NCT06275061

Brief Summary

The purpose of the Chinese Obesity and MEtabolic Surgery Database (COMES Database) is to collect data and examine the long-term effects of metabolic and bariatric surgery on obesity and metabolic disorders in the Chinese population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
179mo left

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress29%
May 2020Dec 2040

Study Start

First participant enrolled

May 1, 2020

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

10.7 years

First QC Date

February 15, 2024

Last Update Submit

February 21, 2024

Conditions

Keywords

ObesityMetabolic SurgeryBariatric SurgeryWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Excess weight loss effect of metabolic and bariatric surgery after 1 year

    Percent excess weight loss (%EWL) = \[(initial weight)-(post-op weight)\]/\[(initial weight)-(ideal weight)\]

    1 year

Secondary Outcomes (19)

  • Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups

    3 years

  • Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups

    5 years

  • Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups

    10 years

  • Glycemic control effect of metabolic and bariatric surgery after 1 year

    1 year

  • Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups

    3 years

  • +14 more secondary outcomes

Other Outcomes (1)

  • Adverse events rate of metabolic and bariatric surgery

    30 days after surgery

Study Arms (1)

Metabolic and Bariatric Surgery

Metabolic and bariatric surgery is weight loss surgery that results in weight loss and resolution of metabolic disorders.

Procedure: Metabolic and Bariatric Surgery

Interventions

Metabolic and bariatric surgery is weight loss surgery that results in weight loss and resolution of metabolic disorders.

Metabolic and Bariatric Surgery

Eligibility Criteria

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

Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

You may qualify if:

  • Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

You may not qualify if:

  • Patients treated by non-surgical modalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Metabolic Networks and PathwaysBariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

MetabolismBariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Cunchuan Wang, MD, PhD

    First Affiliated Hospital of Jinan University

    STUDY CHAIR
  • Wah Yang, MD

    First Affiliated Hospital of Jinan University

    STUDY DIRECTOR

Central Study Contacts

Wah Yang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 23, 2024

Study Start

May 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2040

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations