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CompletedNCT04690634Updated Sep 13, 2022

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

An interventional study of laparoscopic sleeve gastrectomy (LSG) in Polycystic Ovary Syndrome, sponsored by Shanghai 10th People's Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled May 2020, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
153
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

Read the detailed description

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.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Laparoscopic Sleeve Gastrectomy
  • Body fat distribution
  • Dual-energy X-ray absorptiometry
  • Visceral adipose tissue
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 153 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Gender is male;
  2. Younger than 18 years old or older than 45 years old ;
  3. secondary obesity due to endocrine disorders;
  4. history of malignant tumors; 5）sever hepatic and renal disease;
  1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
153 participants (actual)

Study arms

  • Experimental
    PCOS group

    obese female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)

    Procedure: laparoscopic sleeve gastrectomy (LSG)

  • Active comparator
    control group

    obese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)

    Procedure: laparoscopic sleeve gastrectomy (LSG)

Interventions

  • Procedurelaparoscopic sleeve gastrectomy (LSG)

    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

06

What researchers measure

Primary outcomes

  1. VAT mass

    visceral adipose tissue (VAT) mass

    Time frame: 12 months

Secondary outcomes

  1. BMI

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

    Time frame: 12 months

  2. FBG

    fasting blood-glucose in mmol/L

    Time frame: 12 months

  3. PBG

    postprandial blood-glucose in mmol/L

    Time frame: Baseline and 12 months

  4. FINS

    fasting serum insulin in mU/L

    Time frame: Baseline and 12 months

  5. PINS

    postprandial insulin in mU/L

    Time frame: Baseline and 12 months

  6. ALT

    alanine aminotransferase in U/L

    Time frame: Baseline and 12 months

  7. AST

    aspartate aminotransferase in U/L）

    Time frame: Baseline and 12 months

  8. UA

    Uric acid in umol/L

    Time frame: Baseline and 12 months

  9. CR

    Creatinine in umol/L

    Time frame: Baseline and 12 months

  10. LDL-c

    low-density lipoprotein cholesterol in mmol/L

    Time frame: Baseline and 12 months

  11. HDL-c

    high-density lipoprotein cholesterol in mmol/L

    Time frame: Baseline and 12 months

  12. TC

    Total Cholesterol in mmol/L

    Time frame: Baseline and 12 months

  13. TG

    Triglyceride in mmol/L

    Time frame: Baseline and 12 months

  14. WHR

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

    Time frame: Baseline and 12 months

  15. HC

    Hip circumference

    Time frame: Baseline and 12 months

  16. Ferriman-Gallwey score

    Ferriman-Gallwey score

    Time frame: Baseline and 12 months

  17. Menstrual Cycles

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

    Time frame: Baseline and 12 months

  18. HOMA-IR

    homeostatic model assessment insulin resistance index

    Time frame: Baseline and 12 months

  19. TT

    total testosterone in nmol/L

    Time frame: Baseline and 12 months

  20. FT

    free testosterone (nmol/L)

    Time frame: Baseline and 12 months

  21. DHEAS

    Dehydroepiandrosterone Sulfate (ug/dl)

    Time frame: Baseline and 12 months

  22. SHBG

    sex hormone-binding globulin in nmol/L

    Time frame: Baseline and 12 months

  23. FSH

    follicle-stimulating hormone in IU/L

    Time frame: Baseline and 12 months

  24. LH

    luteinizing hormone in IU/L

    Time frame: Baseline and 12 months

  25. WC

    waist circumference,

    Time frame: Baseline and 12 months

07

Study locations

1 site
  • Department of Endocrinology, Shanghai Tenth People's Hospital
    Shanghai, Shanghai 200070, China
08

References and documents

Publications

  • Cai M, Gao J, Du L, Cheng X, Zhou D, Zhu J, Qu S, Zhang M. The Changes in Body Composition in Obese Patients with Polycystic Ovary Syndrome after Laparoscopic Sleeve Gastrectomy:a 12-Month Follow-up. Obes Surg. 2021 Sep;31(9):4055-4063. doi: 10.1007/s11695-021-05496-6. PubMed 34152560 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04690634
Lead sponsor
Shanghai 10th People's Hospital
Responsible party
Zhang Manna (Director, Principal Investigator, Clinical Professor, Shanghai 10th People's Hospital) — Principal investigator
First posted
Dec 31, 2020
Start date
May 1, 2020
Primary completion
May 1, 2021
Completion
May 1, 2021
Last update
Sep 13, 2022

Study contacts

Shen Qu, Dr
study chair · Shang hai Tenth People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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