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Polycystic Ovary SyndromeNCT05536583

Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS

A study testing Laparoscopic sleeve Gastrectomy in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy. 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
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
1 May 2013to 31 Dec 2021
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

  • age ranged from 18~45 years old,
  • BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

Who cannot join

  • outside of the 18-45 age range;
  • secondary obesity caused by endocrine disorders;
  • history of more than one bariatric procedure;
  • severe hepatic, renal or heart dysfunction;
  • mental illnesses or intellectual disability.
  • pregnancy or lactation
  • contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,

About this study

Official title: Shanghai Tenth People's Hospital，School of Medicine, Tongji University

This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.

Read the detailed description

This study aims to evaluate the clinical efficacy and safety of laparoscopic sleeve gastrectomy in obese patients with Polycystic Ovary Syndrome（PCOS). About 100 obese patients with PCOS and 100 simple obese patients (without complications) were enrolled.

All PCOS patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis were measured baseline and postoperative.

Being tested
Laparoscopic sleeve Gastrectomy
Keywords
Polycystic ovary syndrome, Laparoscopic sleeve gastrectomy, Obesity, menstrual cycle
Medical subject headings
Polycystic Ovary Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve GastrectomyProcedure or surgery

    Laparoscopic sleeve Gastrectomy

Study groups in NCT05536583
Study groupRoleWhat they receive
PCOS groupExperimentalObese Patients with PCOS underwent LSG
Receives: Procedure: Laparoscopic sleeve Gastrectomy
Control groupActive comparatorSample obese patients without PCOS underwent LSG
Receives: Procedure: Laparoscopic sleeve Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Menstrual cycles

    the total number of menstrual periods in the last year

    Measured: 3 years

Secondary outcomes (29)

  1. ZAG

    zinc-alpha2-glycoprotein

    Measured: 3 years

  2. FGF-19

    fibroblast growth factor 19

    Measured: 3 years

  3. FGL-1

    fibrinogen-like protein 1

    Measured: 3 years

  4. BMI

    BMI=weight(kg)/height(m)^2

    Measured: 3 years

  5. Waist/hip Ratio

    WHR=Waist Circumference in centimeter/Hip Circumference in centimeter

    Measured: 3 years

  6. TT

    total testosterone in nmol/L

    Measured: 3 years

  7. FBG

    fasting blood-glucose in mmol/L

    Measured: 3 years

  8. PBG

    postprandial blood-glucose in mmol/L

    Measured: 3 years

  9. FINS

    fasting serum insulin in mU/L

    Measured: 3 years

  10. PINS

    postprandial insulin in mU/L

    Measured: 3 years

  11. ALT

    alanine aminotransferase in U/L

    Measured: 3 years

  12. AST

    aspartate aminotransferase in U/L

    Measured: 3 years

  13. UA

    Uric acid in umol/L

    Measured: 3 years

  14. HOMA-IR

    Homeostatic model assessment insulin resistance index=FBG*FINS/22.5

    Measured: 3 years

  15. HbA1c (%)

    Glycated hemoglobin

    Measured: 3 years

  16. SHBG

    sex hormone-binding globulin in nmol/L

    Measured: 3 years

  17. FT

    free testosterone (nmol/L)

    Measured: 3 years

  18. DHEAS

    Dehydroepiandrosterone Sulfate (ug/dl)

    Measured: 3 years

  19. LDL-C

    low-density lipoprotein cholesterol in mmol/L

    Measured: 3 years

  20. HDL-C

    Hight-density lipoprotein cholesterol in mmol/L

    Measured: 3 years

  21. Fertility

    sexual function, fertility

    Measured: 3 years

  22. LH

    luteinizing hormone in IU/L

    Measured: 3 years

  23. FSH

    follicle-stimulating hormone in IU/l

    Measured: 3 years

  24. E2

    Estradiol in pmol/L

    Measured: 3 years

  25. PRL

    Prolactin in uIU/ml

    Measured: 3 years

  26. CR

    Creatinine in umol/L

    Measured: 3 years

  27. AD

    Androstenedione in ng/ml

    Measured: 3 years

  28. TC

    Total Cholesterol (mmol/L)

    Measured: 3 years

  29. TG

    Triglyceride (mmol/L)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start1 May 2013
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2021

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536583
Sponsor's protocol ID
LSG in PCOS patients
Status last verified
Sep 2022
First submitted
6 Sep 2022
Last updated
3 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic sleeve Gastrectomy in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital.

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 7 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 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Menstrual cycles (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536583.

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 3 Oct 2022.

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