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

Tongji University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Procedure: laparoscopic sleeve gastrectomy (LSG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04690634

PCOS DEXA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

PCOS group

Experimental group

Description:

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

Treatment:

Procedure: laparoscopic sleeve gastrectomy (LSG)

control group

Active Comparator group

Description:

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

Treatment:

Procedure: laparoscopic sleeve gastrectomy (LSG)