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临床试验/CTRI/2012/01/002379
CTRI/2012/01/002379招募中3 期

Effect of short term versus extended period early intensive conventional insulin therapy on beta cell function, insulin resistance, glycemic control and long term remission rate in newly diagnosed type 2 diabetes: a randomized parallel group trial

CSIR NewDelhi0 个研究点目标入组 220 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
220

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Newly diagnosed T2DM patients (treatment naïve, less than six months since diagnosis) of both sexes aged 25-65 years who have failed to diet and exercise therapy alone (diagnosis would be based on American Diabetes Association recommendations)
  • 2.Willing to give informed consent after explaining the purpose, nature and potential risks of the study

排除标准

  • 1.Acute or severe chronic diabetic complications
  • 2.Severe intercurrent illness(the condition or the treatment there of is likely to affect the study outcomes)
  • 3.Impaired renal functions (S. Creatinine 1.5 mg% in males and 1.4 mg% in females)
  • 4.Impaired hepatic functions (Serum bilirubin, SGOT, SGPT, and Alkaline phosphatase 1.5 times the upper limit of normal)
  • 5.Tested positive for glutamic acid decarboxylase antibody
  • 6.Maturity onset diabetes in youth (exclusion by history)
  • 7.Patients requiring 1.3U/kg body weight of insulin at the end of titration phase.
  • 8.Pregnancy / lactation
  • 9.Malignancy (previously documented)
  • 10.Ischemic heart disease (previously documented)

研究者

发起方
CSIR NewDelhi

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