NCT02231736Unknown不适用
Incidence of Chromosomal Damage in Type 2 Diabetes Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The quality of HbA1c influences micronuclei formation in binucleated cells
研究概览
简要总结
The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes (T2DM)
- •Sex: female
- •Age: > 30years
- •Medication: oral anti-diabetics and/or Insulin therapy
- •Constant nutritional behavior, constant physical activity, constant weight for the last 4 weeks
- •Non-smoking for at least 1 year
排除标准
- •Patients with type 1 DM
- •Age: < 30years
- •Pregnant or lactating women
- •Participation in another clinical trial
- •Change of medication in regard to metabolic parameters within the last 4 weeks
- •Significant cardiovascular damage with NYHA > III
- •Liver disease with three-times higher transaminase values
- •Chronic kidney disease with serum creatinine > 2 mg/dl
- •HIV positive
- •History of chronic alcohol abuse in the last two years
- •History of cancer, stroke, organ transplantation
结局指标
主要结局
The quality of HbA1c influences micronuclei formation in binucleated cells
时间窗: Baseline
In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c\<7.5%) and a high (HbA1c\>7.5%) glycemic group
次要结局
- Type 2 diabetes duration of the subjects influences chromosomal damage(Baseline)
研究者
Karl-Heinz Wagner
Director Research Platform Active Ageing
University of Vienna
研究点 (1)
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