Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623697
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2020-11-09
Brief Title:
Covid-19 Infection and New Onset Type 1 Diabetes
Sponsor:
Hospital of South West Jutland
Organization:
Hospital of South West Jutland
Study Overview
Official Title:
Covid-19 and Type 1 Diabetes - a Multicenter Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although recognized as an autoimmune disease the etiology of type 1 diabetes remains unknown Virus infections has been suggested as a possible agent triggering the autoimmune reaction finally resulting in beta-cell destruction and fate of insulin secretion SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor which is abundant in many tissues including the pancreas Accordingly SARS Covid-19 infection may trigger the development of type 1 diabetes either by an activation of the immune system or directly via beta-cell infection and destruction
Our aim is to study the impact of the Covid-19 epidemic on the development of type 1 diabetes This will be done in two ways a clinical study and an epidemiological follow up During the next two years adult patients with newly diagnosed type 1 diabetes will be asked to participate Type 1 diabetes will be diagnosed by usual means and a mixed meal tolerance test will be performed at time of diagnosis and after one year to evaluate beta-cell function People with type 1 diabetes and serologically documented previous SARS Covid-19 will be compared with people with no previous infection regarding beta-cell function and fate of insulin secretion In addition we will estimate the number of new diagnosed type 1 diabetes patients compared to previous years
Our aim is to study the impact of the Covid-19 epidemic on the development of type 1 diabetes This will be done in two ways a clinical study and an epidemiological follow up During the next two years adult patients with newly diagnosed type 1 diabetes will be asked to participate Type 1 diabetes will be diagnosed by usual means and a mixed meal tolerance test will be performed at time of diagnosis and after one year to evaluate beta-cell function People with type 1 diabetes and serologically documented previous SARS Covid-19 will be compared with people with no previous infection regarding beta-cell function and fate of insulin secretion In addition we will estimate the number of new diagnosed type 1 diabetes patients compared to previous years
Detailed Description:
Background
Although recognized as an autoimmune disease the etiology of type 1 diabetes mellitus T1D remains undetermined One dominant hypothesis is that a recent virus infection elicits or enhances an autoimmune reaction resulting in CD4 and CD8 T-cells recognizing pancreatic antigens and subsequently targeting the beta-cells of the pancreas This results in a gradual but irreversible loss of beta-cell function
Various enterovirus species have been suspected as causative factors of T1D However many different viruses may carry the potential to induce T1D via one of the above-mentioned mechanisms including respiratory infections
Most people are presently immunologically inert to SARS-Cov-2 but a large proportion of the worlds population is expected to be infected over the next few years with the global focus having now shifted to slowing the spread 1 The pandemic of COVID-19 therefore provides an opportunity to study a possible correlation between a novel type of virus infection and the development of T1D
Aim
Our overall aim is to study the impact of Covid-19 on the incidence and the phenotype beta-cell function at time of diagnosis and at follow up of newly diagnosed adult patients with T1D in a multicenter study with enrolments to occur in both Denmark and Portugal
Method
The following study populations are established over a two-year period beginning in October 2020
1 Study population 1 Newly diagnosed adult patients with T1D according to usual practice stratified for the presence of SARS-Cov-2-antibodies - in both Denmark and Portugal
2 Study population 2 A control population of the same age - 3 years and sex from each participant country potentially from the national blood banks This will provide the SARS-Cov-2 status of the background population Each newly diagnosed T1D patient is matched with five control persons
Study 1 Clinical study Study 1
Inclusion criteria
T1D patients diagnosed according to standard practice including Hba1c C-peptide presence of GAD or islet-cell antibodies
Patient is attending a hospital unit in Denmark or Portugal due to T1D
Age 18 years or above
Exclusion criteria
- Severe psychiatric disorder or other conditions deemed to impair the patients informed consent and participation in the study
In each country all subjects from study population 1 will undergo the following assessments at diagnosis of T1D
1 SARS-Cov-2 antibody measurement
2 GAD-antibodies and if necessary islet cell antibodies IA-2
3 HbA1c fasting blood glucose and fasting C-peptide
4 Mixed-meal tolerance test MMTT
5 Follow-up one year after the diagnosis with HbA1c fasting blood glucose fasting C-peptide and MMTT
Study 2 Epidemiological study 1 In each country the incidence of SARS-Covid-2 antibodies in study group 1 is compared to the matched control group Study population 2
Study 3 Epidemiological study 2 Independently of the above mentioned study the incidence of newly diagnosed T1D patients in each participant country will be determined by registry data from January 1st 2020 on a monthly basis and compared with newly diagnosed T1D patients from the two previous years 2018 and 2019
Outcomes
The study will have the following outcomes
Study 1 clinical study
Primary outcome C-peptide AUC of the MMTT at baseline and one year follow-up for adult T1D patients having SARS-Cov-2 positive vs negative antibody status
Secondary outcomes Fasting glucose C-peptide Hba1c at baseline and one year follow-up for adult T1D patients having SARS-Cov-2 positive vs negative antibody status
Study 2 epidemiological study 1
Outcome Proportion of T1D patients having SARS-Cov-2 antibodies compared to matched controls from the background population potentially from the national blood banks 15 match on age gender and if possible country region
Study 3 epidemiological study 2
Outcome Annual and monthly T1D incidence cases100000 during 2020-2022 compared to 2018 and 2019 in Denmark and Portugal
Although recognized as an autoimmune disease the etiology of type 1 diabetes mellitus T1D remains undetermined One dominant hypothesis is that a recent virus infection elicits or enhances an autoimmune reaction resulting in CD4 and CD8 T-cells recognizing pancreatic antigens and subsequently targeting the beta-cells of the pancreas This results in a gradual but irreversible loss of beta-cell function
Various enterovirus species have been suspected as causative factors of T1D However many different viruses may carry the potential to induce T1D via one of the above-mentioned mechanisms including respiratory infections
Most people are presently immunologically inert to SARS-Cov-2 but a large proportion of the worlds population is expected to be infected over the next few years with the global focus having now shifted to slowing the spread 1 The pandemic of COVID-19 therefore provides an opportunity to study a possible correlation between a novel type of virus infection and the development of T1D
Aim
Our overall aim is to study the impact of Covid-19 on the incidence and the phenotype beta-cell function at time of diagnosis and at follow up of newly diagnosed adult patients with T1D in a multicenter study with enrolments to occur in both Denmark and Portugal
Method
The following study populations are established over a two-year period beginning in October 2020
1 Study population 1 Newly diagnosed adult patients with T1D according to usual practice stratified for the presence of SARS-Cov-2-antibodies - in both Denmark and Portugal
2 Study population 2 A control population of the same age - 3 years and sex from each participant country potentially from the national blood banks This will provide the SARS-Cov-2 status of the background population Each newly diagnosed T1D patient is matched with five control persons
Study 1 Clinical study Study 1
Inclusion criteria
T1D patients diagnosed according to standard practice including Hba1c C-peptide presence of GAD or islet-cell antibodies
Patient is attending a hospital unit in Denmark or Portugal due to T1D
Age 18 years or above
Exclusion criteria
- Severe psychiatric disorder or other conditions deemed to impair the patients informed consent and participation in the study
In each country all subjects from study population 1 will undergo the following assessments at diagnosis of T1D
1 SARS-Cov-2 antibody measurement
2 GAD-antibodies and if necessary islet cell antibodies IA-2
3 HbA1c fasting blood glucose and fasting C-peptide
4 Mixed-meal tolerance test MMTT
5 Follow-up one year after the diagnosis with HbA1c fasting blood glucose fasting C-peptide and MMTT
Study 2 Epidemiological study 1 In each country the incidence of SARS-Covid-2 antibodies in study group 1 is compared to the matched control group Study population 2
Study 3 Epidemiological study 2 Independently of the above mentioned study the incidence of newly diagnosed T1D patients in each participant country will be determined by registry data from January 1st 2020 on a monthly basis and compared with newly diagnosed T1D patients from the two previous years 2018 and 2019
Outcomes
The study will have the following outcomes
Study 1 clinical study
Primary outcome C-peptide AUC of the MMTT at baseline and one year follow-up for adult T1D patients having SARS-Cov-2 positive vs negative antibody status
Secondary outcomes Fasting glucose C-peptide Hba1c at baseline and one year follow-up for adult T1D patients having SARS-Cov-2 positive vs negative antibody status
Study 2 epidemiological study 1
Outcome Proportion of T1D patients having SARS-Cov-2 antibodies compared to matched controls from the background population potentially from the national blood banks 15 match on age gender and if possible country region
Study 3 epidemiological study 2
Outcome Annual and monthly T1D incidence cases100000 during 2020-2022 compared to 2018 and 2019 in Denmark and Portugal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None