Obesity Queue Database

Recruiting

• Conditions: Obesity

• Registration Number: NCT06391320
• Lead Sponsor: RenJi Hospital

Brief Summary

To establish an obesity specific disease cohort database and form a special disease cohort, so as to provide guarantee for carrying out high-quality real-world clinical research and clinical research.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2024-03-31
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Patients aged 18-75 years with simple obesity. Simple obesity diagnosis criteria: meet one of the following conditions

  1. BMI≥25 kg/m2
  2. Waist circumference for male/female ≥90/80 cm
  3. Waist-to-hip ratio: 0.9 (male); 0.85 (female)

Exclusion Criteria

• Patients aged 18-75 years with simple obesity. Simple obesity diagnosis criteria: meet one of the following conditions

  1. BMI≥25 kg/m2
  2. Waist circumference for male/female ≥90/80 cm
  3. Waist-to-hip ratio: 0.9 (male); 0.85 (female)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference	5 years	For a specialized outpatient clinic for obesity, follow-ups should be conducted at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. During the trial period and the post-trial observation period, relevant safety indicators must be documented, analyzed statistically, and reported.

Secondary Outcome Measures

Name	Time	Method
Intestinal flora components, glucagon, gastrointestinal hormones GLP-1 and GIP, inflammatory immune indicators, etc	5 years	For a specialized outpatient clinic for obesity, follow-ups should be conducted at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. During the trial period and the post-trial observation period, relevant safety indicators must be documented, analyzed statistically, and reported.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, China