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Completed

NCT Number: NCT05536583

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

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.,

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

Laparoscopic sleeve Gastrectomy

Primary outcomes

  1. Menstrual cycles

    Time frame: 3 years

    the total number of menstrual periods in the last year

Secondary outcomes

  1. ZAG

    Time frame: 3 years

    zinc-alpha2-glycoprotein

  2. FGF-19

    Time frame: 3 years

    fibroblast growth factor 19

  3. FGL-1

    Time frame: 3 years

    fibrinogen-like protein 1

  4. BMI

    Time frame: 3 years

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

  5. Waist/hip Ratio

    Time frame: 3 years

    WHR=Waist Circumference in centimeter/Hip Circumference in centimeter

  6. TT

    Time frame: 3 years

    total testosterone in nmol/L

  7. FBG

    Time frame: 3 years

    fasting blood-glucose in mmol/L

  8. PBG

    Time frame: 3 years

    postprandial blood-glucose in mmol/L

  9. FINS

    Time frame: 3 years

    fasting serum insulin in mU/L

  10. PINS

    Time frame: 3 years

    postprandial insulin in mU/L

  11. ALT

    Time frame: 3 years

    alanine aminotransferase in U/L

  12. AST

    Time frame: 3 years

    aspartate aminotransferase in U/L

  13. UA

    Time frame: 3 years

    Uric acid in umol/L

  14. HOMA-IR

    Time frame: 3 years

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

  15. HbA1c (%)

    Time frame: 3 years

    Glycated hemoglobin

  16. SHBG

    Time frame: 3 years

    sex hormone-binding globulin in nmol/L

  17. FT

    Time frame: 3 years

    free testosterone (nmol/L)

  18. DHEAS

    Time frame: 3 years

    Dehydroepiandrosterone Sulfate (ug/dl)

  19. LDL-C

    Time frame: 3 years

    low-density lipoprotein cholesterol in mmol/L

  20. HDL-C

    Time frame: 3 years

    Hight-density lipoprotein cholesterol in mmol/L

  21. Fertility

    Time frame: 3 years

    sexual function, fertility

  22. LH

    Time frame: 3 years

    luteinizing hormone in IU/L

  23. FSH

    Time frame: 3 years

    follicle-stimulating hormone in IU/l

  24. E2

    Time frame: 3 years

    Estradiol in pmol/L

  25. PRL

    Time frame: 3 years

    Prolactin in uIU/ml

  26. CR

    Time frame: 3 years

    Creatinine in umol/L

  27. AD

    Time frame: 3 years

    Androstenedione in ng/ml

  28. TC

    Time frame: 3 years

    Total Cholesterol (mmol/L)

  29. TG

    Time frame: 3 years

    Triglyceride (mmol/L)

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Sep 13, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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