NCT04623697

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

4.2 years

First QC Date

November 9, 2020

Last Update Submit

October 23, 2023

Conditions

Covid19type1diabetes

Keywords

Covid19Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Stimulated insulin secretion

    C-peptide AUC of the MMTT at baseline and one year follow-up

    One years

Secondary Outcomes (2)

  • HbA1c

    One years

  • Fasting blood glucose

    One years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All newly diagnosed people with type 1 diabetes

You may qualify if:

  • 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.

You may not qualify if:

  • Severe psychiatric disorder or other conditions deemed to impair the patient's informed consent and participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of South West Jutland

Esbjerg, 6700, Denmark

RECRUITING

Related Publications (10)

  • Filippi CM, von Herrath MG. Viral trigger for type 1 diabetes: pros and cons. Diabetes. 2008 Nov;57(11):2863-71. doi: 10.2337/db07-1023. No abstract available.

    PMID: 18971433RESULT

  • Coleman TJ, Gamble DR, Taylor KW. Diabetes in mice after Coxsackie B 4 virus infection. Br Med J. 1973 Jul 7;3(5870):25-7. doi: 10.1136/bmj.3.5870.25.

    PMID: 4577716RESULT

  • Christoffersson G, Flodstrom-Tullberg M. Mouse Models of Virus-Induced Type 1 Diabetes. Methods Mol Biol. 2020;2128:93-105. doi: 10.1007/978-1-0716-0385-7_7.

    PMID: 32180188RESULT

  • Stone VM, Hankaniemi MM, Svedin E, Sioofy-Khojine A, Oikarinen S, Hyoty H, Laitinen OH, Hytonen VP, Flodstrom-Tullberg M. A Coxsackievirus B vaccine protects against virus-induced diabetes in an experimental mouse model of type 1 diabetes. Diabetologia. 2018 Feb;61(2):476-481. doi: 10.1007/s00125-017-4492-z. Epub 2017 Nov 18.

    PMID: 29151123RESULT

  • Hyoty H, Leon F, Knip M. Developing a vaccine for type 1 diabetes by targeting coxsackievirus B. Expert Rev Vaccines. 2018 Dec;17(12):1071-1083. doi: 10.1080/14760584.2018.1548281. Epub 2018 Nov 29.

    PMID: 30449209RESULT

  • Moltchanova EV, Schreier N, Lammi N, Karvonen M. Seasonal variation of diagnosis of Type 1 diabetes mellitus in children worldwide. Diabet Med. 2009 Jul;26(7):673-8. doi: 10.1111/j.1464-5491.2009.02743.x.

    PMID: 19573115RESULT

  • Karaoglan M, Eksi F. The Coincidence of Newly Diagnosed Type 1 Diabetes Mellitus with IgM Antibody Positivity to Enteroviruses and Respiratory Tract Viruses. J Diabetes Res. 2018 Aug 16;2018:8475341. doi: 10.1155/2018/8475341. eCollection 2018.

    PMID: 30186878RESULT

  • Patterson CC, Gyurus E, Rosenbauer J, Cinek O, Neu A, Schober E, Parslow RC, Joner G, Svensson J, Castell C, Bingley PJ, Schoenle E, Jarosz-Chobot P, Urbonaite B, Rothe U, Krzisnik C, Ionescu-Tirgoviste C, Weets I, Kocova M, Stipancic G, Samardzic M, de Beaufort CE, Green A, Soltesz G, Dahlquist GG. Seasonal variation in month of diagnosis in children with type 1 diabetes registered in 23 European centers during 1989-2008: little short-term influence of sunshine hours or average temperature. Pediatr Diabetes. 2015 Dec;16(8):573-80. doi: 10.1111/pedi.12227. Epub 2014 Oct 15.

    PMID: 25316271RESULT

  • Bindom SM, Lazartigues E. The sweeter side of ACE2: physiological evidence for a role in diabetes. Mol Cell Endocrinol. 2009 Apr 29;302(2):193-202. doi: 10.1016/j.mce.2008.09.020. Epub 2008 Oct 1.

    PMID: 18948167RESULT

  • Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.

    PMID: 19333547RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for research biobank

MeSH Terms

Conditions

COVID-19Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Claus B Juhl

    Esbjerg Hospital - University Hospital of Southern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus B Juhl, MD PhD

CONTACT

+4560867172Claus.Bogh.Juhl@rsyd.dk

Morten Bjerregaard-Andersen, MD PhD

CONTACT

+4528112956Morten.Bjerregaard-Andersen2@rsyd.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., Ph.D., Clinical Professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 10, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

DK(1)