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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06275061
Other study ID # KY-2020-021
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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