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

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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D007239 Infection NIH 0.06

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There is one clinical trial.

Clinical Trials


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

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.

NCT04463849 COVID19 BETA-CELL FUNCTION Diagnostic Test: Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection
MeSH:Infection

Primary Outcomes

Description: Difference in insulin levels during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function index insulin levels

Time: 12 months

Description: Difference in C-peptide levels during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function index C-peptide levels

Time: 12 months

Description: Difference in HOMA-β index during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function HOMA-β index

Time: 12 months

Description: Difference in pro-insulin/insulin ratio during and after COVID-19 infection and compared to patients in the control group

Measure: Serum β - cellular function pro-insulin/insulin ratio

Time: 12 months

Description: Check for the existence of damage to the beta cell function induced by COVID-19 infection, clinically observable with changes in the secretory response of insulin

Measure: Evaluation of the secretory response of insulin to the arginine stimulation test

Time: 12 months

Description: Presence of SARS-CoV-2 viral particles in β cells in COVID-19 patient samples

Measure: Viral SARS-CoV-2 particles in β cells

Time: 12 months

Description: Evidence of impairment of β cell function in the serum of COVID-19 patients

Measure: Percentage of patients with preserved β cells function

Time: 12 months

Secondary Outcomes

Description: Changes in glucose values in COVID-19 patients and healthy volunteers

Measure: Glucose values

Time: 12 months

Description: Changes in the values of continuous glucose monitoring in both COVID-19 patients and healthy volunteers

Measure: Values of continuous glucose monitoring

Time: 12 months

Description: Comparison of interleukin 1-β levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin 1-β

Time: 12 months

Description: Comparison of interleukin IL-2 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-2

Time: 12 months

Description: Comparison of interleukin IL-6 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-6

Time: 12 months

Description: Comparison of interleukin IL-7 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-7

Time: 12 months

Description: Comparison of interleukin IL-10 levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interleukin IL-10

Time: 12 months

Description: Comparison of interleukin tumor necrosis factor-α levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker tumor necrosis factor-α

Time: 12 months

Description: Comparison of interferon gamma levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker interferon gamma

Time: 12 months

Description: Comparison of macrophage inflammatory protein-1β levels in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker macrophage inflammatory protein-1β

Time: 12 months

Description: Comparison of macrophage inflammatory monocyte chemoattractant protein-1 in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker monocyte chemoattractant protein-1

Time: 12 months

Description: Comparison of macrophage inflammatory granulocyte-macrophage colony-stimulating factor in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker granulocyte-macrophage colony-stimulating factor

Time: 12 months

Description: Comparison of macrophage inflammatory granulocyte colony-stimulating factor in COVID-19 patients compared with healthy subjects

Measure: Changes in the inflammatory marker granulocyte colony-stimulating factor

Time: 12 months


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