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 COMPLETED	239	233
Overall Study NOT COMPLETED	64	65
Overall Study STARTED	303	298

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=93 Participants	54.4 years STANDARD_DEVIATION 8.4 • n=4 Participants	54.1 years STANDARD_DEVIATION 8.7 • n=27 Participants
Sex: Female, Male Female	55 Participants n=93 Participants	63 Participants n=4 Participants	118 Participants n=27 Participants
Sex: Female, Male Male	248 Participants n=93 Participants	235 Participants n=4 Participants	483 Participants n=27 Participants
Race/Ethnicity, Customized Non-Hispanic White	137 participants n=93 Participants	115 participants n=4 Participants	252 participants n=27 Participants
Race/Ethnicity, Customized Other	166 participants n=93 Participants	183 participants n=4 Participants	349 participants n=27 Participants
Region of Enrollment United States	303 participants n=93 Participants	298 participants n=4 Participants	601 participants n=27 Participants
Education High school graduate or less	82 participants n=93 Participants	72 participants n=4 Participants	154 participants n=27 Participants
Education Some post-high school education	221 participants n=93 Participants	226 participants n=4 Participants	447 participants n=27 Participants
Weight	103.8 kg STANDARD_DEVIATION 17.7 • n=93 Participants	100.7 kg STANDARD_DEVIATION 18.9 • n=4 Participants	101.8 kg STANDARD_DEVIATION 18.3 • n=27 Participants
Body mass index (BMI) stratification BMI >= 35 kg/m^2	95 participants n=93 Participants	85 participants n=4 Participants	180 participants n=27 Participants
Body mass index (BMI) stratification BMI<35 kg/m^2	208 participants n=93 Participants	213 participants n=4 Participants	421 participants n=27 Participants
Family history risk high	79 participants n=93 Participants	60 participants n=4 Participants	139 participants n=27 Participants
Family history risk moderate	79 participants n=93 Participants	94 participants n=4 Participants	173 participants n=27 Participants
Family history risk low	141 participants n=93 Participants	140 participants n=4 Participants	281 participants n=27 Participants
Family history risk unknown	4 participants n=93 Participants	4 participants n=4 Participants	8 participants n=27 Participants
Lifetime risk high	213 participants n=93 Participants	193 participants n=4 Participants	406 participants n=27 Participants
Lifetime risk moderate	81 participants n=93 Participants	99 participants n=4 Participants	180 participants n=27 Participants
Lifetime risk low	8 participants n=93 Participants	5 participants n=4 Participants	13 participants n=27 Participants
Lifetime risk unknown	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Genetic risk high	74 participants n=93 Participants	NA participants n=4 Participants	NA participants n=27 Participants
Genetic risk moderate	113 participants n=93 Participants	NA participants n=4 Participants	NA participants n=27 Participants
Genetic risk low	114 participants n=93 Participants	NA participants n=4 Participants	NA participants n=27 Participants
Genetic risk unknown	2 participants n=93 Participants	NA participants n=4 Participants	NA participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months

weight 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 months

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.

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 months

measured 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 months

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

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 months

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).

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

Corrine Voils, PhD

Durham VA Medical Center

Phone: 919-286-0411

Email: corrine.voils@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place