Phase 2
N=58
A Lifestyle Change Program to Prevent Type 2 Diabetes
Prediabetes
Bottom Line
View on ClinicalTrials.gov: NCT00886340 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Apr 2009
Primary outcome: Primary: Number of Participants Who Met Weight Loss Goal of 5% Weight Loss — 3; 6 participants — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Enhanced standard care (Behavioral); Lifestyle counseling (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Met Weight Loss Goal of 5% Weight Loss |
3; 6 | 0.08 |
| SECONDARY Diet and Exercise Behavior |
— | — |
| SECONDARY Lipids |
— | — |
| SECONDARY Quality of Life |
— | — |
Summary
The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.
Eligibility Criteria
Inclusion Criteria
- age 21 or older
- medically stable and safe to exercise
- at high risk for type 2 diabetes
- able to speak English.
Exclusion Criteria
- Type 2 diabetes
- Cardiovascular disease
- Cancer requiring treatment in the past 5 years
- Anemia
- Hepatitis
- Renal disease
- Gastrointestinal disease
- Recent or significant abdominal surgery
- Pulmonary disease with dependence on oxygen or daily use of bronchodilators
- Chronic infection (ie., HIV, active tuberculosis)
- Unable to walk 0.25 miles in 10 minutes
- Participation in commercial diet program
- Currently pregnant or within 3 months postpartum
- Currently nursing or within 6 weeks of having completed nursing
- Treatment of impaired glucose tolerance (IGT) with metformin
- Currently taking any glucocorticoid or beta-blocker
- Recently prescribed or changed dose of a statin (within 2 months)
Data sourced from ClinicalTrials.gov (NCT00886340). 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.