Clinical trial NCT04548232: Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients
Official title: Shanghai Tenth People's Hospital，School of Medicine, Tongji University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Laparoscopic sleeve Gastrectomy
Nonalcoholic Fatty Liver
Type 2 Diabetes
Polycystic Ovary Syndrome
Acanthosis nigricans
Hyperuricemia
Hyperinsulinemia
Sleep apnea Syndrome
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 subjects with obesity or overweight

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hepatic steatosis
timeFrame: 3 years
Secondary outcomes:
measure: BMI
timeFrame: 3 years
measure: Menstrual cycles
timeFrame: 3 years
measure: Waist/hip Ratio
timeFrame: 3 years
measure: TT
timeFrame: 3 years
measure: FBG
timeFrame: 3 years
measure: PBG
timeFrame: 3 years
measure: FINS
timeFrame: 3 years
measure: PINS
timeFrame: 3 years
measure: ALT
timeFrame: 3 years
measure: AST
timeFrame: 3 years
measure: UA
timeFrame: 3 years
measure: HOMA-IR
timeFrame: 3 years
measure: HbA1c (%)，
timeFrame: 3 years
measure: SHBG
timeFrame: 3 years
measure: FT
timeFrame: 3 years
measure: DHEAS
timeFrame: 3 years
measure: LDL-C
timeFrame: 3 years
measure: HDL-C
timeFrame: 3 years
measure: Fertility
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.