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临床试验/NCT01588743
NCT01588743Unknown不适用

Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients

Li Guangwei0 个研究点目标入组 130 人开始时间: 2008年10月1日最近更新:
适应症
相关药物

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

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

发起方
Li Guangwei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Li Guangwei

Professor

China-Japan Friendship Hospital

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