NCT04469400已完成不适用
Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation
Second Affiliated Hospital, School of Medicine, Zhejiang University8 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2020年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 8
- 主要终点
- Fasting blood glucose
研究概览
简要总结
Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 是
入选标准
- •Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL)
- •24 kg/m2 ≤ BMI ≤ 35 kg/m2
- •Those who are willing to accept assessment and sign informed consent.
排除标准
- •Patients diagnosed with diabetes or undergoing diabetes treatment;
- •Receiving drugs or surgery for weight loss at present or in the past 3 months;
- •Receiving corticosteroid or thyroid hormone treatment;
- •Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases;
- •Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake;
- •Diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ Suffering from infectious diseases such as active tuberculosis and AIDS; ⑨ During pregnancy or lactation; ⑩Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.
结局指标
主要结局
Fasting blood glucose
时间窗: ten weeks
Blood glucose 2 hours after meal
时间窗: ten weeks
次要结局
未报告次要终点
研究者
研究点 (8)
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