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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690634
• Other study ID #: PCOS DEXA
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2022
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• laparoscopic sleeve gastrectomy (LSG)
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

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAT mass	visceral adipose tissue (VAT) mass	12 months
Secondary	BMI	Body mass index (BMI) was calculated as follows: BMI = (body weight [kg])/(height [m2])	12 months
Secondary	FBG	fasting blood-glucose in mmol/L	12 months
Secondary	PBG	postprandial blood-glucose in mmol/L	Baseline and 12 months
Secondary	FINS	fasting serum insulin in mU/L	Baseline and 12 months
Secondary	PINS	postprandial insulin in mU/L	Baseline and 12 months
Secondary	ALT	alanine aminotransferase in U/L	Baseline and 12 months
Secondary	AST	aspartate aminotransferase in U/L)	Baseline and 12 months
Secondary	UA	Uric acid in umol/L	Baseline and 12 months
Secondary	CR	Creatinine in umol/L	Baseline and 12 months
Secondary	LDL-c	low-density lipoprotein cholesterol in mmol/L	Baseline and 12 months
Secondary	HDL-c	high-density lipoprotein cholesterol in mmol/L	Baseline and 12 months
Secondary	TC	Total Cholesterol in mmol/L	Baseline and 12 months
Secondary	TG	Triglyceride in mmol/L	Baseline and 12 months
Secondary	WHR	waist-to-hip ratio (WHR) were calculated as follows: WHR = (waist circumference [cm]/(hip circumference [cm]).	Baseline and 12 months
Secondary	HC	Hip circumference	Baseline and 12 months
Secondary	Ferriman-Gallwey score	Ferriman-Gallwey score	Baseline and 12 months
Secondary	Menstrual Cycles	The number of menstrual cycles per year was defined as the number of menstruations during the last 12 months.	Baseline and 12 months
Secondary	HOMA-IR	homeostatic model assessment insulin resistance index	Baseline and 12 months
Secondary	TT	total testosterone in nmol/L	Baseline and 12 months
Secondary	FT	free testosterone (nmol/L)	Baseline and 12 months
Secondary	DHEAS	Dehydroepiandrosterone Sulfate (ug/dl)	Baseline and 12 months
Secondary	SHBG	sex hormone-binding globulin in nmol/L	Baseline and 12 months
Secondary	FSH	follicle-stimulating hormone in IU/L	Baseline and 12 months
Secondary	LH	luteinizing hormone in IU/L	Baseline and 12 months
Secondary	WC	waist circumference,	Baseline and 12 months

External Links

•   The Changes in Body Composition in Obese Patients with Polycystic Ovary Syndrome after Laparoscopic Sleeve Gastrectomy:a 12-Month Follow-up