Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315146
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2006-04-13
Brief Title:
Optimizing Body Composition for Function in Older Adults
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Optimizing Body Composition for Function in Older Adults OPTIMA - A Pepper Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
In this pilot we propose to recruit 88 older 65 - 79 yrs men n48 and women n40 at risk for disability and with indications for weight loss according to NIH guidelines All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcalday for a 4 month period All will receive supplemental vitamin D and calcium These participants will be randomized into one of 4 groups
Group 1 - Hypocaloric diet and placebo Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power and placebo Group 3 - Hypocaloric diet and a PPAR- γ agonist pioglitazoneActos Group 4 - Hypocaloric diet and resistance training and pioglitazoneActos
The specific aims of the pilot are
1 In both men and women to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training
2 In both men and women to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group
3 Assess the feasibility of the recruitment assessment and intervention strategies
4 To estimate adherence to the weight loss exercise training and drug interventions
5 In this population to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study
6 To obtain pilot data on a subset of participants to determine the feasibility acceptability and measurement characteristics of muscle samples biopsies to quantify intramyocellular lipid in this study population
Group 1 - Hypocaloric diet and placebo Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power and placebo Group 3 - Hypocaloric diet and a PPAR- γ agonist pioglitazoneActos Group 4 - Hypocaloric diet and resistance training and pioglitazoneActos
The specific aims of the pilot are
1 In both men and women to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training
2 In both men and women to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group
3 Assess the feasibility of the recruitment assessment and intervention strategies
4 To estimate adherence to the weight loss exercise training and drug interventions
5 In this population to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study
6 To obtain pilot data on a subset of participants to determine the feasibility acceptability and measurement characteristics of muscle samples biopsies to quantify intramyocellular lipid in this study population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG021332 | NIH | None | httpsreporternihgovquickSearchP30AG021332 |