Trial Outcomes & Findings for Genetic Testing for Type 2 Diabetes (NCT NCT01060540)
NCT ID: NCT01060540
Last Updated: 2015-04-24
Results Overview
weight 3 months post-enrollment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
601 participants
Primary outcome timeframe
3 months
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
298
|
|
Overall Study
COMPLETED
|
239
|
233
|
|
Overall Study
NOT COMPLETED
|
64
|
65
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
20
|
|
Overall Study
Lost to Follow-up
|
52
|
43
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Genetic Testing for Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
CR+G
n=303 Participants
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
|
CR+EYE
n=298 Participants
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
54.4 years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
54.1 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
248 Participants
n=99 Participants
|
235 Participants
n=107 Participants
|
483 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
137 participants
n=99 Participants
|
115 participants
n=107 Participants
|
252 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
166 participants
n=99 Participants
|
183 participants
n=107 Participants
|
349 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
303 participants
n=99 Participants
|
298 participants
n=107 Participants
|
601 participants
n=206 Participants
|
|
Education
High school graduate or less
|
82 participants
n=99 Participants
|
72 participants
n=107 Participants
|
154 participants
n=206 Participants
|
|
Education
Some post-high school education
|
221 participants
n=99 Participants
|
226 participants
n=107 Participants
|
447 participants
n=206 Participants
|
|
Weight
|
103.8 kg
STANDARD_DEVIATION 17.7 • n=99 Participants
|
100.7 kg
STANDARD_DEVIATION 18.9 • n=107 Participants
|
101.8 kg
STANDARD_DEVIATION 18.3 • n=206 Participants
|
|
Body mass index (BMI) stratification
BMI >= 35 kg/m^2
|
95 participants
n=99 Participants
|
85 participants
n=107 Participants
|
180 participants
n=206 Participants
|
|
Body mass index (BMI) stratification
BMI<35 kg/m^2
|
208 participants
n=99 Participants
|
213 participants
n=107 Participants
|
421 participants
n=206 Participants
|
|
Family history risk
high
|
79 participants
n=99 Participants
|
60 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Family history risk
moderate
|
79 participants
n=99 Participants
|
94 participants
n=107 Participants
|
173 participants
n=206 Participants
|
|
Family history risk
low
|
141 participants
n=99 Participants
|
140 participants
n=107 Participants
|
281 participants
n=206 Participants
|
|
Family history risk
unknown
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Lifetime risk
high
|
213 participants
n=99 Participants
|
193 participants
n=107 Participants
|
406 participants
n=206 Participants
|
|
Lifetime risk
moderate
|
81 participants
n=99 Participants
|
99 participants
n=107 Participants
|
180 participants
n=206 Participants
|
|
Lifetime risk
low
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Lifetime risk
unknown
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Genetic risk
high
|
74 participants
n=99 Participants
|
NA participants
n=107 Participants
|
NA participants
n=206 Participants
|
|
Genetic risk
moderate
|
113 participants
n=99 Participants
|
NA participants
n=107 Participants
|
NA participants
n=206 Participants
|
|
Genetic risk
low
|
114 participants
n=99 Participants
|
NA participants
n=107 Participants
|
NA participants
n=206 Participants
|
|
Genetic risk
unknown
|
2 participants
n=99 Participants
|
NA participants
n=107 Participants
|
NA participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsweight 3 months post-enrollment
Outcome measures
| Measure |
CR+G
n=303 Participants
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11
|
CR+EYE
n=298 Participants
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.
|
|---|---|---|
|
Weight
|
103.8 kg
Standard Deviation 17.7
|
100.7 kg
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 3 monthsCalculated 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.
Outcome measures
| Measure |
CR+G
n=303 Participants
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11
|
CR+EYE
n=298 Participants
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.
|
|---|---|---|
|
Insulin Resistance (HOMA2-IR)
|
4.1 units on a scale
Standard Deviation 3.6
|
4.1 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 3 monthsmeasured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)
Outcome measures
| Measure |
CR+G
n=303 Participants
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11
|
CR+EYE
n=298 Participants
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.
|
|---|---|---|
|
Perceived Lifetime Risk of Type 2 Diabetes
|
3.1 units on a scale
Standard Deviation 1.6
|
3.1 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 3 monthsEstimated 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
Outcome measures
| Measure |
CR+G
n=303 Participants
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11
|
CR+EYE
n=298 Participants
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.
|
|---|---|---|
|
Daily Caloric Intake
|
1487 kcal
Standard Deviation 1127
|
1573 kcal
Standard Deviation 894
|
SECONDARY outcome
Timeframe: 3 monthsself-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).
Outcome measures
| Measure |
CR+G
n=303 Participants
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing
genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11
|
CR+EYE
n=298 Participants
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.
|
|---|---|---|
|
Moderate Intensity Physical Activity
|
568 minutes per week
Standard Deviation 650
|
633 minutes per week
Standard Deviation 794
|
Adverse Events
CR+G
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
CR+EYE
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CR+G
n=303 participants at risk
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
|
CR+EYE
n=298 participants at risk
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
|
|---|---|---|
|
General disorders
Participant Death
|
0.33%
1/303 • Number of events 1
|
0.34%
1/298 • Number of events 1
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/303
|
0.34%
1/298 • Number of events 1
|
Other adverse events
| Measure |
CR+G
n=303 participants at risk
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
|
CR+EYE
n=298 participants at risk
conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
|
|---|---|---|
|
General disorders
Syncope
|
0.00%
0/303
|
0.34%
1/298 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place