C-peptide Correlation With Microvascular Complications in T1DM
NCT ID: NCT04474535
Last Updated: 2020-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-03-03
2021-12-31
Brief Summary
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Detailed Description
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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).
All data will be recorded in an electronic database for statistical processing.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Informed consent form
Exclusion Criteria
* Known serious microvascular complications
15 Years
70 Years
ALL
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Alexandros Kokkinos
Associate Professor in Internal Medicine
Principal Investigators
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Alexandros Kokkinos
Role: PRINCIPAL_INVESTIGATOR
First Department of Propaedeutic Medicine, University of Athens
Locations
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Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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T1DM C-peptide
Identifier Type: -
Identifier Source: org_study_id
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