Clinical Efficacy and Safety of Laparoscopic Sleeve Gastrectomy in Obese Patients With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Shanghai Tenth People's Hospital，School of Medicine, Tongji University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536583
• Other study ID #: LSG in PCOS patients
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: December 31, 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.,

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Procedure:
• Laparoscopic sleeve Gastrectomy
Laparoscopic sleeve Gastrectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual cycles	the total number of menstrual periods in the last year	3 years
Secondary	ZAG	zinc-alpha2-glycoprotein	3 years
Secondary	FGF-19	fibroblast growth factor 19	3 years
Secondary	FGL-1	fibrinogen-like protein 1	3 years
Secondary	BMI	BMI=weight(kg)/height(m)^2	3 years
Secondary	Waist/hip Ratio	WHR=Waist Circumference in centimeter/Hip Circumference in centimeter	3 years
Secondary	TT	total testosterone in nmol/L	3 years
Secondary	FBG	fasting blood-glucose in mmol/L	3 years
Secondary	PBG	postprandial blood-glucose in mmol/L	3 years
Secondary	FINS	fasting serum insulin in mU/L	3 years
Secondary	PINS	postprandial insulin in mU/L	3 years
Secondary	ALT	alanine aminotransferase in U/L	3 years
Secondary	AST	aspartate aminotransferase in U/L	3 years
Secondary	UA	Uric acid in umol/L	3 years
Secondary	HOMA-IR	Homeostatic model assessment insulin resistance index=FBG*FINS/22.5	3 years
Secondary	HbA1c (%)	Glycated hemoglobin	3 years
Secondary	SHBG	sex hormone-binding globulin in nmol/L	3 years
Secondary	FT	free testosterone (nmol/L)	3 years
Secondary	DHEAS	Dehydroepiandrosterone Sulfate (ug/dl)	3 years
Secondary	LDL-C	low-density lipoprotein cholesterol in mmol/L	3 years
Secondary	HDL-C	Hight-density lipoprotein cholesterol in mmol/L	3 years
Secondary	Fertility	sexual function, fertility	3 years
Secondary	LH	luteinizing hormone in IU/L	3 years
Secondary	FSH	follicle-stimulating hormone in IU/l	3 years
Secondary	E2	Estradiol in pmol/L	3 years
Secondary	PRL	Prolactin in uIU/ml	3 years
Secondary	CR	Creatinine in umol/L	3 years
Secondary	AD	Androstenedione in ng/ml	3 years
Secondary	TC	Total Cholesterol (mmol/L)	3 years
Secondary	TG	Triglyceride (mmol/L)	3 years