseling
Enrollment 601
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CR+G CR+EYE
Hide Arm/Group Description

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

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

eye disease counseling

Period Title: Overall Study
Started 303 298
Completed 239 233
Not Completed 64 65
Reason Not Completed
Withdrawal by Subject             10             20
Lost to Follow-up             52             43
Death             2             1
Physician Decision             0             1
Arm/Group Title CR+G CR+EYE Total
Hide Arm/Group Description conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling Total of all reporting groups
Overall Number of Baseline Participants 303 298 601
Hide Baseline Analysis Population Description
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).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 303 participants 298 participants 601 participants
53.9  (9.1) 54.4  (8.4) 54.1  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 298 participants 601 participants
Female
55
  18.2%
63
  21.1%
118
  19.6%
Male
248
  81.8%
235
  78.9%
483
  80.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 298 participants 601 participants
Non-Hispanic White 137 115 252
Other 166 183 349
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 303 participants 298 participants 601 participants
303 298 601
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 298 participants 601 participants
High school graduate or less 82 72 154
Some post-high school education 221 226 447
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 303 participants 298 participants 601 participants
103.8  (17.7) 100.7  (18.9) 101.8  (18.3)
Body mass index (BMI) stratification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 298 participants 601 participants
BMI >= 35 kg/m^2 95 85 180
BMI<35 kg/m^2 208 213 421
Family history risk  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 298 participants 601 participants
high 79 60 139
moderate 79 94 173
low 141 140 281
unknown 4 4 8
Lifetime risk  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 298 participants 601 participants
high 213 193 406
moderate 81 99 180
low 8 5 13
unknown 1 1 2
Genetic risk  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 303 participants 298 participants 601 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.
1.Primary Outcome
Title Weight
Hide Description weight 3 months post-enrollment
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR+G CR+EYE
Hide Arm/Group Description:

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing

genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling

Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history.

Overall Number of Participants Analyzed 303 298
Mean (Standard Deviation)
Unit of Measure: kg
103.8  (17.7) 100.7  (18.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CR+G, CR+EYE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted for family history (low/unknown vs. high/moderate) and BMI>=35 (yes vs no) stratification variables
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.3 to 0.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Insulin Resistance (HOMA2-IR)
Hide Description

Calculated using the updated homeostasis model assessment (HOMA) calculator at http://www.dtu.ox.ac.uk/homacalculator/

Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR+G CR+EYE
Hide Arm/Group Description:

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing

genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling

Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history.

Overall Number of Participants Analyzed 303 298
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.1  (3.6) 4.1  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CR+G, CR+EYE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments adjusted for baseline BMI class and family history level stratification variables
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Perceived Lifetime Risk of Type 2 Diabetes
Hide Description measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR+G CR+EYE
Hide Arm/Group Description:

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing

genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling

Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history.

Overall Number of Participants Analyzed 303 298
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.1  (1.6) 3.1  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CR+G, CR+EYE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments adjusted for stratification variables baseline BMI and family history
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Daily Caloric Intake
Hide Description Estimated daily caloric intake based on self-reported frequency and amount of intake of specific foods over the past 3 months as assessed by the Block Brief Food Frequency Questionnaire
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR+G CR+EYE
Hide Arm/Group Description:

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing

genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11

conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling

Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history.

Overall Number of Participants Analyzed 303 298
Mean (Standard Deviation)
Unit of Measure: kcal
1487  (1127) 1573  (894)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CR+G, CR+EYE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments adjusted for baseline family history and BMI
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Moderate Intensity Physical Activity
Hide Description self-report based on the long version of the International Physical Activity Questionnaire. Moderate physical activity was queried in the domains of work (e.g., carrying light loads), transportation (e.g., bicycling), domestic chores and gardening (e.g., sweeping, raking), and leisure-time (e.g., bicycling, swimming).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR+G CR+EYE
Hide Arm/Group Description:
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
Overall Number of Participants Analyzed 303 298
Mean (Standard Deviation)
Unit of Measure: minutes per week
568  (650) 633  (794)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CR+G, CR+EYE
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments adjusted for baseline family history and BMI
Method generalized linear model for count data
Comments [Not Specified]
Method of Estimation Estimation Parameter incident rate ratio
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.7 to 1.2
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CR+G CR+EYE
Hide Arm/Group Description conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
All-Cause Mortality
CR+G CR+EYE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CR+G CR+EYE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/303 (0.33%)      2/298 (0.67%)    
Cardiac disorders     
Heart Attack * [1]  0/303 (0.00%)  0 1/298 (0.34%)  1
General disorders     
Participant Death * [2]  1/303 (0.33%)  1 1/298 (0.34%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant had a heart attack and had a stent place. He was hospitalized for 4 days and sent home.
[2]
Participant passed away as noticed in their electronic medical record as noted when trying to schedule a follow-up appointment. No cause was given.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CR+G CR+EYE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/303 (0.00%)      1/298 (0.34%)    
General disorders     
Syncope * [1]  0/303 (0.00%)  0 1/298 (0.34%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant fainted during a blood draw at the lab.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Corrine Voils, PhD
Organization: Durham VA Medical Center
Phone: 919-286-0411 ext 5196
EMail: corrine.voils@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01060540     History of Changes
Other Study ID Numbers: IBD 09-039
First Submitted: January 29, 2010
First Posted: February 2, 2010
Results First Submitted: April 16, 2014
Results First Posted: August 4, 2014
Last Update Posted: April 24, 2015