- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474535
C-peptide Correlation With Microvascular Complications in T1DM
Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus
Study Overview
Status
Conditions
Detailed Description
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).
All data will be recorded in an electronic database for statistical processing.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alexandros Kokkinos
- Phone Number: +302132061248
- Email: rjd@otenet.gr
Study Locations
-
-
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Athens, Greece, 11527
- Recruiting
- Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Type 1 diabetes
- Informed consent form
Exclusion Criteria:
- Known macrovascular complications
- Known serious microvascular complications
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-peptide concentrations
Time Frame: 1 day
|
Concentrations of plasma c-peptide in the fasting condition
|
1 day
|
Microvascular complications
Time Frame: 1 day
|
Presence of microvascular complications
|
1 day
|
Macrovascular complications
Time Frame: 1 day
|
Presence of macrovascular complications
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between c-peptide and complications
Time Frame: 1 day
|
Positive or negative association between c-peptide concentrations and presence of microvascular or macrovascular diabetes complications
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexandros Kokkinos, First Department of Propaedeutic Medicine, University of Athens
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1DM C-peptide
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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