Chinese Obesity and MEtabolic Surgery Database (COMES Database) (COMES)

Chinese Obesity and MEtabolic Surgery Database

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Loss; Bariatric Surgery; Metabolic Surgery
• Intervention / Treatment: Procedure: Metabolic and Bariatric Surgery

Detailed Description

COMES Database is a prospective managed national database to collect data and examine the long-term effects of metabolic and bariatric surgery on obesity and metabolic disorders in the Chinese population.

• Study Type: Observational
• Enrollment (Estimated): 1000000

Contacts and Locations

• Study Contact: Name: Wah Yang, MD; Phone Number: +8615920373823; Email: yangwah@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Wah Yang, MD; Phone Number: +8615920373823; Email: yangwah@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

Description

Inclusion Criteria:

• Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

Exclusion Criteria:

• Patients treated by non-surgical modalities.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Metabolic and bariatric surgery is weight loss surgery that results in weight loss and resolution of metabolic disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups	Percent excess weight loss (%EWL) = [(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)]	3 years
Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups	Percent excess weight loss (%EWL) = [(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)]	5 years
Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups	Percent excess weight loss (%EWL) = [(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)]	10 years
Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of HbA1c levels	1 year
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of HbA1c levels	3 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of HbA1c levels	5 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of HbA1c levels	10 years
Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of blood glucose levels	1 year
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of blood glucose levels	3 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of blood glucose levels	5 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of blood glucose levels	10 years
Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of C-peptide levels	1 year
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of C-peptide levels	3 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of C-peptide levels	5 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of C-peptide levels	10 years
Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of insulin levels	1 year
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of insulin levels	3 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of insulin levels	5 years
Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of insulin levels	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events rate of metabolic and bariatric surgery	Surgical safety by 30 days follow-up according to guideline	30 days after surgery

Collaborators and Investigators

• Sponsor: Jinan University Guangzhou
• Collaborators: Chinese Obesity and Metabolic Surgery Collaborative
• Investigators: Study Chair: Cunchuan Wang, MD, PhD, First Affiliated Hospital of Jinan University; Study Director: Wah Yang, MD, First Affiliated Hospital of Jinan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Weight Loss; Bariatric Surgery; Metabolic Surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: KY-2020-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No