Polycystic Ovary SyndromePhase 4NCT04508634
Treating Obese PCOS Patients With LSG vs. Met
A Phase 4 study testing laparoscopic sleeve gastrectomy and Metformin Pill in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- laparoscopic sleeve gastrectomy and Metformin Pill
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Sep 2024
- Phase
- Phase 4
- 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
- female aged 18- 45;
- meet Rotterdam criteria;
- BMI ≥ 28 kg /m2.
Who cannot join
- Women who are pregnant or have a pregnancy plan within six months;
- Women who are reluctant to undergo metabolic surgery;
- Congenital adrenocortical hyperplasia;
- Hyperprolactinemia;
- Hyperthyroidism or hypothyroidism;
- Abnormal liver function (≥ 3 times of the upper limit of normal range); abnormal · Rrenal function (GFR<60ml/min/1.73m2);
- Adrenal or ovarian tumors secreting androgens;
- Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People' Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- laparoscopic sleeve gastrectomy, Metformin Pill
- 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.
laparoscopic sleeve gastrectomyProcedure or surgery
Also called Sleeve Operation
laparoscopic sleeve gastrectomy
Metformin PillDrug
Metformin 1000mg bid
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic sleeve gastrectomy | Experimental | laparoscopic sleeve gastrectomy Receives: Procedure: laparoscopic sleeve gastrectomy |
| Metformin Group | Active comparator | Metformin Group Receives: Drug: Metformin Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR
Insulin resistance index
Measured: 3 months
Screening of metabolites in plasma concentration in fasting condition
The investigators will perform metabolites to identify the changes that may give rise to the disease.
Measured: 3 months
Screening of transcriptome profile in plasma concentration in fasting condition
The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.
Measured: 3 months
Screening of Microbiome in faeces
The investigators will perform Microbiome to identify the changes that may give rise to the disease.
Measured: 3 months
Secondary outcomes (9)
menstrual cycles
menstrual frequency
Measured: 3 months
Gonadotropin level
LH(IU/L) , FSH (IU/L),
Measured: 3 months
testosterone
total testosterone (nmol/L), testosterone (nmol/L)
Measured: 3 months
SHBG level
SHBG (nmol/L).
Measured: 3 months
FINS
fasting insulin (IU/L)
Measured: 3 months
TC
Total cholesterol (mmol/L)
Measured: 3 months
TG
Triglycerides (mmol/L)
Measured: 3 months
HDL-c
high-density lipoprotein cholesterol (mmol/L)
Measured: 3 months
LDL-c
low-density lipoprotein cholesterol (mmol/L)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Nov 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Sep 2024 (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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- laparoscopic sleeve gastrectomy
- Masking
- None (open label)
- Enrolment
- 90 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
- Shen Qu, Dr, Study chair, Shang hai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508634
- Sponsor's protocol ID
- LSG vs. Met in PCOS
- Status last verified
- Apr 2023
- First submitted
- 7 Aug 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy of Laparoscopic Sleeve Gastrectomy and Metformin in the Treatment of Obese Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04508634
- Acronym / sponsor ID
- LSG vs. Met in PCOS
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Aug 2020 (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.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- laparoscopic sleeve gastrectomy
| Arm | Type | Receives |
|---|---|---|
| laparoscopic sleeve gastrectomy | Experimental | Procedure: laparoscopic sleeve gastrectomylaparoscopic sleeve gastrectomy |
| Metformin Group | Active comparator | Drug: Metformin PillMetformin Group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female aged 18- 45;
- meet Rotterdam criteria;
- BMI ≥ 28 kg /m2.
Key exclusion criteria (8 listed)
- Women who are pregnant or have a pregnancy plan within six months;
- Women who are reluctant to undergo metabolic surgery;
- Congenital adrenocortical hyperplasia;
- Hyperprolactinemia;
- Hyperthyroidism or hypothyroidism;
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 |
|---|---|---|
| laparoscopic sleeve gastrectomyAlso: Sleeve Operationlaparoscopic sleeve gastrectomy | Procedure or surgery | laparoscopic sleeve gastrectomy |
| Metformin PillMetformin 1000mg bid | Drug | Metformin Group |
Primary outcome
HOMA-IR
Time frame: 3 months
Insulin resistance index
Screening of metabolites in plasma concentration in fasting condition
Time frame: 3 months
The investigators will perform metabolites to identify the changes that may give rise to the disease.
Screening of transcriptome profile in plasma concentration in fasting condition
Time frame: 3 months
The investigators will perform transcriptome profile to identify the changes that may give rise to the disease.
Screening of Microbiome in faeces
Time frame: 3 months
The investigators will perform Microbiome to identify the changes that may give rise to the disease.
9 secondary outcomes
menstrual cycles
Time frame: 3 months
Gonadotropin level
Time frame: 3 months
testosterone
Time frame: 3 months
SHBG level
Time frame: 3 months
FINS
Time frame: 3 months
TC
Time frame: 3 months
TG
Time frame: 3 months
HDL-c
Time frame: 3 months
LDL-c
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
RecruitingObservational study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
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Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Not yet recruitingObservational study
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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.
Shen Qu, Dr study chair
Shang hai Tenth 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 Phase 4 study testing laparoscopic sleeve gastrectomy and Metformin Pill in people with Polycystic Ovary Syndrome, 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 3 inclusion and 8 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 12 Apr 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
HOMA-IR (time frame: 3 months). The study lists 4 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 12 Apr 2023.