CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infectionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04463849
NCT04463849N/ACompleted

Effects of SARS-CoV-2 Infection on Beta-cell Function in Euglycemic Patients

University of Milan·interventional·Posted Jul 9, 2020·Updated May 10, 2023

In Brief

A clinical study evaluating Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection for COVID19 and BETA-CELL FUNCTION. Completed, enrolled 90 participants across 1 site.

Detailed Summary

In recent months, a new coronavirus, SARS-CoV-2, has been identified as the cause of a serious lung infection named COVID-19 by the World Health Organization. This virus has spread rapidly among the nations of the world and it is the cause of a pandemic and a global health emergency. There is still very little scientific evidence on the virus, however epidemiological data suggest that one of the most frequent comorbidities is diabetes, along with hypertension and heart disease. There is no scientific evidence on the possible effects of this infection on the function of the β cell and on glycemic control. Clinical evidence seems to suggest that COVID-19 infection mostly affects the respiratory system, and an acute worsening of glycemic compensation is not described as generally observed in bacterial pneumonia. However, previous work on acute respiratory syndromes (SARS) caused by similar coronaviruses, had described that the infection has multi-organ involvement related to the expression of the SARS coronavirus receptor, the angiotensin 2 converting enzyme, in different organs, especially at the level of endocrine pancreatic tissue. In the population of this previous work, glucose intolerance and fasting hyperglycaemia have been described and in 37 of 39 diabetic patients examined, a remission of diabetes was observed three years after the infection. It is possible that the coronaviruses responsible for SARS may enter the pancreatic islets using the angiotensin 2 converting enzyme receptor, expressed at the level of the endocrine pancreas, thus causing diabetes. Additionally, previous literature on coronavirus infections (SARS and MERS or Middle-East Respiratory Syndrome) suggested that diabetes could worsen the evolution of the disease. In particular, in case of Middle-East Respiratory Syndrome-CoV infection, diabetic mice had a more prolonged serious illness and a delay in recovery regardless of the viremic titer. This could probably be due to a dysregulation of the immune response, which results in more serious and prolonged lung disease. There are currently no data on pancreatic beta cell function in patients with COVID-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 9, 2020
Enrollment StartJun 30, 2020
Primary CompletionOct 31, 2021
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.0 years ago

Interventions

Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infectionother

All participants will be subjected to the collection of glycemic data through continuous professional retrospective monitoring of blood glucose for seven days, positioned on the day the test will be performed. During the entire recording period, parameters such as mean glucose, estimated glycosylated hemoglobin, peak glucose and nadir, blood sugar levels above the limit of 140 mg / dL, average glucose values at 60 and 120 minutes after meals, standard deviation and variability coefficient. The evaluation of insulin secretion will be evaluated by performing the stimulus test with arginine infusion according to validated protocols.