NCT02325271已完成不适用
Intra-individual Variability and Circadian Rhythm of Systemic Vascular Endothelial Growth Factor (VEGF) Levels and Interaction With Biomarkers of Inflammation in Subjects With Normal Glucose Tolerance (NGT) and Patients With Type 2 Diabetes Without Diabetic Macular Edema (DME)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VEGF-C
研究概览
简要总结
The study evaluates the intra-individual variability of VEGF levels over a period of 6 months as well as the circadian variation of VEGF levels, both under standardized conditions in patients with type 2 diabetes without DME and matched subjects with normal glucose tolerance (NGT). Secondary objectives of the study are to evaluate the relationship of individual VEGF-levels to biomarkers of inflammation, HbA1c and major cardiovascular risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age equal to or between 50 and 80 years
- •Subjects with normal glucose tolerance confirmed by glucose tolerance test (control group) or patients with type 2 diabetes: diabetes duration 5-25 years; HbA1c equal to or between 6.5 and 9% (diabetes group)
- •Ability to understand and follow study-related instructions
排除标准
- •hsCRP > 10 mg/dl
- •Acute infections
- •Acute or chronic inflammatory diseases
- •Immune diseases
- •Treatment with immune suppressive drugs
- •Treatment with glucocorticoids
- •Myocardial infarction and stroke within 1 year before inclusion
- •Hemorrhage within the previous 5 years
- •Surgeries within the previous 3 months
- •Oncological diseases
- •Women who are pregnant or breast-feeding
结局指标
主要结局
VEGF-C
时间窗: Hourly over 12 hours
Plasma levels determined over the day
VEGF-A
时间窗: Hourly over 12 hours
Plasma levels determined over the day
VEGF-B
时间窗: Hourly over 12 hours
Plasma levels determined over the day
Placental growth factor
时间窗: Hourly over 12 hours
Plasma levels determined over the day
次要结局
- Cystatin C(Hourly over 12 hours)
- Glycated hemoglobin (HbA1c)(Baseline, month 1, 2, 3, 4, 5 and 6)
- Albumin(Baseline, month 1, 2, 3, 4, 5 and 6)
- Blood pressure(Baseline, month 1, 2, 3, 4, 5 and 6, once over 24 hours)
- High-sensitivity C-reactive protein (hCRP)(Baseline, month 1, 2, 3, 4, 5 and 6)
- MMP-9(Hourly over 12 hours)
- Adiponectin(Hourly over 12 hours)
- Matrix metallopeptidase 9 (MMP-9)(Baseline, month 1, 2, 3, 4, 5 and 6)
- Creatinine(Baseline, month 1, 2, 3, 4, 5 and 6)
研究者
研究点 (1)
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