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NCT Number: NCT04690634

The Changes of Body Fat Distribution in Obese Patients With PCOS After LSG

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. Abdominal fat accumulation, overweightness and obesity are frequently present in patients with PCOS . Visceral adipose tissue (VAT) plays an important role in the pathogenesis of PCOS.Therefore，this study aim to investigate the changes of body fat distribution in obese women with PCOS after laparoscopic sleeve gastrectomy (LSG), and to explore the factors that may predict the changes in body fat distribution in PCOS patients after LSG.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

About this study

This study consecutively enrolled 153 patients with obesity aged 18-45 years (83 with PCOS and 70 control patients) who underwent LSG from May 2013 to September 2020 at the Department of Endocrinology, Shanghai Tenth People's Hospital, with a 12-month follow-up. Dual-energy X-ray absorptiometry (DEXA) was used to assess body fat distribution.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Fmale aged 18- 45;
  • Meet Rotterdam criteria(2003);
  • body mass index (BMI)≥30 kg/m2

Exclusion criteria

  • Gender is male;
  • Younger than 18 years old or older than 45 years old ;
  • secondary obesity due to endocrine disorders;
  • history of malignant tumors; 5）sever hepatic and renal disease;
  • concurrent participation in other clinical trials; 7) sever endocrine and hereditary diseases; 8) mental illnesses that rendered them unable to provide informed consent; 9) patients declining to undergo complete study testing.

Treatment and study plan

Laparoscopic Sleeve gastrectomy (LSG)

Procedure

Multiple studies have indicated that laparoscopic sleeve gastrectomy (LSG) was superior to nonsurgical approaches for the treatment of obese PCOS patients over both the short and long term

Primary outcomes

  1. VAT mass

    Time frame: 12 months

    visceral adipose tissue (VAT) mass

Secondary outcomes

  1. BMI

    Time frame: 12 months

    Body mass index (BMI) was calculated as follows: BMI = (body weight [kg])/(height [m2])

  2. FBG

    Time frame: 12 months

    fasting blood-glucose in mmol/L

  3. PBG

    Time frame: Baseline and 12 months

    postprandial blood-glucose in mmol/L

  4. FINS

    Time frame: Baseline and 12 months

    fasting serum insulin in mU/L

  5. PINS

    Time frame: Baseline and 12 months

    postprandial insulin in mU/L

  6. ALT

    Time frame: Baseline and 12 months

    alanine aminotransferase in U/L

  7. AST

    Time frame: Baseline and 12 months

    aspartate aminotransferase in U/L）

  8. UA

    Time frame: Baseline and 12 months

    Uric acid in umol/L

  9. CR

    Time frame: Baseline and 12 months

    Creatinine in umol/L

  10. LDL-c

    Time frame: Baseline and 12 months

    low-density lipoprotein cholesterol in mmol/L

  11. HDL-c

    Time frame: Baseline and 12 months

    high-density lipoprotein cholesterol in mmol/L

  12. TC

    Time frame: Baseline and 12 months

    Total Cholesterol in mmol/L

  13. TG

    Time frame: Baseline and 12 months

    Triglyceride in mmol/L

  14. WHR

    Time frame: Baseline and 12 months

    waist-to-hip ratio (WHR) were calculated as follows: WHR = (waist circumference [cm]/(hip circumference [cm]).

  15. HC

    Time frame: Baseline and 12 months

    Hip circumference

  16. Ferriman-Gallwey score

    Time frame: Baseline and 12 months

    Ferriman-Gallwey score

  17. Menstrual Cycles

    Time frame: Baseline and 12 months

    The number of menstrual cycles per year was defined as the number of menstruations during the last 12 months.

  18. HOMA-IR

    Time frame: Baseline and 12 months

    homeostatic model assessment insulin resistance index

  19. TT

    Time frame: Baseline and 12 months

    total testosterone in nmol/L

  20. FT

    Time frame: Baseline and 12 months

    free testosterone (nmol/L)

  21. DHEAS

    Time frame: Baseline and 12 months

    Dehydroepiandrosterone Sulfate (ug/dl)

  22. SHBG

    Time frame: Baseline and 12 months

    sex hormone-binding globulin in nmol/L

  23. FSH

    Time frame: Baseline and 12 months

    follicle-stimulating hormone in IU/L

  24. LH

    Time frame: Baseline and 12 months

    luteinizing hormone in IU/L

  25. WC

    Time frame: Baseline and 12 months

    waist circumference,

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

The Changes of Body Fat Distribution in Obese Patients With Polycystic Ovary Syndrome After Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
Registry last updated
Sep 13, 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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