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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04474535
Enrollment
200
Registered
2020-07-17
Start date
2020-03-03
Completion date
2021-12-31
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C-peptide, Diabetes Complications, Type 1 Diabetes

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.

Interventions

None listed

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years

Inclusion criteria

* Type 1 diabetes * Informed consent form

Exclusion criteria

* Known macrovascular complications * Known serious microvascular complications

Design outcomes

Primary

MeasureTime frameDescription
C-peptide concentrations1 dayConcentrations of plasma c-peptide in the fasting condition
Microvascular complications1 dayPresence of microvascular complications
Macrovascular complications1 dayPresence of macrovascular complications

Secondary

MeasureTime frameDescription
Association between c-peptide and complications1 dayPositive or negative association between c-peptide concentrations and presence of microvascular or macrovascular diabetes complications

Countries

Greece

Contacts

Primary ContactAlexandros Kokkinos
rjd@otenet.gr+302132061248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026