NCT06661174招募中不适用
A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy
China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total weight loss
研究概览
简要总结
Establish a cohort of diabetic kidney disease(DKD) patients with intensive weight loss treatment to evaluate the impact of intensive weight loss treatment on the renal prognosis of DKD and construct a prediction model for the improvement of renal outcomes after weight loss.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years old;
- •BMI>25Kg/m2 or abdominal obesity (i.e. waist circumference>90cm for men and>85cm for women);
- •eGFR<30ml/min/1.73m2 or urinary microalbumin≥300mg/g, eGFR<60ml/min/1.73m2.
排除标准
- •Patients who are taking glucocorticoids;
- •Combined with tumors; ③Combined with autoimmune diseases; ④Serum albumin<25g/L.
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
- Serum creatinine(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Glomerular filtration rate(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.)
- HbA1c(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Waist circumference and hip circumference(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Urinary microalbumin and other Urinalysis indexes(1st, 3rd, 6th and 12th month after intervention, respectively.)
- Medication status(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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