Clinical trial NCT05536583: Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS
Official title: Shanghai Tenth People's Hospital，School of Medicine, Tongji University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
Laparoscopic sleeve gastrectomy
Obesity
menstrual cycle
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 200
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: Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.,

Primary outcomes:
measure: Menstrual cycles
timeFrame: 3 years
Secondary outcomes:
measure: ZAG
timeFrame: 3 years
measure: FGF-19
timeFrame: 3 years
measure: FGL-1
timeFrame: 3 years
measure: BMI
timeFrame: 3 years
measure: Waist/hip Ratio
timeFrame: 3 years
measure: TT
timeFrame: 3 years
measure: FBG
timeFrame: 3 years
measure: PBG
timeFrame: 3 years
measure: FINS
timeFrame: 3 years
measure: PINS
timeFrame: 3 years
measure: ALT
timeFrame: 3 years
measure: AST
timeFrame: 3 years
measure: UA
timeFrame: 3 years
measure: HOMA-IR
timeFrame: 3 years
measure: HbA1c (%)
timeFrame: 3 years
measure: SHBG
timeFrame: 3 years
measure: FT
timeFrame: 3 years
measure: DHEAS
timeFrame: 3 years
measure: LDL-C
timeFrame: 3 years
measure: HDL-C
timeFrame: 3 years
measure: Fertility
timeFrame: 3 years
measure: LH
timeFrame: 3 years
measure: FSH
timeFrame: 3 years
measure: E2
timeFrame: 3 years
measure: PRL
timeFrame: 3 years
measure: CR
timeFrame: 3 years
measure: AD
timeFrame: 3 years
measure: TC
timeFrame: 3 years
measure: TG
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: