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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
First received: January 22, 2013
Last updated: May 17, 2016
Last verified: May 2016
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 Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Behavioral: Exercise
Behavioral: Dietary Restriction
Phase 3

Study Type: Interventional
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'

Resource links provided by NLM:

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 52
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Enrolled in PULSE

Exclusion Criteria:

  • Withdraw from PULSE
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01775176

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
  More Information

Responsible Party: Leanne Redman, Principle Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01775176     History of Changes
Other Study ID Numbers: PBRC 11016-A 
Study First Received: January 22, 2013
Last Updated: May 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
PCOS, Weight, Insulin Sensitivity, Reproductive Function

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Metabolic Diseases
Ovarian Cysts
Ovarian Diseases
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016