N/A
N=601
Genetic Testing for Type 2 Diabetes
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01060540 ↗Enrolled (actual)
601
Serious AEs
0.5%
Results posted
Aug 2014
Primary outcome: Primary: Weight — 103.8; 100.7 kg — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- genetic testing for type 2 diabetes (Genetic); Conventional risk counseling (Behavioral); eye disease counseling (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
103.8; 100.7 | 0.44 |
| SECONDARY Insulin Resistance (HOMA2-IR) |
4.1; 4.1 | 0.19 |
| SECONDARY Perceived Lifetime Risk of Type 2 Diabetes |
3.1; 3.1 | 0.38 |
| SECONDARY Daily Caloric Intake |
1487; 1573 | 0.05 |
| SECONDARY Moderate Intensity Physical Activity |
568; 633 | 0.68 |
Summary
In this 6-month randomized, controlled trial, we examined whether providing participants with genetic test results and counseling regarding their risk for type 2 diabetes would motivate them to improve their health behaviors and lose weight to reduce their diabetes risk. We hypothesized that participants who received conventional diabetes counseling plus genetic test results and counseling would have at least 6 lb greater weight loss at 3 months than participants who received conventional diabetes counseling without genetic test results.
Eligibility Criteria
Inclusion Criteria
- body mass index >27 kg/m2
- baseline fasting plasma glucose 125 mg/dL on more than one occasion
- HbA1c > 7%
- taking diabetes medication
- actively losing weight
- enrolled in research study focusing on lifestyle changes
- unable to provide informed consent or answer survey questions unassisted
- residing in nursing home or receiving home health care
- active diagnosis of psychosis or dementia
- at least one error on 6-item cognitive screener
Data sourced from ClinicalTrials.gov (NCT01060540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.