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ObesityNCT04548232

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

An observational study of Obesity, run by Shanghai 10th People's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Laparoscopic sleeve gastrectomy
Type of treatment
Surgery or procedure
How many people
300 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 1 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 300 subjects with obesity or overweight

Who may be able to join

  • 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. -

Who cannot join

  • 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.

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
Laparoscopic sleeve gastrectomy
Keywords
Laparoscopic sleeve Gastrectomy, Nonalcoholic Fatty Liver, Type 2 Diabetes, Polycystic Ovary Syndrome, Acanthosis nigricans, Hyperuricemia, Hyperinsulinemia, Sleep apnea Syndrome
Medical subject headings
Obesity, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Polycystic Ovary Syndrome, Acanthosis Nigricans, Hyperuricemia, Hyperinsulinism, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve gastrectomyProcedure or surgery

    bariatric surgery

Study groups in NCT04548232
Study groupRoleWhat they receive
LSG in obesePatients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications
Receives: Procedure: Laparoscopic sleeve gastrectomy
Control grouphealthy individuals with normal BMI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatic steatosis

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

    Measured: 3 years

Secondary outcomes (19)

  1. BMI

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

    Measured: 3 years

  2. Menstrual cycles

    the total number of menstrual periods in the last year

    Measured: 3 years

  3. Waist/hip Ratio

    WHR=Waist Circumference in centimeter/Hip Circumference in centimeter

    Measured: 3 years

  4. TT

    total testosterone in nmol/L

    Measured: 3 years

  5. FBG

    fasting blood-glucose in mmol/L

    Measured: 3 years

  6. PBG

    postprandial blood-glucose in mmol/L

    Measured: 3 years

  7. FINS

    fasting serum insulin in mU/L

    Measured: 3 years

  8. PINS

    postprandial insulin in mU/L

    Measured: 3 years

  9. ALT

    alanine aminotransferase in U/L

    Measured: 3 years

  10. AST

    aspartate aminotransferase in U/L

    Measured: 3 years

  11. UA

    Uric acid in umol/L

    Measured: 3 years

  12. HOMA-IR

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

    Measured: 3 years

  13. HbA1c (%)，

    Glycated hemoglobin

    Measured: 3 years

  14. SHBG

    sex hormone-binding globulin in nmol/L

    Measured: 3 years

  15. FT

    free testosterone (nmol/L)

    Measured: 3 years

  16. DHEAS

    Dehydroepiandrosterone Sulfate (ug/dl)

    Measured: 3 years

  17. LDL-C

    low-density lipoprotein cholesterol in mmol/L、

    Measured: 3 years

  18. HDL-C

    Hight-density lipoprotein cholesterol in mmol/L、

    Measured: 3 years

  19. Fertility

    sexual function, fertility

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start1 Jan 2017
  3. Primary completion1 Dec 2021
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04548232
Sponsor's protocol ID
LSG in Obese Patients
Status last verified
Sep 2022
First submitted
7 Sep 2020
Last updated
14 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tong C, Mutailipu K, Chen R, Zhang Y, Lu L, Zha X, Ren T, Qu S, Su B, Bu L. Sex-Specific Mediators of Serum Uric Acid Reduction Following Laparoscopic Sleeve Gastrectomy: A Retrospective Longitudinal Study. Obes Surg. 2026 Nov 3. doi: 10.1007/s11695-026-08985-8. Online ahead of print.

    PubMed 42975827

  • Guo J, Tian P, Yu J, Lu G, Mutailipu K, Wen X, Wang X, You H, Zhu C, Lu L, Wang Y, Qu S, Chen H, Zhuang Y, Bu L. Development and External Validation of a Prediction Model for Hypoxemia After Laparoscopic Sleeve Gastrectomy in Patients with Obesity: a Multicenter Retrospective Study. Obes Surg. 2026 Jun;36(6):2767-2780. doi: 10.1007/s11695-025-07961-y. Epub 2026 Apr 24.

    PubMed 42029999

  • Wang X, Fang Y, Huang X, Du L, Ren H, Sheng C, Yang P, Huang Y, Qu S. Relationship of serum iron and thyroid hormone in obesity and after laparoscopic sleeve gastrectomy. BMC Endocr Disord. 2024 Nov 7;24(1):240. doi: 10.1186/s12902-024-01753-8.

    PubMed 39511506

  • 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.

    PubMed 35399676

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Shanghai 10th People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hepatic steatosis (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04548232, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.

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