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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04548232
Enrollment
300
Registered
2020-09-14
Start date
2017-01-01
Completion date
2022-01-01
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Laparoscopic sleeve Gastrectomy, Nonalcoholic Fatty Liver, Type 2 Diabetes, Polycystic Ovary Syndrome, Acanthosis nigricans, Hyperuricemia, Hyperinsulinemia, Sleep apnea Syndrome

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.

Interventions

PROCEDURELaparoscopic sleeve gastrectomy

bariatric surgery

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Hepatic steatosis3 yearshepatic steatosis assessed by FibroScan(CAP value and E value)

Secondary

MeasureTime frameDescription
Menstrual cycles3 yearsthe total number of menstrual periods in the last year
Waist/hip Ratio3 yearsWHR=Waist Circumference in centimeter/Hip Circumference in centimeter
TT3 yearstotal testosterone in nmol/L
FBG3 yearsfasting blood-glucose in mmol/L
PBG3 yearspostprandial blood-glucose in mmol/L
FINS3 yearsfasting serum insulin in mU/L
PINS3 yearspostprandial insulin in mU/L
ALT3 yearsalanine aminotransferase in U/L
AST3 yearsaspartate aminotransferase in U/L
BMI3 yearsBMI=weight(kg)/height(m)\^2
HOMA-IR3 yearsHomeostatic model assessment insulin resistance index=FBG\*FINS/22.5
HbA1c (%),3 yearsGlycated hemoglobin
SHBG3 yearssex hormone-binding globulin in nmol/L
FT3 yearsfree testosterone (nmol/L)
DHEAS3 yearsDehydroepiandrosterone Sulfate (ug/dl)
LDL-C3 yearslow-density lipoprotein cholesterol in mmol/L、
HDL-C3 yearsHight-density lipoprotein cholesterol in mmol/L、
Fertility3 yearssexual function, fertility
UA3 yearsUric acid in umol/L

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026