Polycystic Ovary SyndromeNCT06325956
PCOS Immune Function Predicts Metformin Efficacy
A study testing Metformin in people with Polycystic Ovary Syndrome and Metformin, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Metformin, Immune Function
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2024to 1 Jul 2026
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-45 years
- Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
Who cannot join
- Pregnant women;
- Hyperthyroidism or hypothyroidism
- Severe liver and kidney function injury
- Cancer patients;
- Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
- Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
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- Patients with mental illness or intellectual disability;
- Have taken drugs for PCOS treatment in the last three months;
- Have a long history of taking hormone therapy;
- Currently or recently participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, 200072
Manna Zhang, Doctor, 86-21-66301004, mannazhang@126.com
About this study
Official title: Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome
In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.
Read the detailed description
In this study, peripheral blood samples of PCOS patients were collected before and after intervention. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescently labeled antibodies in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
- Conditions
- Polycystic Ovary Syndrome, Metformin, Immune Function
- Being tested
- Metformin
- 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.
MetforminDrug
Also called Metformin therapy
Take metformin for six months.
| Study group | Role | What they receive |
|---|---|---|
| Metformin therapy | Experimental | Metformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
Measured: Samples to be collected once per participant within 7 days of enrollment.
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Secondary outcomes (14)
Homeostasis model assessment of insulin resistance
insulin resistance index
Measured: Within 7 days of enrollment.
body mass index
body mass index (kg/m2)
Measured: Within 7 days of enrollment.
menstrual frequency
number of menstruation in a year
Measured: Within 7 days of enrollment.
fasting glucose
fasting glucose (mmol/L)
Measured: Within 7 days of enrollment.
fasting insulin
fasting insulin (mmol/L)
Measured: Within 7 days of enrollment.
Total cholesterol
Total cholesterol (mmol/L)
Measured: Within 7 days of enrollment.
Triglycerides
Triglycerides (mmol/L)
Measured: Within 7 days of enrollment.
HDL-c
HDL-c (mmol/L)
Measured: Within 7 days of enrollment.
LDL-c
LDL-c (mmol/L)
Measured: Within 7 days of enrollment.
total testosterone
total testosterone (nmol/L)
Measured: Within 7 days of enrollment.
free testosterone
free testosterone (nmol/L)
Measured: Within 7 days of enrollment.
Sex hormone-binding globulin
Sex hormone-binding globulin (nmol/L)
Measured: Within 7 days of enrollment.
Androstenedione
Androstenedione (ng/ml)
Measured: Within 7 days of enrollment.
Dehydroepiandrosterone
Dehydroepiandrosterone (ug/dl)
Measured: Within 7 days of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start16 Mar 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Manna Zhang, doctor, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325956
- Sponsor's protocol ID
- Immune status and metformin
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06325956
- Acronym / sponsor ID
- Immune status and metformin
- Conditions
- Polycystic Ovary Syndrome, Metformin, Immune Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 22 Mar 2024 (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.
In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.
Detailed description
In this study, peripheral blood samples of PCOS patients were collected before and after intervention. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescently labeled antibodies in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin therapy | Experimental | Drug: MetforminMetformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 18-45 years
- Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
Key exclusion criteria (10 listed)
- Pregnant women;
- Hyperthyroidism or hypothyroidism
- Severe liver and kidney function injury
- Cancer patients;
- Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
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 |
|---|---|---|
| MetforminAlso: Metformin therapyTake metformin for six months. | Drug | Metformin therapy |
Primary outcome
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
14 secondary outcomes
Homeostasis model assessment of insulin resistance
Time frame: Within 7 days of enrollment.
body mass index
Time frame: Within 7 days of enrollment.
menstrual frequency
Time frame: Within 7 days of enrollment.
fasting glucose
Time frame: Within 7 days of enrollment.
fasting insulin
Time frame: Within 7 days of enrollment.
Total cholesterol
Time frame: Within 7 days of enrollment.
Triglycerides
Time frame: Within 7 days of enrollment.
HDL-c
Time frame: Within 7 days of enrollment.
LDL-c
Time frame: Within 7 days of enrollment.
total testosterone
Time frame: Within 7 days of enrollment.
free testosterone
Time frame: Within 7 days of enrollment.
Sex hormone-binding globulin
Time frame: Within 7 days of enrollment.
Androstenedione
Time frame: Within 7 days of enrollment.
Dehydroepiandrosterone
Time frame: Within 7 days of enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Manna Zhang, doctor principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Polycystic Ovary Syndrome and Metformin, run by Shanghai 10th People's Hospital 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manna Zhang, doctor (+8613774448495, mannazhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. (time frame: Samples to be collected once per participant within 7 days of enrollment.). The study lists 2 primary outcomes in all. 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 22 Mar 2024.