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

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ClinicalTrials.gov Identifier: NCT01775176
Recruitment Status : Terminated (Parent Study stopped due to poor recruitment and enrollment)
First Posted : January 24, 2013
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

Brief Summary:
The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286).

Condition or disease
Polycystic Ovary Syndrome

Detailed Description:
Muscle and adipose tissues will be appropriately collected and banked for future studies such as to measure expression of candidate genes involved with carbohydrate and fat oxidation and mitochondrial function by RT-PCR, protein content by western blot, enzyme activity by enzymatic assays and to perform functional studies under varying conditions (for example before and after treatment with insulin, testosterone, serum) to quantify insulin signaling and carbohydrate and fat oxidation in primary human cultures.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
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'
Actual 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

Drug Information available for: Insulin

Group/Cohort
Polycystic Ovary Syndrome
Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusiveBody mass index ≥ 25kg/m2History of irregular menstrual cycles (fewer than 8 regular cycles in the past year)Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8)Anovulatory menstrual cycles (determined during screening)



Primary Outcome Measures :
  1. Bio specimens for future research [ Time Frame: 10 years ]

Biospecimen Retention:   Samples Without DNA
Skeletal Muscle Subcutaneous Adipose Tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Overweight women with polycystic ovary syndrome.

20 - 40 years, inclusive Body mass index ≥ 25kg/m2 History of irregular menstrual cycles (fewer than 8 regular cycles in the past year) Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8) Anovulatory menstrual cycles (determined during screening)

Criteria

Inclusion Criteria:

  • Enrolled in PULSE NCT01482286

Exclusion Criteria:

  • Withdraw from PULSE NCT01482286

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 ClinicalTrials.gov identifier (NCT number): NCT01775176


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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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
ClinicalTrials.gov Identifier: NCT01775176    
Other Study ID Numbers: PBRC 11016-A
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Hypersensitivity
Syndrome
Disease
Pathologic Processes
Immune System Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases