The Changes of Body Fat Distribution in Obese Patients With Polycystic Ovary Syndrome After Laparoscopic Sleeve Gastrectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- VAT mass
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
VAT mass
Time Frame: 12 months
visceral adipose tissue (VAT) mass
Secondary Outcomes
- SHBG(Baseline and 12 months)
- BMI(12 months)
- PBG(Baseline and 12 months)
- DHEAS(Baseline and 12 months)
- FBG(12 months)
- FINS(Baseline and 12 months)
- PINS(Baseline and 12 months)
- HDL-c(Baseline and 12 months)
- Ferriman-Gallwey score(Baseline and 12 months)
- TT(Baseline and 12 months)
- FT(Baseline and 12 months)
- AST(Baseline and 12 months)
- UA(Baseline and 12 months)
- LDL-c(Baseline and 12 months)
- TC(Baseline and 12 months)
- ALT(Baseline and 12 months)
- CR(Baseline and 12 months)
- TG(Baseline and 12 months)
- WHR(Baseline and 12 months)
- Menstrual Cycles(Baseline and 12 months)
- HOMA-IR(Baseline and 12 months)
- HC(Baseline and 12 months)
- LH(Baseline and 12 months)
- WC(Baseline and 12 months)
- FSH(Baseline and 12 months)
Investigators
Zhang Manna
Director, Principal Investigator, Clinical Professor
Shanghai 10th People's Hospital