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.
Verified January 2013 by Pennington Biomedical Research Center
Sponsor:
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01775176
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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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:
MedlinePlus related topics:
Diabetes Medicines
Exercise and Physical Fitness
Polycystic Ovary Syndrome
U.S. FDA Resources
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 2014 |
| Estimated Primary Completion Date: | August 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775176
Contacts
| Contact: Elizabeth A Frost, B.S. | 225-763-2794 | elizabeth.frost@pbrc.edu |
Locations
| United States, Louisiana | |
| Pennington Biomedical Research Center | Recruiting |
| Baton Rouge, Louisiana, United States, 70808 | |
| Contact: Elizabeth A Frost, B.S. 225-763-2794 elizabeth.frost@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: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pennington Biomedical Research Center:
|
PCOS, Weight, Insulin Sensitivity, Reproductive Function |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Insulin Resistance Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders |
Endocrine System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013