Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548232
• Other study ID #: LSG in Obese Patients
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2022

Study information

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

Clinical Trial Summary

This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.

Description:

This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled. All 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 assessed by FibroScan(CAP value and E value) were measured baseline and postoperative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

1) age ranged from 16~65 years old, 2) 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:

• 1) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
bariatric surgery

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	Hepatic steatosis	hepatic steatosis assessed by FibroScan(CAP value and E value)	3 years
Secondary	BMI	BMI=weight(kg)/height(m)^2	3 years
Secondary	Menstrual cycles	the total number of menstrual periods in the last year	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