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Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose (PULSE-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775176
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : October 28, 2019
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Behavioral: Exercise Behavioral: Dietary Restriction Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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'
Study Start Date : May 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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: Metformin
1000mg BID
Drug: Metformin
Experimental: Dietary Restriction
25% dietary restriction
Behavioral: Dietary Restriction
Experimental: Exercise
10 kcal/kg/week in exercise energy expenditure. 3 x resistance training sessions per week (8 exercises)
Behavioral: Exercise

Primary Outcome Measures :
  1. Change in skeletal muscle insulin resistance Pulsatility profile of Luteinizing Hormone (LH) [ Time Frame: Baseline, week 24 ]
  2. Change in adipose tissue insulin resistance [ Time Frame: Baseline, week 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Enrolled in PULSE

Exclusion Criteria:

  • Withdraw from PULSE

Information from the National Library of Medicine

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 identifier (NCT number): NCT01775176

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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
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Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
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Responsible Party: Leanne Redman, Principle Investigator, Pennington Biomedical Research Center Identifier: NCT01775176    
Other Study ID Numbers: PBRC 11016-A
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
PCOS, Weight, Insulin Sensitivity, Reproductive Function
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Pathologic Processes
Immune System Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs