NCT07451938已完成不适用
A Cohort Study on Obese Patients' Multidisciplinary Integrated Health Management
China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Total weight loss
研究概览
简要总结
To explore influencing factors of diabetes remission and recovery of other complications after bariatric surgery. We design a multicenter study including respective cohort and prorespective cohort of obese patients treated with bariatric surgery or non-bariatric surgery，and collect clinical parameters and laboratory indicators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 12 to 75 years,
- •BMI (Body Mass Index) ≥ 25.0 kg/m2,
排除标准
- •Type 1 diabetes,
- •Severe liver or kidney disease (eGFR < 30 ml/min), malignant tumors, endocrine disorders such as thyroid or Cushing's syndrome, acute coronary syndrome, uncontrolled heart failure, pregnancy or lactation, pancreatitis,
- •Contraindications to other surgeries or medications.
研究组 & 干预措施
Surgical group
干预措施: Non-surgical threapy (Other)
Non-surgical group
干预措施: Non-surgical threapy (Other)
Surgical group
干预措施: Bariatric surgery (Procedure)
结局指标
主要结局
Total weight loss
时间窗: 1st, 3rd, 6th and 12th month after intervention, respectively.
次要结局
- HbA1c(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Waist circumference and hip circumference(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Medication status(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Quality of life score(1st, 3rd, 6th and 12th month after intervention, respectively.)
- AHI(1st, 3rd, 6th and 12th month after intervention, respectively.)
- GERDQ Score(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Urinary microalbumin(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Serum creatinine(1st, 3rd, 6th and 12th month after intervention, respectively.)
- TC(1st, 3rd, 6th and 12th month after intervention, respectively.)
- TG(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Fasting blood glucose(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Average blood glucose from continuous glucose monitoring(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Postprandial 2-hour blood glucose(1st, 3rd, 6th and 12th month after intervention, respectively.)
研究者
Hua Meng
Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital
China-Japan Friendship Hospital
研究点 (1)
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