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NCT Number: NCT06391320

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

other

Other

Observational studies do not involve intervention

Primary outcomes

  1. 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

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

    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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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