NCT04548232

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

4.9 years

First QC Date

September 7, 2020

Last Update Submit

September 10, 2022

Conditions

Obesity

Keywords

Laparoscopic sleeve GastrectomyNonalcoholic Fatty LiverType 2 DiabetesPolycystic Ovary SyndromeAcanthosis nigricansHyperuricemiaHyperinsulinemiaSleep apnea Syndrome

Outcome Measures

Primary Outcomes (1)

  • Hepatic steatosis

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

    3 years

Secondary Outcomes (19)

  • BMI

    3 years

  • Menstrual cycles

    3 years

  • Waist/hip Ratio

    3 years

  • TT

    3 years

  • FBG

    3 years

  • +14 more secondary outcomes

Study Arms (2)

LSG in obese

Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications

Procedure: Laparoscopic sleeve gastrectomy

Control group

healthy individuals with normal BMI

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

bariatric surgery

LSG in obese

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

300 subjects with obesity or overweight

You may qualify if:

  • \) 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. -

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 39511506DERIVED

  • 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.

    PMID: 35399676DERIVED

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver DiseaseDiabetes Mellitus, Type 2Polycystic Ovary SyndromeAcanthosis NigricansHyperuricemiaHyperinsulinismSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersMelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

January 1, 2017

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share