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CompletedNCT04779164Updated Mar 3, 2021

The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis

An interventional study of knee ultrasonography in Knee Osteoarthritis, sponsored by Eskisehir City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Eskisehir City Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Non-randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study 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.

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

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • knee osteoarthritis
  • type 2 diabetes
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 126 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Eskisehir City Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • being female
  • aged between 40 and 70.

Exclusion criteria

Exclusion Criteria:

  • Patients with any concomitant chronic disease
  • rheumatoid arthritis
  • cardiac diseases (except type 2 diabetes mellitus and hypertension)
  • knee surgery
  • trauma
  • bone mass or cancer
  • inflammatory arthritis
  • impaired cognitive status
  • immobilized patients
  • type 1 diabetes mellitus
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    Patients with type 2 diabetes

    Patients with diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores.

    Diagnostic Test: knee ultrasonography

  • Other
    Patients without type 2 diabetes

    Patients without diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores.

    Diagnostic Test: knee ultrasonography

Interventions

  • Diagnostic testknee ultrasonography

    The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.

06

What researchers measure

Primary outcomes

  1. Femoral cartilage thickness

    Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)

    Time frame: baseline

Secondary outcomes

  1. visual analog scale

    pain measurement (point 0 to 10) 0:worse pain 10:no pain

    Time frame: baseline

  2. radiographic knee osteoarthritis

    evaluated by kellgren lawrance scale.(0-4) 0:no osteoarthritis, 4: severe osteoarthritis

    Time frame: baseline

07

Study locations

1 site
  • Eskişehir City Hospital
    Eskişehir, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — 1 year later

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Oct 2020, 1 month.

Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 1 month is below that.

Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2021
First posted
Mar 3, 2021
StartActual
Sep 4, 2020
Primary completionActual
Oct 30, 2020
CompletionActual
Oct 30, 2020
Last update
Mar 3, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04779164
Lead sponsor
Eskisehir City Hospital
Responsible party
Fulya Bakılan (principal investigator, Eskisehir City Hospital) — Principal investigator
First posted
Mar 3, 2021
Start date
Sep 4, 2020
Primary completion
Oct 30, 2020
Completion
Oct 30, 2020
Last update
Mar 3, 2021

Study contacts

Fulya Bakılan
principal investigator · Eskisehir City Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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