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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05096858
Other study ID # 3066
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date July 31, 2024

Study information

Verified date September 2023
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact ALFONSO GULIAS HERRERO
Phone 523123173679
Email alfonso.guliash@incmnsz.mx
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

DM2 is a major comorbidity of COVID-19. It has been observed that subjects with DM2 require more medical interventions, have a significantly higher mortality (7.8% versus 2.7%) and injuries of multiple organs that the individuals not diabetics. In situations of glycemic variability, phenomena of oxidative stress and activation of protein kinase C can be initiated , through the release of pro-inflammatory cytosines , which could induce microvascular damage .Patients with diabetes and COVID-19 were shown to be more likely to develop serious or critical illness with more complications, and to have higher incidence rates of antibiotic therapy, non-invasive and invasive mechanical ventilation, and death (11.1% vs. 4.1%).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Confirmed COVID-19 pneumonia - Diabetes mellitus Exclusion Criteria: - Less than 3 days of hospital care

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Mexico National Institute of Medical Sciences and Nutrition Salvador Zubiran Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose variability Percentage of time within the ADA recommended range For up to two weeks, during hospitalization
Primary Insulin use Average daily UI of insulin per patient For up two weeks, during hospitalization
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