Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome:Studies in Skeletal Muscle and Adipose Tissue (PULSE-A)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01775176
First received: January 22, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Metformin Drug: Metformin
Experimental: Dietary Restriction Behavioral: Dietary Restriction
Experimental: Exercise 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.

  Eligibility

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

Inclusion Criteria:

  • Enrolled in PULSE

Exclusion Criteria:

  • Withdraw from PULSE
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775176

Contacts
Contact: Erin Lejeune, B.S. 225-763-2706 erin.lejeune@pbrc.edu

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Erin Lejeune, B.S.    225-763-2706    erin.lejeune@pbrc.edu   
Principal Investigator: Leanne M Redman, Ph.D.         
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Leanne Redman, Principle Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01775176     History of Changes
Other Study ID Numbers: PBRC11016-A
Study First Received: January 22, 2013
Last Updated: August 11, 2014
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
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Insulin
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014