Chinese Obesity and MEtabolic Surgery Database (COMES Database)

Obesity Clinical Trial

— COMES  

Official title:

Chinese Obesity and MEtabolic Surgery Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275061
• Other study ID #: KY-2020-021
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 31, 2040

Study information

• Verified date: February 2024
• Source: Jinan University Guangzhou
• Contact: Wah Yang, MD
• Phone: +8615920373823
• Email: yangwah[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

Exclusion Criteria:

• Patients treated by non-surgical modalities.

Related Conditions & MeSH terms

• Bariatric Surgery
• Metabolic Surgery
• Obesity
• Weight Loss

Intervention

Procedure:
• Metabolic and Bariatric Surgery
Metabolic and bariatric surgery is weight loss surgery that results in weight loss and resolution of metabolic disorders.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Jinan University Guangzhou	Chinese Obesity and Metabolic Surgery Collaborative

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events rate of metabolic and bariatric surgery	Surgical safety by 30 days follow-up according to guideline	30 days after surgery
Primary	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	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
Secondary	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
Secondary	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
Secondary	Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of HbA1c levels	1 year
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of HbA1c levels	3 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of HbA1c levels	5 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of HbA1c levels	10 years
Secondary	Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of blood glucose levels	1 year
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of blood glucose levels	3 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of blood glucose levels	5 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of blood glucose levels	10 years
Secondary	Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of C-peptide levels	1 year
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of C-peptide levels	3 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of C-peptide levels	5 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of C-peptide levels	10 years
Secondary	Glycemic control effect of metabolic and bariatric surgery after 1 year	Change of insulin levels	1 year
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of insulin levels	3 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of insulin levels	5 years
Secondary	Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups	Change of insulin levels	10 years