EUCTR2006-002638-39-GB进行中(未招募)不适用
Mechanisms responsible for cardiac and skeletal muscle energetic impairment in type 1 diabetes
niversity Hospitals of Birmingham NHS Foundation Trust0 个研究点目标入组 60 人开始时间: 2006年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Type I diabetes (WHO definition)
- •2.HbA1C <9,
- •3.No history of chest pain and no evidence of CAD or peripheral vascular disease
- •4.Left ventricular ejection fraction over 50%
- •5.No evidence of respiratory disease.
- •Group1 with diagnosis in the last 3 years and no evidence of microvascular disease.
- •Group 2 with 10-15 years since diagnosis (but age matched) and evidence of coronary microvascular dysfunction.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients < 16years or who cannot provide informed consent
- •2.Evidence of significant epicardial coronary artery disease
- •3.Evidence of peripheral vascular disease
- •4.Abnormal liver function tests
- •5.Clinically apparent peripheral neuropathy (for Perhexiline intervention study)
- •6.Severe chronic renal failure (creatinine >250) or diabetic nephropathy
- •7.Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
- •8.Patients on statin therapy for primary dyslipidemia.
- •9.Patients with recurrent hypoglycaemia
- •10.Women of child bearing age who are not using effective contraception (or if pregnancy test positive)
研究者
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