A Cohort Study on Obese Patients' Multidisciplinary Integrated Health Management

NCT07451938 | Completed

• 1 other identifier: ODHM
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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 indicators.

Conditions

Obesity; Diabete Type 2; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Total weight loss

  1st, 3rd, 6th and 12th month after intervention, respectively.

Secondary Outcomes (13)

• Fasting blood glucose

  1st, 3rd, 6th and 12th month after intervention, respectively.

• Average blood glucose from continuous glucose monitoring

  1st, 3rd, 6th and 12th month after intervention, respectively.

• Postprandial 2-hour blood glucose

  1st, 3rd, 6th and 12th month after intervention, respectively.

• HbA1c

  1st, 3rd, 6th and 12th month after intervention, respectively.

• Waist circumference and hip circumference

  1st, 3rd, 6th and 12th month after intervention, respectively.

Study Arms (2)

Surgical group

Procedure: Bariatric surgery; Other: Non-surgical threapy

Non-surgical group

Other: Non-surgical threapy

Interventions

Bariatric surgery PROCEDURE

Laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on β-cell function

Surgical group

Non-surgical threapy OTHER

Diet management，exercise，metformin，GLP-1RA and other drugs which can lose weight.

Non-surgical group; Surgical group

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients treated with bariatric surgery or non-bariatric surgery(diet, exercise and weight loss drugs)

You may qualify if:

• Age range from 12 to 75 years,
• BMI (Body Mass Index) ≥ 25.0 kg/m2,

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hua Meng

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: March 5, 2026
• Study Start: July 1, 2017
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: March 5, 2026

Record last verified: 2025-11

Locations

CN (1)