Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose (PULSE-A)
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|ClinicalTrials.gov Identifier: NCT01775176|
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Metformin Behavioral: Exercise Behavioral: Dietary Restriction||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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'|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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)
- Change in skeletal muscle insulin resistance Pulsatility profile of Luteinizing Hormone (LH) [ Time Frame: Baseline, week 24 ]
- Change in adipose tissue insulin resistance [ Time Frame: Baseline, week 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775176
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Leanne M Redman, Ph.D.||Pennington Biomedical Research Center|