Clinical trial NCT04474535: C-peptide Correlation With Microvascular Complications in T1DM
Official title: Association of β-cell Secretory Status With Early Microvascular and Macrovascular Complications in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
C-peptide
Diabetes Complications
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with type 1 diabetes followed in our Diabetes outpatient clinic

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Informed consent form

Exclusion Criteria:

* Known macrovascular complications
* Known serious microvascular complications

Primary outcomes:
measure: C-peptide concentrations
timeFrame: 1 day
measure: Microvascular complications
timeFrame: 1 day
measure: Macrovascular complications
timeFrame: 1 day
Secondary outcomes:
measure: Association between c-peptide and complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Study officials:
affiliation: First Department of Propaedeutic Medicine, University of Athens
name: Alexandros Kokkinos
role: PRINCIPAL_INVESTIGATOR
References: