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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01775176
First received: January 22, 2013
Last updated: October 7, 2016
Last verified: October 2016
  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 ]

Enrollment: 16
Study Start Date: May 2012
Study Completion Date: April 2016
Primary Completion Date: April 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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
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

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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: October 7, 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:
Syndrome
Polycystic Ovary Syndrome
Hypersensitivity
Insulin Resistance
Disease
Pathologic Processes
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 08, 2016