Clinical trial NCT04690634: The Changes of Body Fat Distribution in Obese Patients With PCOS After LSG
Official title: The Changes of Body Fat Distribution in Obese Patients With Polycystic Ovary Syndrome After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Laparoscopic Sleeve Gastrectomy
Body fat distribution
Dual-energy X-ray absorptiometry
Visceral adipose tissue
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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;

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.

Primary outcomes:
measure: VAT mass
timeFrame: 12 months
Secondary outcomes:
measure: BMI
timeFrame: 12 months
measure: FBG
timeFrame: 12 months
measure: PBG
timeFrame: Baseline and 12 months
measure: FINS
timeFrame: Baseline and 12 months
measure: PINS
timeFrame: Baseline and 12 months
measure: ALT
timeFrame: Baseline and 12 months
measure: AST
timeFrame: Baseline and 12 months
measure: UA
timeFrame: Baseline and 12 months
measure: CR
timeFrame: Baseline and 12 months
measure: LDL-c
timeFrame: Baseline and 12 months
measure: HDL-c
timeFrame: Baseline and 12 months
measure: TC
timeFrame: Baseline and 12 months
measure: TG
timeFrame: Baseline and 12 months
measure: WHR
timeFrame: Baseline and 12 months
measure: HC
timeFrame: Baseline and 12 months
measure: Ferriman-Gallwey score
timeFrame: Baseline and 12 months
measure: Menstrual Cycles
timeFrame: Baseline and 12 months
measure: HOMA-IR
timeFrame: Baseline and 12 months
measure: TT
timeFrame: Baseline and 12 months
measure: FT
timeFrame: Baseline and 12 months
measure: DHEAS
timeFrame: Baseline and 12 months
measure: SHBG
timeFrame: Baseline and 12 months
measure: FSH
timeFrame: Baseline and 12 months
measure: LH
timeFrame: Baseline and 12 months
measure: WC
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shang hai Tenth People's Hospital
name: Shen Qu, Dr
role: STUDY_CHAIR
References:
citation: 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.