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Clinical Trials/DRKS00024879
DRKS00024879
Recruiting
Not Applicable

Immune response and therapy assessment to COVID-19 Vaccinations in people with Diabetes Mellitus – an observational pilot study - COVACDIA

Division Exercise Physiology and Metabolism0 sites60 target enrollmentJune 2, 2021
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ConditionsE10E11Type 1 diabetes mellitusType 2 diabetes mellitus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
E10
Sponsor
Division Exercise Physiology and Metabolism
Enrollment
60
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2021
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Division Exercise Physiology and Metabolism

Eligibility Criteria

Inclusion Criteria

  • •Planned COVID\-19 vaccination(Each participant)
  • •Cohort I (Diabetes mellitus Type 1, well controlled)
  • •Glycated haemoglobin levels HbA1c \=7\.5 %
  • •Cohort II (Diabetes mellitus Type 1, uncontrolled)
  • •Glycated haemoglobin levels HbA1c \>7\.5 %
  • •Cohort III (Diabetes mellitus Type 2, well controlled)
  • •Glycated haemoglobin levels HbA1c \=7\.5 %
  • •Cohort IV (Diabetes mellitus Type 2, uncontrolled)
  • •Glycated haemoglobin levels HbA1c \>7\.5 %

Exclusion Criteria

  • •Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
  • •Pregnancy or intention of becoming pregnant; breastfeeding
  • •Immunosuppressive therapy
  • •Acute inflammatory disorder
  • •Alcohol abuse (more than 15 drinks / week)
  • •Any contraindication to the vaccine planned to receive as listed in the product characteristics
  • •Previous COVID\-19 vaccine or episode of COVID\-19
  • •/ Healthy control group:
  • •Presence of disease or therapies that are likely to interfere with the immune response to vaccination
  • •Presence of a disease requiring change in therapy during 4 weeks prior to enrollment

Outcomes

Primary Outcomes

Not specified

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