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临床试验/NCT04474535
NCT04474535Unknown不适用

Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年3月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
C-peptide concentrations

研究概览

简要总结

The purpose of this study is to investigate the presence of residual insulin secretion in patients with DM1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.

详细描述

The study will include approximately 200 patients, male and female, with DM1 who are being followed in the outpatient diabetic clinic of our hospital.

Each patient will visit the Research Laboratory of the Diabetes Centre of our Department. The visit will take place in the morning in a fasting state of about 12 hours. Demographic data will be recorded along with the patients' habits, lifestyle, current medication and complete medical history of concomitant diseases.

This will be followed by anthropometric measurements (weight, height, BMI) and afterwards blood samples will be taken for the determination of urea, creatinine, glucose, HbA1c and lipids. Part of each blood sample will be collected in tubes containing EDTA to determine fasting c-peptide concentrations. The presence of microalbuminuria will be assessed from a morning urine sample by calculating urinary albumin to creatinine ratio (ACR).

The functionality of the heart's autonomic nervous system will be assessed through the use of heart rate variability (HRV) measurements, using the standard Ewing's tests panel: deep inhalation, standing up and Valsalva's manoeuvre. Changes in blood pressure when changing from the supine to the standing position will also be recorded. Subsequently, the distensibility of the large vessels will be determined, by calculating the conduction velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity (PWV)).

Finally, a full transthoracic echocardiographic study will be carried out to assess functionality, systolic and diastolic, of the left ventricle (LV).

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
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 1 diabetes
  • Informed consent form

排除标准

  • Known macrovascular complications
  • Known serious microvascular complications

结局指标

主要结局

C-peptide concentrations

时间窗: 1 day

Concentrations of plasma c-peptide in the fasting condition

Macrovascular complications

时间窗: 1 day

Presence of macrovascular complications

Microvascular complications

时间窗: 1 day

Presence of microvascular complications

次要结局

  • Association between c-peptide and complications(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandros Kokkinos

Associate Professor in Internal Medicine

National and Kapodistrian University of Athens

研究点 (1)

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