Knee OsteoarthritisNCT06611774
Metabolic Syndrome in Patients with Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Metabolic Syndrome, run by Assiut University.
Trial summary
Study the prevalence of metabolic syndrome in patients with knee osteoarthritis and conclude the relationship between metabolic syndrome and the severity of knee osteoarthritis Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Metabolic Syndrome
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in assiut university hospitals and presenting to its clinics
Who may be able to join
- Both males and female .
- Age between 30 and 70 years old.
- Patient fulfill the criteria of knee osteoarthritis .
Who cannot join
- Patients known to have rheumatological disease .
- Patients with meniscal or cruciate ligament injury .
- Patients with previous knee surgery .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Study the prevalence of metabolic syndrome in patients with knee osteoarthritis and conclude the relationship between metabolic syndrome and the severity of knee osteoarthritis
Read the detailed description
Osteoarthritis is one of the most common clinical conditions causing severe chronic and restrictive disability, especially in elderly people.
Of those aged 60 years and older, 10% of men and 13% of women had symptomatic knee OA . As the population ages and the prevalence of obesity and overweight generaly rises , the percentage of persons affected with symptomatic knee OA will likely increase.
The clinical manifestations in patients are joint pain, stiffness, and functional limitation .
Among all body joints; knee joint is the most commonly affected joint with osteoarthritis and accounts almost for four-fifth of the osteoarthritis burden worldwide .
Epidemiological research has shown an encouraging relationship between OA and metabolic syndrome , MetS include hypertension, dyslipidemia, hyperglycemia, and obesity .Recently, metabolic OA has been nominated as the fifth component of MetS .
Studies reported that adipokines may contribute to the development of osteoarthritis (OA) by increasing inflammatory cytokines and growth factors, modifying insulin sensitivity, and triggering processes that break down cartilage.
Studies also reported that hypertension can be linked to osteoarthritis through astherosclerosis which cause subchondral bone ischemia accelerating OA progression.
Furthermore, researches have linked glucose levels to knee osteoarthritis , supporting the possibility of pathophysiological mechanisms such oxidative stress in the chondrocytes and Cartilage-associated production of advanced glycation end products (AGEs) .
- Conditions
- Knee Osteoarthritis, Metabolic Syndrome
- Keywords
- knee osteoarthritis, metabolic syndrome
- Medical subject headings
- Osteoarthritis, Knee, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome in patients with knee osteoarthritis
Study the prevalence of metabolic syndrome in patients with knee osteoarthritis and the relation between metabolic syndrome and clinical, functional, radiological finding of knee osteoarthritis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cross-sectional
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady kerollos louis shamroukh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611774
- Sponsor's protocol ID
- osteoarthritis MetSyndrome
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maddah S, Mahdizadeh J. Association of Metabolic Syndrome and Its Components with Knee Osteoarthritis. Acta Med Iran. 2015 Dec;53(12):743-8.
PubMed 26749230Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
PubMed 20699159Goldring SR, Goldring MB. Changes in the osteochondral unit during osteoarthritis: structure, function and cartilage-bone crosstalk. Nat Rev Rheumatol. 2016 Nov;12(11):632-644. doi: 10.1038/nrrheum.2016.148. Epub 2016 Sep 22.
PubMed 27652499Xie DX, Wei J, Zeng C, Yang T, Li H, Wang YL, Long HZ, Wu ZY, Qian YX, Li KH, Lei GH. Association between metabolic syndrome and knee osteoarthritis: a cross-sectional study. BMC Musculoskelet Disord. 2017 Dec 16;18(1):533. doi: 10.1186/s12891-017-1890-9.
PubMed 29246142Courties A, Sellam J. Osteoarthritis and type 2 diabetes mellitus: What are the links? Diabetes Res Clin Pract. 2016 Dec;122:198-206. doi: 10.1016/j.diabres.2016.10.021. Epub 2016 Nov 5.
PubMed 27889689Tu C, He J, Wu B, Wang W, Li Z. An extensive review regarding the adipokines in the pathogenesis and progression of osteoarthritis. Cytokine. 2019 Jan;113:1-12. doi: 10.1016/j.cyto.2018.06.019. Epub 2018 Jun 28.
PubMed 30539776
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome in Patients with Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06611774
- Acronym / sponsor ID
- osteoarthritis MetSyndrome
- Conditions
- Knee Osteoarthritis, Metabolic Syndrome
- Keywords
- knee osteoarthritis, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Sep 2024 (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.
Study the prevalence of metabolic syndrome in patients with knee osteoarthritis and conclude the relationship between metabolic syndrome and the severity of knee osteoarthritis
Detailed description
Osteoarthritis is one of the most common clinical conditions causing severe chronic and restrictive disability, especially in elderly people.
Of those aged 60 years and older, 10% of men and 13% of women had symptomatic knee OA . As the population ages and the prevalence of obesity and overweight generaly rises , the percentage of persons affected with symptomatic knee OA will likely increase.
The clinical manifestations in patients are joint pain, stiffness, and functional limitation .
Among all body joints; knee joint is the most commonly affected joint with osteoarthritis and accounts almost for four-fifth of the osteoarthritis burden worldwide .
Epidemiological research has shown an encouraging relationship between OA and metabolic syndrome , MetS include hypertension, dyslipidemia, hyperglycemia, and obesity .Recently, metabolic OA has been nominated as the fifth component of MetS .
Studies reported that adipokines may contribute to the development of osteoarthritis (OA) by increasing inflammatory cytokines and growth factors, modifying insulin sensitivity, and triggering processes that break down cartilage.
Studies also reported that hypertension can be linked to osteoarthritis through astherosclerosis which cause subchondral bone ischemia accelerating OA progression.
Furthermore, researches have linked glucose levels to knee osteoarthritis , supporting the possibility of pathophysiological mechanisms such oxidative stress in the chondrocytes and Cartilage-associated production of advanced glycation end products (AGEs) .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in assiut university hospitals and presenting to its clinics
Key inclusion criteria (3 listed)
- Both males and female .
- Age between 30 and 70 years old.
- Patient fulfill the criteria of knee osteoarthritis .
Key exclusion criteria (3 listed)
- Patients known to have rheumatological disease .
- Patients with meniscal or cruciate ligament injury .
- Patients with previous knee surgery .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic syndrome in patients with knee osteoarthritis
Time frame: Baseline
Study the prevalence of metabolic syndrome in patients with knee osteoarthritis and the relation between metabolic syndrome and clinical, functional, radiological finding of knee osteoarthritis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 26749230Maddah S, Mahdizadeh J. Association of Metabolic Syndrome and Its Components with Knee Osteoarthritis. Acta Med Iran. 2015 Dec;53(12):743-8.
- Background: PubMed 20699159Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
- Background: PubMed 27652499Goldring SR, Goldring MB. Changes in the osteochondral unit during osteoarthritis: structure, function and cartilage-bone crosstalk. Nat Rev Rheumatol. 2016 Nov;12(11):632-644. doi: 10.1038/nrrheum.2016.148. Epub 2016 Sep 22.
- Background: PubMed 29246142Xie DX, Wei J, Zeng C, Yang T, Li H, Wang YL, Long HZ, Wu ZY, Qian YX, Li KH, Lei GH. Association between metabolic syndrome and knee osteoarthritis: a cross-sectional study. BMC Musculoskelet Disord. 2017 Dec 16;18(1):533. doi: 10.1186/s12891-017-1890-9.
- Background: PubMed 27889689Courties A, Sellam J. Osteoarthritis and type 2 diabetes mellitus: What are the links? Diabetes Res Clin Pract. 2016 Dec;122:198-206. doi: 10.1016/j.diabres.2016.10.021. Epub 2016 Nov 5.
- Background: PubMed 30539776Tu C, He J, Wu B, Wang W, Li Z. An extensive review regarding the adipokines in the pathogenesis and progression of osteoarthritis. Cytokine. 2019 Jan;113:1-12. doi: 10.1016/j.cyto.2018.06.019. Epub 2018 Jun 28.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Metabolic Syndrome, run by Assiut University.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fady Kerollos Louis, Dr (01207936730, Fadykeros5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome in patients with knee osteoarthritis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611774, which also lists 6 linked publications.
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 25 Sep 2024.