Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 主要终点
- AUC75-120 of Glucose Infusion Rate (GIR)
研究概览
简要总结
It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25 to 60 years old
- •Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication.
- •Fasting blood glucose is above 11.0mmol/L.
- •Half of the patients with BMI below 24 and the other half with BMI above 24.
排除标准
- •type 1 diabetes mellitus
- •type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress)
- •Presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months.
结局指标
主要结局
AUC75-120 of Glucose Infusion Rate (GIR)
时间窗: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
次要结局
- AUC0-10 of Acute Insulin Response (AIR) during IVGTT(after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments)
研究者
Li Guangwei
Professor
China-Japan Friendship Hospital
