NCT00315146

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

December 19, 2014

Completed
Last Updated

August 28, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

April 13, 2006

Results QC Date

March 7, 2013

Last Update Submit

July 30, 2018

Conditions

ObesityOverweight With Indications for Weight Loss

Keywords

Body CompositionSarcopeniaWeight loss trialsIntervention studiesElderly

Outcome Measures

Primary Outcomes (1)

  • Appendicular Non-bone Lean Mass

    Change in Appendicular Non-bone Lean Mass

    Baseline visit (pre intervention) and 4month follow up (post intervention)

Secondary Outcomes (1)

  • Lean Body Mass

    Baseline visit (pre intervention) and 4month follow up (post intervention)

Study Arms (4)

Hypocaloric diet (and placebo)

PLACEBO COMPARATOR
Behavioral: Hypocaloric dietDrug: Placebo

Hypocaloric diet, resist. training to maximize power, placebo

ACTIVE COMPARATOR
Behavioral: Resistance exercise training to maximize muscle powerBehavioral: Hypocaloric dietDrug: Placebo

Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™)

ACTIVE COMPARATOR
Drug: PioglitazoneBehavioral: Hypocaloric diet

Hypocaloric diet,resistance training, pioglitazone/Actos™

ACTIVE COMPARATOR
Drug: PioglitazoneBehavioral: Resistance exercise training to maximize muscle powerBehavioral: Hypocaloric diet

Interventions

PioglitazoneDRUG
Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™)Hypocaloric diet,resistance training, pioglitazone/Actos™
Resistance exercise training to maximize muscle powerBEHAVIORAL
Hypocaloric diet, resist. training to maximize power, placeboHypocaloric diet,resistance training, pioglitazone/Actos™
Hypocaloric dietBEHAVIORAL
Hypocaloric diet (and placebo)Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™)Hypocaloric diet, resist. training to maximize power, placeboHypocaloric diet,resistance training, pioglitazone/Actos™
PlaceboDRUG
Hypocaloric diet (and placebo)Hypocaloric diet, resist. training to maximize power, placebo

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Weight Stable, Indication for weight loss per NIH guidelines, Performance on the short physical performance battery score 3-10

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sticht Center on Aging, Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

ObesitySarcopenia

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Stephen Kritchevsky
Organization
Wake Forest Universtiy Baptist Medical Center
skritche@wakehealth.edu
336-713-8548

Study Officials

  • Stephen B Kritchevsky, PhD

    Sticht Center on Aging, Wake Forest University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

April 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 28, 2018

Results First Posted

December 19, 2014

Record last verified: 2018-07

Locations

US(1)