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NCT05592080 Clinical Trial

Exploring Liver and Muscle Fat Content Using MRI

Polycystic Ovary Syndrome Clinical Trial

Official title:
Exploring Liver and Muscle Fat Content in Overweight and Obese Polycystic Ovary Syndrome Using Magnetic Resonance Imaging Technique

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05592080
Other study ID # 2022PS1008K
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date June 1, 2022

Study information
Verified date October 2022
Source Shengjing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of our study was to compare the difference of fatty infiltration in liver and muscle using magnetic resonance imaging (MRI) between overweight as well as obese polycystic ovary syndrome (PCOS) cases and body mass index (BMI)-matched women without PCOS, identifying the possible influence factors.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: (1) subjects with a body mass index (BMI) = 24 kg/m2; (2) subjects aged between 18 and 40 years; (3) subjects who had not received any prescription or non-prescription drugs that affect insulin sensitivity or ovarian function, including hormonal contraceptives and metformin, within three months before the trial; (4) PCOS diagnosis fulfills the Rotterdam 2003 criteria phenotype B with hyperandrogenism (HA) and oligo-/anovulation [29]; (5) subjects who had not received medication that impacts lipid metabolism (fibrates, statins, antioxidants and diuretic) in the recent 3 months; (6) subjects who did not intend to become pregnant and use barrier contraception; (7) subjects who did not change their lifestyle, including physical activity and eating habits, during the study period. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• MRI
MRI-mDIXON-Quant examinations, anthropometric measures, body composition, hormonal and biochemical assays were performed in all participants, and the liver fat fraction (LFF) and muscle fat fraction (MFF) represented the fat content in the liver and skeletal muscle, respectively.

Locations
Country Name City State
China Shengjing Hospital of China Medical University Shenyang Liaoning

Sponsors (1)
Lead Sponsor Collaborator
Bing He

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary liver fat fraction liver fat fraction (LFF) represented the fat content in liver. 1 year
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