- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05592080
Exploring Liver and Muscle Fat Content Using MRI
Exploring Liver and Muscle Fat Content in Overweight and Obese Polycystic Ovary Syndrome Using Magnetic Resonance Imaging Technique
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110004
- Shengjing Hospital Of China Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
pcos
|
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.
|
non-pcos
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
liver fat fraction
Time Frame: 1 year
|
liver fat fraction (LFF) represented the fat content in liver.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022PS1008K
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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