CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 88 enrolled
Drug / intervention
Pioglitazone +3 moredrug
Likely dose
Pioglitazone dose not specified in trial recordAI-extracted
Key inclusion· 2
  • Weight stable with indication for weight loss per NIH guidelines
  • Short physical performance battery score between 3 and 10 (indicating functional limitation)
Key exclusion· 12
  • Diabetes mellitus
  • Weight exceeding 136 kg
  • Medical condition that limits exercise participation
  • Congestive heart failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00315146
NCT00315146Phase 4Completed

Optimizing Body Composition for Function in Older Adults (OPTIMA) - A Pepper Pilot Study

Wake Forest University Health Sciences·interventional·Posted Apr 17, 2006·Updated Aug 28, 2018

In Brief

A Phase 4 clinical trial evaluating Pioglitazone, Resistance exercise training to maximize muscle power, and 2 other interventions for Obesity and Overweight With Indications for Weight Loss. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2006
Enrollment StartApr 1, 2006
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.2 years ago

Interventions

Pioglitazonedrug

Resistance exercise training to maximize muscle powerbehavioral

Hypocaloric dietbehavioral

Placebodrug