To Evaluate a Linear Positive Correlation Between Plasma HbA1c and Synovial IL-6 in Diabetic PatientsGLICO PGNCT05150119
Correlation Between Altered Glycometabolic Status and Joint Inflammation in Diabetic Patients With Osteoarthritis Undergoing Knee Arthroplasty
An observational study of To Evaluate a Linear Positive Correlation Between Plasma HbA1c and Synovial IL-6 in Diabetic Patients, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Evaluate the correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee replacement surgery Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- To Evaluate a Linear Positive Correlation Between Plasma HbA1c and Synovial IL-6 in Diabetic Patients
- What is being tested?
- Evaluation of Synovial IL-6 in diabetic patients with gonarthrosis
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2021to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population is made up of diabetic patients, of age, undergoing knee replacement surgery for osteoarthritis
Who may be able to join
- Diabetic patients
- Patients with osteoarthritis awaiting knee replacement surgery
- Patients awaiting knee replacement surgery
- Patients who agree to sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Cesare Donarini, 0248785220, cesare.donarini@grupposandonato.it
About this study
Evaluate the correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee replacement surgery
- Being tested
- Evaluation of Synovial IL-6 in diabetic patients with gonarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Synovial IL-6 in diabetic patients with gonarthrosisDiagnostic test
Also called Evaluation of plasmatic HbA1c in diabetic patients with gonarthrosis
To evaluate if there is a linear positive correlation between plasma glycated hemoglobin concentration HbA1c and synovial IL-6 in diabetic patients
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate if there is a linear positive correlation between plasma glycated hemoglobin concentration HbA1c and synovial IL-6 in diabetic patient
To evaluate if there is a linear positive correlation between plasma glycated hemoglobin concentration HbA1c and synovial IL-6 in diabetic patient
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Nov 2021
- Primary completion27 Nov 2021
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate a Linear Positive Correlation Between Plasma HbA1c and Synovial IL-6 in Diabetic PatientsStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150119
- Sponsor's protocol ID
- GLICO PG
- Acronym
- GLICO PG
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Altered Glycometabolic Status and Joint Inflammation in Diabetic Patients With Osteoarthritis Undergoing Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05150119
- Acronym / sponsor ID
- GLICO PG / GLICO PG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee replacement surgery
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is made up of diabetic patients, of age, undergoing knee replacement surgery for osteoarthritis
Key inclusion criteria (4 listed)
- Diabetic patients
- Patients with osteoarthritis awaiting knee replacement surgery
- Patients awaiting knee replacement surgery
- Patients who agree to sign informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of Synovial IL-6 in diabetic patients with gonarthrosisAlso: Evaluation of plasmatic HbA1c in diabetic patients with gonarthrosisTo evaluate if there is a linear positive correlation between plasma glycated hemoglobin concentration HbA1c and synovial IL-6 in diabetic patients | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate a Linear Positive Correlation Between Plasma HbA1c and Synovial IL-6 in Diabetic Patients, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cesare Donarini (0248785220, cesare.donarini@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.