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Covid-19 Infection and New Onset Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04623697
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Steno Diabetes Center Odense
Steno Diabetes Center Nordjylland
Steno Diabetes Center Aarhus
Steno Diabetes Center Sjaelland
Steno Diabetes Center Copenhagen
Information provided by (Responsible Party):
Claus Bogh Juhl, Hospital of South West Jutland

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.


Condition or disease
Covid19 type1diabetes

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Covid-19 and Type 1 Diabetes - a Multicenter Study
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Stimulated insulin secretion [ Time Frame: One years ]
    C-peptide AUC of the MMTT at baseline and one year follow-up


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: One years ]
    HbA1c measure at one year

  2. Fasting blood glucose [ Time Frame: One years ]
    Fasting blood glucose


Biospecimen Retention:   Samples Without DNA
Blood for research biobank


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All newly diagnosed people with type 1 diabetes
Criteria

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 patient's informed consent and participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623697


Contacts
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Contact: Claus B Juhl, MD PhD +4560867172 Claus.Bogh.Juhl@rsyd.dk
Contact: Morten Bjerregaard-Andersen, MD PhD +4528112956 Morten.Bjerregaard-Andersen2@rsyd.dk

Locations
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Denmark
Hospital of South West Jutland Recruiting
Esbjerg, Denmark, 6700
Contact: Claus B Juhl, MD, PhD    +4560867172    claus.bogh.juhl@rsyd.dk   
Contact: Morten Bjerregaard-Andersen, MSc, PhD    +4528112956    Morten.Bjerregaard-Andersen2@rsyd.dk   
Sponsors and Collaborators
Hospital of South West Jutland
Steno Diabetes Center Odense
Steno Diabetes Center Nordjylland
Steno Diabetes Center Aarhus
Steno Diabetes Center Sjaelland
Steno Diabetes Center Copenhagen
Investigators
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Principal Investigator: Claus B Juhl Hospital of South West Jutland
Publications of Results:

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Responsible Party: Claus Bogh Juhl, MD., Ph.D., Clinical Professor, Hospital of South West Jutland
ClinicalTrials.gov Identifier: NCT04623697    
Other Study ID Numbers: S-20200119
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claus Bogh Juhl, Hospital of South West Jutland:
Covid19
Type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases