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NCT Number: NCT04548232

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

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.

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Key information

Conditions

Obesity Acanthosis Nigricans Adnexal Diseases Apnea Body Weight Cysts Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Dyssomnias Endocrine System Diseases Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hyperpigmentation Hyperuricemia Liver Diseases Melanosis Metabolic Diseases Neoplasms Nervous System Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Polycystic Ovary Syndrome Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

bariatric surgery

Primary outcomes

  1. Hepatic steatosis

    Time frame: 3 years

    hepatic steatosis assessed by FibroScan(CAP value and E value)

Secondary outcomes

  1. BMI

    Time frame: 3 years

    BMI=weight(kg)/height(m)^2

  2. Menstrual cycles

    Time frame: 3 years

    the total number of menstrual periods in the last year

  3. Waist/hip Ratio

    Time frame: 3 years

    WHR=Waist Circumference in centimeter/Hip Circumference in centimeter

  4. TT

    Time frame: 3 years

    total testosterone in nmol/L

  5. FBG

    Time frame: 3 years

    fasting blood-glucose in mmol/L

  6. PBG

    Time frame: 3 years

    postprandial blood-glucose in mmol/L

  7. FINS

    Time frame: 3 years

    fasting serum insulin in mU/L

  8. PINS

    Time frame: 3 years

    postprandial insulin in mU/L

  9. ALT

    Time frame: 3 years

    alanine aminotransferase in U/L

  10. AST

    Time frame: 3 years

    aspartate aminotransferase in U/L

  11. UA

    Time frame: 3 years

    Uric acid in umol/L

  12. HOMA-IR

    Time frame: 3 years

    Homeostatic model assessment insulin resistance index=FBG*FINS/22.5

  13. HbA1c (%)，

    Time frame: 3 years

    Glycated hemoglobin

  14. SHBG

    Time frame: 3 years

    sex hormone-binding globulin in nmol/L

  15. FT

    Time frame: 3 years

    free testosterone (nmol/L)

  16. DHEAS

    Time frame: 3 years

    Dehydroepiandrosterone Sulfate (ug/dl)

  17. LDL-C

    Time frame: 3 years

    low-density lipoprotein cholesterol in mmol/L、

  18. HDL-C

    Time frame: 3 years

    Hight-density lipoprotein cholesterol in mmol/L、

  19. Fertility

    Time frame: 3 years

    sexual function, fertility

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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