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NCT01775176 Clinical Trial

Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose

Polycystic Ovary Syndrome Clinical Trial

— PULSE-A  

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'

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01775176
Other study ID # PBRC 11016-A
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 2012
Est. completion date April 2016

Study information
Verified date August 2021
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Enrolled in PULSE NCT01482286 Exclusion Criteria: - Withdraw from PULSE NCT01482286

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bio specimens for future research 10 years
See also
  Status Clinical Trial Phase
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Completed NCT06158932 - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04932070 - Berberine and Polycystic Ovary Syndrome N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03480022 - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS Phase 3
Active, not recruiting NCT03043924 - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT05246306 - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed NCT05981742 - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS Phase 2
Completed NCT05702957 - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome Phase 2/Phase 3
Completed NCT05029492 - Effect of Visceral Manipulation on PCOS N/A
Not yet recruiting NCT02255578 - Endobarrier Treatment in Women With PCOS Phase 3
Completed NCT02924025 - Motivational Interviewing as an Intervention for PCOS N/A
Completed NCT02098668 - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON N/A
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Completed NCT01462864 - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A