Knee OsteoarthritisNCT04779164
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
A study testing knee ultrasonography in people with Knee Osteoarthritis, run by Eskisehir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background:Knee osteoarthritis is more common in patients with type-2 diabetes mellitus, however it is not known whether this effect is caused by diabetes itself or concominant abdominal obesity. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- knee ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2020to 30 Oct 2020
- Phase
- Interventional
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being female
- aged between 40 and 70.
Who cannot join
- Patients with any concomitant chronic disease
- rheumatoid arthritis
- cardiac diseases (except type 2 diabetes mellitus and hypertension)
- knee surgery
- trauma
- bone mass or cancer
Show all 10Show fewer
- inflammatory arthritis
- impaired cognitive status
- immobilized patients
- type 1 diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Background:Knee osteoarthritis is more common in patients with type-2 diabetes mellitus, however it is not known whether this effect is caused by diabetes itself or concominant abdominal obesity.
Objectives:The aim of this study is to determine whether type-2 diabetes itself, independent of abdominal obesity, is a risk factor for femoral cartilage, knee osteoarthritis and poor quality of life.
Read more
Design:A cross-sectional design. Settings:Training and research hospital in Turkey. Patients and Methods:Female patients was enrolled in this study and divided into two groups: according to presence or absence of diabetes. Later, both the patients with and without abdominal obesity was divided into two groups according the presence of diabetes.
Main Outcome measures:Clinical parameters were visual analog-scale, gait speed and short form-36. Knee radiographs were evaluated according to Kellgren Lawrance-Scale. And ultrasonography parameters were the measurements of distal femoral cartilage thickness.
Sample size:126
- Conditions
- Knee Osteoarthritis
- Being tested
- knee ultrasonography
- Keywords
- knee osteoarthritis, type 2 diabetes
- Medical subject headings
- Osteoarthritis, Knee, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee ultrasonographyDiagnostic test
The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Experimental | Patients with diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores. Receives: Diagnostic Test: knee ultrasonography |
| Patients without type 2 diabetes | Other | Patients without diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores. Receives: Diagnostic Test: knee ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral cartilage thickness
Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)
Measured: baseline
Secondary outcomes (2)
visual analog scale
pain measurement (point 0 to 10) 0:worse pain 10:no pain
Measured: baseline
radiographic knee osteoarthritis
evaluated by kellgren lawrance scale.(0-4) 0:no osteoarthritis, 4: severe 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 posted3 Mar 2021
- Study start4 Sep 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Bakılan, Eskisehir City Hospital
- Investigators
- Fulya Bakılan, Principal investigator, Eskisehir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779164
- Sponsor's protocol ID
- EskCityHosp
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1 year later
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04779164
- Acronym / sponsor ID
- EskCityHosp
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Eskisehir City HospitalUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 3 Mar 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.
Background:Knee osteoarthritis is more common in patients with type-2 diabetes mellitus, however it is not known whether this effect is caused by diabetes itself or concominant abdominal obesity.
Objectives:The aim of this study is to determine whether type-2 diabetes itself, independent of abdominal obesity, is a risk factor for femoral cartilage, knee osteoarthritis and poor quality of life.
Design:A cross-sectional design. Settings:Training and research hospital in Turkey. Patients and Methods:Female patients was enrolled in this study and divided into two groups: according to presence or absence of diabetes. Later, both the patients with and without abdominal obesity was divided into two groups according the presence of diabetes.
Main Outcome measures:Clinical parameters were visual analog-scale, gait speed and short form-36. Knee radiographs were evaluated according to Kellgren Lawrance-Scale. And ultrasonography parameters were the measurements of distal femoral cartilage thickness.
Sample size:126
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | Experimental | Diagnostic Test: knee ultrasonographyPatients with diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores. |
| Patients without type 2 diabetes | Other | Diagnostic Test: knee ultrasonographyPatients without diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being female
- aged between 40 and 70.
Key exclusion criteria (10 listed)
- Patients with any concomitant chronic disease
- rheumatoid arthritis
- cardiac diseases (except type 2 diabetes mellitus and hypertension)
- knee surgery
- trauma
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 |
|---|---|---|
| knee ultrasonographyThe knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses. | Diagnostic test | Patients with type 2 diabetes, Patients without type 2 diabetes |
Primary outcome
Femoral cartilage thickness
Time frame: baseline
Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)
2 secondary outcomes
visual analog scale
Time frame: baseline
radiographic knee osteoarthritis
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No. 1 year later
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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. This study is not recruiting at the moment.
Fulya Bakılan principal investigator
Eskisehir City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knee ultrasonography in people with Knee Osteoarthritis, run by Eskisehir City Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 3 Mar 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral cartilage thickness (time frame: baseline). 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 3 Mar 2021.