Phase 4
N=88
Optimizing Body Composition for Function in Older Adults
Obesity · Overweight With Indications for Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT00315146 ↗Enrolled (actual)
88
Serious AEs
3.4%
Results posted
Dec 2014
Primary outcome: Primary: Appendicular Non-bone Lean Mass — -2.53; -2.49; -2.04; -1.45 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pioglitazone (Drug); Resistance exercise training to maximize muscle power (Behavioral); Hypocaloric diet (Behavioral); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Appendicular Non-bone Lean Mass |
-2.53; -2.49; -2.04; -1.45 | — |
| SECONDARY Lean Body Mass |
-2.55; -1.89; -2.38; -1.65 | — |
Summary
The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These strategies will be used in conjunction with a hypocaloric diet and will be compared to a hypocaloric diet alone to determine if either of these strategies are superior in reducing visceral fat and preserving muscle mass.
Eligibility Criteria
Inclusion Criteria
- Weight Stable, Indication for weight loss per NIH guidelines, Performance on the short physical performance battery score 3-10
Exclusion Criteria
- Diabetes, weight > 136 kg, Medical condition that limits exercise participation, Congestive heart failure, abnormal kidney function, higher ALT than normal, currently involved in a weight loss or exercise program, current smoking, alcohol or drug abuse, taking anti-inflammatory steroids, taking protein supplements, taking PPAR-gamma agonist, edema, anemia
Data sourced from ClinicalTrials.gov (NCT00315146). 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.