ObesityODHMNCT07451938
A Cohort Study on Obese Patients' Multidisciplinary Integrated Health Management
An observational study of Obesity and Diabete Type 2, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
To explore influencing factors of diabetes remission and recovery of other complications after bariatric surgery. We design a multicenter study including respective cohort and prorespective cohort of obese patients treated with bariatric surgery or non-bariatric surgery，and collect clinical parameters and laboratory… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Obesity, Diabete Type 2, Bariatric Surgery
- What is being tested?
- Bariatric surgery and Non-surgical threapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Obese patients treated with bariatric surgery or non-bariatric surgery(diet, exercise and weight loss drugs)
Who may be able to join
- Age range from 12 to 75 years,
- BMI (Body Mass Index) ≥ 25.0 kg/m2,
Who cannot join
- Type 1 diabetes,
- Severe liver or kidney disease (eGFR < 30 ml/min), malignant tumors, endocrine disorders such as thyroid or Cushing's syndrome, acute coronary syndrome, uncontrolled heart failure, pregnancy or lactation, pancreatitis,
- Contraindications to other surgeries or medications.
Trial locations and contacts
1 site in 1 country.
About this study
To explore influencing factors of diabetes remission and recovery of other complications after bariatric surgery. We design a multicenter study including respective cohort and prorespective cohort of obese patients treated with bariatric surgery or non-bariatric surgery，and collect clinical parameters and laboratory indicators.
- Conditions
- Obesity, Diabete Type 2, Bariatric Surgery
- Being tested
- Bariatric surgery, Non-surgical threapy
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function
Non-surgical threapyOther
Diet management，exercise，metformin，GLP-1RA and other drugs which can lose weight.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Not described Receives: Procedure: Bariatric surgery; Other: Non-surgical threapy | |
| Non-surgical group | Not described Receives: Other: Non-surgical threapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weight loss
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Secondary outcomes (13)
Fasting blood glucose
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Average blood glucose from continuous glucose monitoring
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Postprandial 2-hour blood glucose
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
HbA1c
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Waist circumference and hip circumference
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Medication status
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Quality of life score
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
AHI
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
GERDQ Score
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Urinary microalbumin
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Serum creatinine
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
TC
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
TG
Measured: 1st, 3rd, 6th and 12th month after intervention, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jul 2017
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Meng, China-Japan Friendship Hospital
- Investigators
- Hua Meng, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451938
- Sponsor's protocol ID
- ODHM
- Acronym
- ODHM
- Status last verified
- Nov 2025
- First submitted
- 16 May 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Obese Patients' Multidisciplinary Integrated Health Management
- ClinicalTrials.gov ID
- NCT07451938
- Acronym / sponsor ID
- ODHM / ODHM
- Conditions
- Obesity, Diabete Type 2, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore influencing factors of diabetes remission and recovery of other complications after bariatric surgery. We design a multicenter study including respective cohort and prorespective cohort of obese patients treated with bariatric surgery or non-bariatric surgery，and collect clinical parameters and laboratory indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Procedure: Bariatric surgery, Other: Non-surgical threapy |
| Non-surgical group | – | Other: Non-surgical threapy |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obese patients treated with bariatric surgery or non-bariatric surgery(diet, exercise and weight loss drugs)
Key inclusion criteria (2 listed)
- Age range from 12 to 75 years,
- BMI (Body Mass Index) ≥ 25.0 kg/m2,
Key exclusion criteria (3 listed)
- Type 1 diabetes,
- Severe liver or kidney disease (eGFR < 30 ml/min), malignant tumors, endocrine disorders such as thyroid or Cushing's syndrome, acute coronary syndrome, uncontrolled heart failure, pregnancy or lactation, pancreatitis,
- Contraindications to other surgeries or medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryLaparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function | Procedure or surgery | Surgical group |
| Non-surgical threapyDiet management，exercise，metformin，GLP-1RA and other drugs which can lose weight. | Other | Non-surgical group, Surgical group |
Primary outcome
Total weight loss
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
13 secondary outcomes
Fasting blood glucose
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Average blood glucose from continuous glucose monitoring
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Postprandial 2-hour blood glucose
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
HbA1c
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Waist circumference and hip circumference
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Medication status
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Quality of life score
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
AHI
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
GERDQ Score
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Urinary microalbumin
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Serum creatinine
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
TC
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
TG
Time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Meng principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabete Type 2, run by China-Japan Friendship Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weight loss (time frame: 1st, 3rd, 6th and 12th month after intervention, respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.