NCT03480945已完成不适用
Evaluation of the Mechanism Underlying Endothelial Dysfunction in Patients With Type 2 Diabetes With Poor and Optimized Glycaemic Control
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
Study objective To evaluate the mechanism behind endothelial dysfunction in patients with type 2 diabetes in relation to the level of glycaemic control.
Primary endpoint: Change in endothelium dependent vasodilatation (EDV).
详细描述
The study is performed on one group of patients with type 2 diabetes and one group of age-matched healthy controls
Inclusion criteria:
- Type 2 diabetes
- Poor glycaemic control defined as a mean day blood glucose >12 mmol/L.
Exclusion criteria:
- Age >80 years.
- HbA1c <70 mmol/mol
- Myocardial infarction/unstable angina within 6 weeks prior to the study.
- Treatment with oral anticoagulants (Warfarin or New oral anticoagulants)
- Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
- Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
- Participant in an ongoing study.
- Unwillingness to participate following oral and written information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes
- •Poor glycaemic control defined as a mean day blood glucose >12 mmol/L.
排除标准
- •Age >80 years.
- •HbA1c <70 mmol/mol
- •Myocardial infarction/unstable angina within 6 weeks prior to the study.
- •Treatment with oral anticoagulants (Warfarin or New oral anticoagulants)
- •Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
- •Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
- •Participant in an ongoing study.
- •Unwillingness to participate following oral and written information.
结局指标
主要结局
Endothelial function
时间窗: 8 weeks
Change in endothelium-dependent dilatation
次要结局
未报告次要终点
研究者
John Pernow
professor
Karolinska Institutet
研究点 (1)
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