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Clinical Trials/NCT06391320
NCT06391320RecruitingNot Applicable

Obesity Queue Database

RenJi Hospital1 site in 1 country5,000 target enrollmentStarted: September 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
5,000
Locations
1
Primary Endpoint
MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients aged 18-75 years with simple obesity. Simple obesity diagnosis criteria: meet one of the following conditions
  • •BMI≥25 kg/m2
  • •Waist circumference for male/female ≥90/80 cm
  • •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
  • •BMI≥25 kg/m2
  • •Waist circumference for male/female ≥90/80 cm
  • •Waist-to-hip ratio: 0.9 (male); 0.85 (female)

Outcomes

Primary Outcomes

MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference

Time Frame: 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 Outcomes

  • Intestinal flora components, glucagon, gastrointestinal hormones GLP-1 and GIP, inflammatory immune indicators, etc(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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