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Polycystic Ovary SyndromeNCT04690634

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

A study testing laparoscopic sleeve gastrectomy (LSG) in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.

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

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 (LSG)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteChina
Study dates
1 May 2020to 1 May 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

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

Who cannot join

  • 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;
  • 6) 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Endocrinology, Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200070

Other trials in China

About this study

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

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.

Being tested
laparoscopic sleeve gastrectomy (LSG)
Keywords
Laparoscopic Sleeve Gastrectomy, Body fat distribution, Dual-energy X-ray absorptiometry, Visceral adipose tissue
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 gastrectomy (LSG)Procedure or surgery

    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

Study groups in NCT04690634
Study groupRoleWhat they receive
PCOS groupExperimentalobese female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)
Receives: Procedure: laparoscopic sleeve gastrectomy (LSG)
control groupActive comparatorobese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)
Receives: Procedure: laparoscopic sleeve gastrectomy (LSG)

What is being measured

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

  1. VAT mass

    visceral adipose tissue (VAT) mass

    Measured: 12 months

Secondary outcomes (25)

  1. BMI

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

    Measured: 12 months

  2. FBG

    fasting blood-glucose in mmol/L

    Measured: 12 months

  3. PBG

    postprandial blood-glucose in mmol/L

    Measured: Baseline and 12 months

  4. FINS

    fasting serum insulin in mU/L

    Measured: Baseline and 12 months

  5. PINS

    postprandial insulin in mU/L

    Measured: Baseline and 12 months

  6. ALT

    alanine aminotransferase in U/L

    Measured: Baseline and 12 months

  7. AST

    aspartate aminotransferase in U/L）

    Measured: Baseline and 12 months

  8. UA

    Uric acid in umol/L

    Measured: Baseline and 12 months

  9. CR

    Creatinine in umol/L

    Measured: Baseline and 12 months

  10. LDL-c

    low-density lipoprotein cholesterol in mmol/L

    Measured: Baseline and 12 months

  11. HDL-c

    high-density lipoprotein cholesterol in mmol/L

    Measured: Baseline and 12 months

  12. TC

    Total Cholesterol in mmol/L

    Measured: Baseline and 12 months

  13. TG

    Triglyceride in mmol/L

    Measured: Baseline and 12 months

  14. WHR

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

    Measured: Baseline and 12 months

  15. HC

    Hip circumference

    Measured: Baseline and 12 months

  16. Ferriman-Gallwey score

    Ferriman-Gallwey score

    Measured: 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.

    Measured: Baseline and 12 months

  18. HOMA-IR

    homeostatic model assessment insulin resistance index

    Measured: Baseline and 12 months

  19. TT

    total testosterone in nmol/L

    Measured: Baseline and 12 months

  20. FT

    free testosterone (nmol/L)

    Measured: Baseline and 12 months

  21. DHEAS

    Dehydroepiandrosterone Sulfate (ug/dl)

    Measured: Baseline and 12 months

  22. SHBG

    sex hormone-binding globulin in nmol/L

    Measured: Baseline and 12 months

  23. FSH

    follicle-stimulating hormone in IU/L

    Measured: Baseline and 12 months

  24. LH

    luteinizing hormone in IU/L

    Measured: Baseline and 12 months

  25. WC

    waist circumference,

    Measured: Baseline and 12 months

Timeline

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

  1. First posted31 Dec 2020
  2. Study start1 May 2020
  3. Primary completion1 May 2021
  4. Study completion1 May 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
Parallel Assignment
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690634
Sponsor's protocol ID
PCOS DEXA
Status last verified
Sep 2022
First submitted
20 Dec 2020
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing laparoscopic sleeve gastrectomy (LSG) 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 5 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 13 Sep 2022. 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.

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?

VAT mass (time frame: 12 months). 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 NCT04690634, which also lists 1 linked publication.

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 13 Sep 2022.

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