Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome:Studies in Skeletal Muscle and Adipose Tissue (PULSE-A)
The purpose of the study is to test in 52 overweight and obese women with polycystic ovary syndrome the effect of 6 months of treatment with either: exercise training, 25% dietary restriction or metformin in comparison to a control group receiving no intervention on the functions of the skeletal muscle and adipose tissue.
Polycystic Ovary Syndrome
Behavioral: Dietary Restriction
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome: Studies in Skeletal Muscle and Adipose Tissue 'PULSE Ancillary Study'|
- Change in skeletal muscle insulin resistance Pulsatility profile of Luteinizing Hormone (LH) [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
- Change in adipose tissue insulin resistance [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
No Intervention: Control
Control subjects recieve no intervention for diet, exercise or metformin and are asked to adhere to usual behaviors throughout the trial.
Experimental: Dietary Restriction
25% dietary restriction
|Behavioral: Dietary Restriction|
10 kcal/kg/week in exercise energy expenditure. 3 x resistance training sessions per week (8 exercises)
The PULSE Ancillary study will last about 7 months. Participants will one or two additional procedures performed at baseline and during the week 24 testing.
These procedures include a fat biopsy, a muscle biopsy or both.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775176
|Contact: Erin Lejeune, B.S.||email@example.com|
|United States, Louisiana|
|Pennington Biomedical Research Center||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Contact: Erin Lejeune, B.S. 225-763-2706 firstname.lastname@example.org|
|Principal Investigator: Leanne M Redman, Ph.D.|
|Principal Investigator:||Leanne M Redman, Ph.D.||Pennington Biomedical Research Center|