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ObesityCOMESNCT06275061

Chinese Obesity and MEtabolic Surgery Database (COMES Database)

An observational study of Obesity and Metabolic Surgery, run by Jinan University Guangzhou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Obesity, Metabolic Surgery, Bariatric Surgery
What is being tested?
Metabolic and Bariatric Surgery
Type of treatment
Surgery or procedure
How many people
1,000,000 participants
Where
1 siteChina
Study dates
1 May 2020to 31 Dec 2040
How long will I take part?
30 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

Who may be able to join

  • Patients diagnosed as obesity undergoing metabolic and bariatric surgery.

Who cannot join

  • Patients treated by non-surgical modalities.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wah Yang, MD contact

+8615920373823

yangwah@qq.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

    Wah Yang, MD, +8615920373823, yangwah@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Metabolic and Bariatric Surgery
Keywords
Obesity, Metabolic Surgery, Bariatric Surgery, Weight Loss
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metabolic and Bariatric SurgeryProcedure or surgery

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

Study groups in NCT06275061
Study groupRoleWhat they receive
Metabolic and Bariatric SurgeryMetabolic and bariatric surgery is weight loss surgery that results in weight loss and resolution of metabolic disorders.
Receives: Procedure: Metabolic and Bariatric Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)]

    Measured: 1 year

Secondary outcomes (19)

  1. 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)]

    Measured: 3 years

  2. 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)]

    Measured: 5 years

  3. 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)]

    Measured: 10 years

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

    Change of HbA1c levels

    Measured: 1 year

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

    Change of HbA1c levels

    Measured: 3 years

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

    Change of HbA1c levels

    Measured: 5 years

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

    Change of HbA1c levels

    Measured: 10 years

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

    Change of blood glucose levels

    Measured: 1 year

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

    Change of blood glucose levels

    Measured: 3 years

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

    Change of blood glucose levels

    Measured: 5 years

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

    Change of blood glucose levels

    Measured: 10 years

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

    Change of C-peptide levels

    Measured: 1 year

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

    Change of C-peptide levels

    Measured: 3 years

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

    Change of C-peptide levels

    Measured: 5 years

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

    Change of C-peptide levels

    Measured: 10 years

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

    Change of insulin levels

    Measured: 1 year

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

    Change of insulin levels

    Measured: 3 years

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

    Change of insulin levels

    Measured: 5 years

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

    Change of insulin levels

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start1 May 2020
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000,000 participants (estimated)
Target duration
30 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275061
Sponsor's protocol ID
KY-2020-021
Acronym
COMES
Status last verified
Feb 2024
First submitted
15 Feb 2024
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Metabolic Surgery, run by Jinan University Guangzhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wah Yang, MD (+8615920373823, yangwah@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excess weight loss effect of metabolic and bariatric surgery after 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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