Phase 3
N=302
Enhancing Fitness in Older Pre-diabetic Veterans
Impaired Glucose Tolerance · Obesity · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00594399 ↗Enrolled (actual)
302
Serious AEs
12.3%
Results posted
Jan 2015
Primary outcome: Primary: Fasting Insulin — 10.26; 10.39 uIU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Physical Activity Counseling (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Insulin |
10.26; 10.39 | — |
| PRIMARY 3 Month Fasting Insulin |
10.04; 10.45 | — |
| PRIMARY 12 Month Fasting Insulin |
11.4; 10.28 | 0.43 |
| PRIMARY Fasting Glucose |
110.51; 110.6 | — |
| PRIMARY 3 Month Fasting Glucose |
106.96; 107.63 | — |
| PRIMARY 12 Month Fasting Glucose |
104.35; 104.38 | 0.91 |
| SECONDARY Physical Activity, Endurance |
133.6; 112.62 | <0.001 sig |
| SECONDARY Physical Activity, Endurance |
133.6; 112.62 | <0.001 sig |
| SECONDARY Physical Activity, Endurance |
133.6; 112.62 | <0.001 sig |
Summary
This study targets older adults (ages 60 and over) who are overweight (body mass index 25-40) with impaired fasting glucose (100 - 125). We propose a three-year, randomized controlled clinical trial (n=300) to determine the effect of a one-year physical activity counseling intervention on glucose metabolism and secondary outcomes compared to usual care.
Eligibility Criteria
Inclusion Criteria
- VA patients followed by the Durham VA Primary Care, Women's Health, and Geriatric clinics
- Must have had more than one visit to the VA in preceding 12 months
- Age 60 and over
- Impaired glucose intolerance documented by recent fasting blood glucose between 100 and 125 mg/dL
- Body mass index between 25-40 kg/m2
- Able to walk 10 meters without human assistance (assistive device acceptable)
- All participants must be assigned a primary care provider and have had more than one visit to the VA in the preceding 12 months
Exclusion Criteria
- Free of frank diabetes
- Fasting blood sugar above 125 mg/dL
- HbA1c > 7%
- Unstable angina
- Recent history of ventricular tachycardia
- Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
- Uncontrolled hypertension (diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg)
- Stroke with moderate to severe aphasia
- Diagnosis of chronic pain which may interfere with their ability to be physically active
- Diagnosis of unstable mental or behavioral disorder
- Diagnosis of memory loss or dementia
- Visual or hearing loss severe enough to interfere with ability to receive telephone counseling and review written materials
- Active substance abuse
- A terminal diagnosis
- Followed by VA for medications only
- Regularly, vigorously physically active for six months or longer.
Data sourced from ClinicalTrials.gov (NCT00594399). 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.