NCT02653430

Brief Summary

This is a long-term follow-up and interventional study in individuals who have been diagnosed with moderate to severe obesity with or without diabetes. The purpose of this study is to determine the effects of sleeve gastrectomy on weight and blood sugar control and underlying mechanisms by metabolomics, metagenomics, functional magnetic resonance imaging (fMRI) ,adipose tissue expression chip and etc.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 26, 2016

Status Verified

January 1, 2016

Enrollment Period

6.8 years

First QC Date

December 30, 2015

Last Update Submit

April 25, 2016

Conditions

Morbid Obesity

Keywords

obesityBMIefficacybariatric surgerygut florafMRI

Outcome Measures

Primary Outcomes (1)

  • Excess Weight Loss

    up to 10 years

Secondary Outcomes (11)

  • Remission rate of type 2 diabetes mellitus or control of glycemia

    up to 10 years

  • Waist circumference

    up to 10 years

  • Hip circumference

    up to 10 years

  • Fat percent determined by Inbody 720

    up to 10 years

  • Assessment of insulin resistance

    up to 10 years

  • +6 more secondary outcomes

Study Arms (1)

Bariatric Surgery

EXPERIMENTAL

Sleeve Gastrectomy

Procedure: Sleeve gastrectomy

Interventions

Sleeve gastrectomyPROCEDURE

After complete exams such as EKG，UCG，spirometry and other basic exams,estimate the condition of patient whether he(she) can tolerate a surgical operation.Then we operate the"Sleeve gastrectomy laparoscopically" by a group of experienced surgeons.

Bariatric Surgery

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BMI≥35kg/m2 with or without obesity complications
  • BMI≥32kg/m2 with type 2 diabetes, high blood pressure, severe OSAHS, atherosclerotic plaque formation or other obesity complications
  • Type 2 diabetes duration of ≤ 15 years, half of the lower limit of normal islet reserve function or more, C peptide ≥2.

You may not qualify if:

  • had an operation for losing weight before
  • serious hepatic or renal dysfunction
  • mentally ill，serious tristimania，personality disturbance，disgnosia
  • drug abuse or alcool abuse
  • ulcer or tumor history or other high risks for surgery or serious gastrointestinal disease
  • can not be follow-up，refuse to change the life-style
  • type 1 diabetes mellitus
  • self-care disable or no familial care
  • obesity caused by drugs
  • secondary obesity, such as monogenic obesity, obesity-related genetic syndrome, cushing syndrome and etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (2)

  • Hong J, Bo T, Xi L, Xu X, He N, Zhan Y, Li W, Liang P, Chen Y, Shi J, Li D, Yan F, Gu W, Wang W, Liu R, Wang J, Wang Z, Ning G. Reversal of Functional Brain Activity Related to Gut Microbiome and Hormones After VSG Surgery in Patients With Obesity. J Clin Endocrinol Metab. 2021 Aug 18;106(9):e3619-e3633. doi: 10.1210/clinem/dgab297.

    PMID: 33950216DERIVED

  • Chen Y, Chen L, Ye L, Jin J, Sun Y, Zhang L, Zhao S, Zhang Y, Wang W, Gu W, Hong J. Association of Metabolic Syndrome With Prevalence of Obstructive Sleep Apnea and Remission After Sleeve Gastrectomy. Front Physiol. 2021 Mar 31;12:650260. doi: 10.3389/fphys.2021.650260. eCollection 2021.

    PMID: 33868016DERIVED

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guang Ning, MD,PhD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, MD,PhD

CONTACT

86-21-64370045guangning@medmail.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 30, 2015

First Posted

January 12, 2016

Study Start

February 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 26, 2016

Record last verified: 2016-01

Locations

CN(1)