NCT05096858

Brief 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%).

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

June 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 8, 2024

Status Verified

September 1, 2023

Enrollment Period

4.1 years

First QC Date

September 13, 2021

Last Update Submit

March 7, 2024

Conditions

Diabetes MellitusCovid19

Outcome Measures

Primary Outcomes (2)

  • Glucose variability

    Percentage of time within the ADA recommended range

    For up to two weeks, during hospitalization

  • Insulin use

    Average daily UI of insulin per patient

    For up two weeks, during hospitalization

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults living with diabetes and suffering from COVID19 pneumonia

You may qualify if:

  • Confirmed COVID-19 pneumonia
  • Diabetes mellitus

You may not qualify if:

  • Less than 3 days of hospital care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Medical Sciences and Nutrition Salvador Zubiran

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusCOVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • ALFONSO GULIAS HERRERO

    INCMNSZ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ALFONSO GULIAS HERRERO

CONTACT

523123173679alfonso.guliash@incmnsz.mx

ALHELY GAYTAN SANTILLAN

CONTACT

alhely.gaytans@incmnsz.mx

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 27, 2021

Study Start

June 1, 2020

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

March 8, 2024

Record last verified: 2023-09

Locations

ME(1)