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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Laparoscopic sleeve gastrectomy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

300 subjects with obesity or overweight

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LSG in obese; Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications	Procedure: Laparoscopic sleeve gastrectomy; bariatric surgery
Control group; healthy individuals with normal BMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic steatosis	hepatic steatosis assessed by FibroScan(CAP value and E value)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual cycles	the total number of menstrual periods in the last year	3 years
BMI	BMI=weight(kg)/height(m)^2	3 years
Waist/hip Ratio	WHR=Waist Circumference in centimeter/Hip Circumference in centimeter	3 years
TT	total testosterone in nmol/L	3 years
FBG	fasting blood-glucose in mmol/L	3 years
PBG	postprandial blood-glucose in mmol/L	3 years
FINS	fasting serum insulin in mU/L	3 years
PINS	postprandial insulin in mU/L	3 years
ALT	alanine aminotransferase in U/L	3 years
AST	aspartate aminotransferase in U/L	3 years
UA	Uric acid in umol/L	3 years
HOMA-IR	Homeostatic model assessment insulin resistance index=FBG*FINS/22.5	3 years
SHBG	sex hormone-binding globulin in nmol/L	3 years
FT	free testosterone (nmol/L)	3 years
DHEAS	Dehydroepiandrosterone Sulfate (ug/dl)	3 years
Fertility	sexual function, fertility	3 years
HbA1c (%)，	Glycated hemoglobin	3 years
LDL-C	low-density lipoprotein cholesterol in mmol/L、	3 years
HDL-C	Hight-density lipoprotein cholesterol in mmol/L、	3 years

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• Ma B, Yang P, Gao J, Du L, Sheng C, Usman T, Wang X, Qu S. Relationship of Vitamin A and Thyroid Function in Individuals With Obesity and After Laparoscopic Sleeve Gastrectomy. Front Nutr. 2022 Mar 15;9:824193. doi: 10.3389/fnut.2022.824193. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 10, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Polycystic Ovary Syndrome; Hyperuricemia; Hyperinsulinemia; Nonalcoholic Fatty Liver; Acanthosis nigricans; Laparoscopic sleeve Gastrectomy; Sleep apnea Syndrome
• Other Study ID Numbers: LSG in Obese Patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No