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临床试验/ACTRN12619001440112
ACTRN12619001440112已完成3 期

Effect of metformin on hepatic and peripheral insulin resistance in adults with type 1 diabetes: protocol of a double-blind placebo controlled, randomised trial

Garvan Institute of Medical Research0 个研究点目标入组 60 人开始时间: 2019年10月17日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
20 Years 至 55 Years(—)
性别
All

入选标准

  • T1D and controls without diabetes:
  • 1. Age: adult (ages 20-55)
  • 2. Premenopausal (if female)
  • 1. < 10 years since diagnosis of diabetes
  • 2. Fasting c-peptide < 0.3nmol/L)
  • 3. HbA1c less than or equal to 9.5%

排除标准

  • 1. Current smoking
  • 2. Current or planned prescription of medications that affect glucose metabolism (glucocorticoids, antipsychotics, immunosuppressants).
  • 3. Exposure to metformin within the last 30 days
  • 4. Alcohol intake > 20g/day in women or > 40g/day in men
  • 5. Weight change > 5% in last 3 months or history of bariatric surgery
  • 6. Pregnancy, breastfeeding, or childbearing potential not willing to avoid pregnancy during the study
  • 7. Known major organ dysfunction (eGFR < 60, liver disease transaminases > 3 times the upper limit of normal, cardiac event within the last 6 months, current cancer or uncontrolled thyroid dysfunction).
  • 8. Diabetic ketoacidosis or severe hypoglycaemia (hypoglycaemia requiring third-party assistance) in the last 6 months.
  • 9. A history of a psychological illness or condition that would interfere with the patient’s ability to understand the requirements of the study.

研究者

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