- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451938
A Cohort Study on Obese Patients' Multidisciplinary Integrated Health Management (ODHM)
February 28, 2026 updated by: Hua Meng, China-Japan Friendship Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China
- China-Japan Friendship Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Obese patients treated with bariatric surgery or non-bariatric surgery(diet, exercise and weight loss drugs)
Description
Inclusion Criteria:
- Age range from 12 to 75 years,
- BMI (Body Mass Index) ≥ 25.0 kg/m2,
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-surgical group
|
Diet management,exercise,metformin,GLP-1RA and other drugs which can lose weight.
|
|
Surgical group
|
Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function
Diet management,exercise,metformin,GLP-1RA and other drugs which can lose weight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total weight loss
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum creatinine
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
Fasting blood glucose
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
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.
|
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.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
HbA1c
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
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.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
Medication status
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
Quality of life score
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
AHI
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
GERDQ Score
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
Urinary microalbumin
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
TC
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
|
TG
Time Frame: 1st, 3rd, 6th and 12th month after intervention, respectively.
|
1st, 3rd, 6th and 12th month after intervention, respectively.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hua Meng, China-Japan Friendship Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
July 30, 2025
Study Completion (Actual)
July 30, 2025
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
February 28, 2026
First Posted (Actual)
March 5, 2026
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
February 28, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Diabetes Mellitus, Type 2
- Therapeutics
- Surgical Procedures, Operative
- Bariatrics
- Obesity Management
- Bariatric Surgery
Other Study ID Numbers
- ODHM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.