Exploring Liver and Muscle Fat Content Using MRI

NCT05592080 | Completed

• 1 other identifier: 2022PS1008K
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• liver fat fraction

  liver fat fraction (LFF) represented the fat content in liver.

  1 year

Study Arms (2)

pcos

Radiation: MRI

non-pcos

Radiation: MRI

Interventions

MRI RADIATION

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; pcos

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

(1) subjects with other causes of irregular menstrual cycles or androgen excess including hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, Cushing's disease, androgen secreting tumor, or pregnancy; (2)subjects with abnormal liver function test results (ALT level 2.5 times higher than the upper limit of the normal range); (3) subjects with renal insufficiency (eGFR \< 60 ml/min/1.73 m2); (4) subjects with a history of chronic liver diseases such as alcoholic liver disease, viral hepatitis, autoimmune liver disease, drug-induced liver disease, genetic metabolic liver disease; (5) subjects experiencing alcoholism (weekly alcohol intake \> 100 g) subjects experiencing smoking within the past 3 months and engaging in high-intensity exercise; (6) subjects with a history of cancer; (7) subjects with active infection; subjects who were pregnant or breastfeeding.

You may qualify if:

• (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.

Sponsors & Collaborators

• Bing He: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: October 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

CN (1)