Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells in Patients With Type 2 Diabetes: a Partially Double-Blind, Randomized, Three-Arm Unicenter Study
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis
研究概览
简要总结
In this trial, it will be studied whether early addition of the long acting insulin analogue Glargine is capable of increasing the number and differentiation of endothelial progenitor cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. In addition, the effect of Glargine on microvascular function will be studied. This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •Oral antidiabetic therapy
- •Age 35 - 70
- •6,5%< HbA1c ≤ 9%
- •Ability of subject to understand character and individual consequences of clinical trial
- •Written informed consent must be available before enrollment in the trial
- •For women with childbearing potential, adequate contraception (Pearl Index < 1%, e.g. birth control pill) and negative blood pregnancy test
- •6,5%< HbA1c ≤ 9%
- •Ability of subject to understand character and individual consequences of clinical trial
- •Written informed consent must be available before enrollment in the trial
- •For women with childbearing potential, adequate contraception (Pearl Index < 1%, e.g. birth control pill) and negative blood pregnancy test
排除标准
- •Malignant disease
- •Hematopoietic disorders
- •Impairment of renal function (Serum creatinine > 1,5mg/dl)
- •autoimmune disease
- •treatment with immunosuppressive drugs
- •Psychiatric disease
- •Myocardial ischemia during previous 6 month
- •Acute coronary syndrome
- •pAVK IIb, III, IV (Fontaine-Ratschow)
- •Erythropoietin treatment
- •Glitazone treatment during two weeks before inclusion
- •Insulin treatment during two weeks before inclusion
- •Pregnancy and lactation
- •History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
- •Participation in other clinical trials and observation period of competing trials, respectively
- •No subject will be allowed to enroll in this trial more than once.
研究组 & 干预措施
2
干预措施: Insulin Glargin (Drug)
3
干预措施: Human Insulin (Drug)
结局指标
主要结局
Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis
时间窗: 4 weaks of treatment
次要结局
- Change of number of circulating EPC 4 as detected by in vitro outgrowth(4 weeks, 4 months)
- Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)(4 months)
- Myocardial function and myocardial perfusion reserve as measured by MRI(4 months)
- Intima-Media-Thickness(4 months)
- Long-term Glucose control (HbA1c)(4 weeks, 4 months)
- Short-term Glucose control (fasting glucose)(4 weeks, 4 months)
- Markers of inflammation and vascular risk in diabetes(4 weeks, 4 months)