Polycystic Ovary SyndromeNCT05592080
Exploring Liver and Muscle Fat Content Using MRI
An observational study of Polycystic Ovary Syndrome, run by Bing He at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: Exploring Liver and Muscle Fat Content in Overweight and Obese Polycystic Ovary Syndrome Using Magnetic Resonance Imaging Technique
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
- Being tested
- MRI
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| pcos | Not described Receives: Radiation: MRI | |
| non-pcos | Not described Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver fat fraction
liver fat fraction (LFF) represented the fat content in liver.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Oct 2021
- Primary completion1 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bing He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bing He, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592080
- Sponsor's protocol ID
- 2022PS1008K
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Liver and Muscle Fat Content in Overweight and Obese Polycystic Ovary Syndrome Using Magnetic Resonance Imaging Technique
- ClinicalTrials.gov ID
- NCT05592080
- Acronym / sponsor ID
- 2022PS1008K
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bing HeUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pcos | – | Radiation: MRI |
| non-pcos | – | Radiation: MRI |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI-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. | Radiation | non-pcos, pcos |
Primary outcome
liver fat fraction
Time frame: 1 year
liver fat fraction (LFF) represented the fat content in liver.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Bing He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver fat fraction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.