NCT06391320

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2023Dec 2028

Study Start

First participant enrolled

September 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

5.3 years

First QC Date

March 31, 2024

Last Update Submit

April 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    5 years

Interventions

otherOTHER

Observational studies do not involve intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 30, 2024

Study Start

September 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations