The Effect of COVID-19 on Diabetes Mellitus | NCT04592055

Studies
The Effect of COVID-19 on Diabetes Mellitus

NCT04592055

Sponsor

Uşak University

Status

Unknown status

Last Update Posted

May 4, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Diabetes Mellitus
Covid19

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2020Actual

Primary Completion Date

Oct 15, 2020Actual

Completion Date

Jul 1, 2021Estimated

First Submitted Date

Oct 16, 2020

First Submission Date that Met QC Criteria

Oct 16, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2021

Last Update Posted Date

May 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aimed to evaluate the effect of SARS-COV-2 infection on metabolic status in patients with diabetes mellitus. Patients' HbA1c levels before and after SARS-COV-2 infection will be evaluated.

Detailed Description

In this time pediods, all patients with RT-PCR positive for SARS-COV-2 will be analysed for the presence of diabetes mellitus. Previous HbA1c levels will be obtained from hospital records. In these patients, previous A1c levels and A1c levels 3 months after the SARS-COV-2 infection will be compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A1c	the change in A1c levels	6 months (3 months before and after COVID-19

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All hospitalised diabetic patients with RT-PCR- positive for SARS-COV-2 will be enrolled.

Exclusion Criteria:

- The absence of diabetes mellitus RT-PCR- negative for SARS-COV-2 Non-hospitalised patients

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All hospitalised diabetic patients with RT-PCR- positive for SARS-COV-2 will be enrolled and evaluated.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cevdet Duran	Contact	02762212121		drcduran@gmail.com

Overall Officials

Name	Affiliation	Role
Cevdet Duran, Prof	Uşak University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Usak University Training and Research Hospital	Recruiting	Uşak		64200	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D000086382	COVID-19

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided