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NCT Number: NCT06275061

Chinese Obesity and MEtabolic Surgery Database (COMES 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.

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Key information

Conditions

Obesity Bariatric Surgery Body Weight Body Weight Changes Metabolic Surgery Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location status: Recruiting

Location contact

Wah Yang, MD

CONTACT

[email protected]

+8615920373823

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

Exclusion criteria

  • Patients treated by non-surgical modalities.

Treatment and study plan

Metabolic and Bariatric Surgery

Procedure

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

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

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

    Time frame: 3 years

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

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

    Time frame: 5 years

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

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

    Time frame: 10 years

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

  4. Glycemic control effect of metabolic and bariatric surgery after 1 year

    Time frame: 1 year

    Change of HbA1c levels

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

    Time frame: 3 years

    Change of HbA1c levels

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

    Time frame: 5 years

    Change of HbA1c levels

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

    Time frame: 10 years

    Change of HbA1c levels

  8. Glycemic control effect of metabolic and bariatric surgery after 1 year

    Time frame: 1 year

    Change of blood glucose levels

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

    Time frame: 3 years

    Change of blood glucose levels

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

    Time frame: 5 years

    Change of blood glucose levels

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

    Time frame: 10 years

    Change of blood glucose levels

  12. Glycemic control effect of metabolic and bariatric surgery after 1 year

    Time frame: 1 year

    Change of C-peptide levels

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

    Time frame: 3 years

    Change of C-peptide levels

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

    Time frame: 5 years

    Change of C-peptide levels

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

    Time frame: 10 years

    Change of C-peptide levels

  16. Glycemic control effect of metabolic and bariatric surgery after 1 year

    Time frame: 1 year

    Change of insulin levels

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

    Time frame: 3 years

    Change of insulin levels

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

    Time frame: 5 years

    Change of insulin levels

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

    Time frame: 10 years

    Change of insulin levels

Other outcomes

  1. Adverse events rate of metabolic and bariatric surgery

    Time frame: 30 days after surgery

    Surgical safety by 30 days follow-up according to guideline

Study contacts

Contact information is provided by the study sponsor or research team.

Wah Yang, MD

CONTACT

[email protected]

+8615920373823

Sponsors and collaborators

Lead sponsor

Jinan University Guangzhou

Other

Collaborators

  • Chinese Obesity and Metabolic Surgery Collaborative

Registry information

Official study title

Chinese Obesity and MEtabolic Surgery Database

Acronym: COMES

Important dates

Study start
2020
Primary completion
2030
Study completion
2040
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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