Obesity Queue Database

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: other

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Jing Ma; Phone Number: +86 158 0098 3436; Email: cherry1996@live.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
    • Contact: Jiang Yue; Phone Number: +86 189 1815 2626; Email: rjnfm3083@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with obesity, aged 18-75 years, who met the diagnostic criteria for simple obesity and did not participate in any drug clinical trials within 3 months prior to inclusion.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal flora components, glucagon, gastrointestinal hormones GLP-1 and GIP, inflammatory immune indicators, etc	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.	5 years

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: LY2023-212-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No