Correlation Between Altered Glycometabolic Status and Joint Inflammation in Diabetic Patients With Osteoarthritis Undergoing Knee Arthroplasty (GLICO PG)

December 29, 2021 updated by: Istituto Ortopedico Galeazzi
Evaluate the correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee replacement surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population is made up of diabetic patients, of age, undergoing knee replacement surgery for osteoarthritis

Description

Inclusion Criteria:

  • Diabetic patients
  • Patients with osteoarthritis awaiting knee replacement surgery
  • Patients awaiting knee replacement surgery
  • Patients who agree to sign informed consent

Exclusion Criteria:

  • Patients less than 55 years of age.
  • Patients over 85 years of age.
  • Patients who are unable to understand and want.
  • Patients with severe neurological disorders or with severe disabilities.
  • Rheumatoid arthritis patients
  • Cancer patients
  • Patients suffering from chronic inflammatory bowel syndromes (RCU and Crohn's disease)
  • Patients on immunosuppressive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate if there is a linear positive correlation between plasma glycated hemoglobin concentration HbA1c and synovial IL-6 in diabetic patient
Time Frame: 2 day
To evaluate if there is a linear positive correlation between plasma glycated hemoglobin concentration HbA1c and synovial IL-6 in diabetic patient
2 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

November 27, 2021

Study Completion (Anticipated)

November 15, 2024

Study Registration Dates

First Submitted

November 27, 2021

First Submitted That Met QC Criteria

November 27, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLICO PG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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