跳至主要内容
临床试验/NCT06391320
NCT06391320
招募中
不适用

Obesity Queue Database

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人2023年9月1日
适应症Obesity

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Obesity
发起方
RenJi Hospital
入组人数
5000
试验地点
1
主要终点
MRI-PDFF intraperitoneal fat content, fasting and postprandial blood glucose, insulin, C-peptide, glycated hemoglobin, body weight, waist circumference, hip circumference
状态
招募中
最后更新
2年前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2023年9月1日
结束日期
2028年12月31日
最后更新
2年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 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)

排除标准

  • 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)

结局指标

主要结局

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

时间窗: 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.

次要结局

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

研究点 (1)

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