NCT04779164

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 25, 2021

Last Update Submit

February 27, 2021

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritistype 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Femoral cartilage thickness

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

    baseline

Secondary Outcomes (2)

  • visual analog scale

    baseline

  • radiographic knee osteoarthritis

    baseline

Study Arms (2)

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.

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.

Diagnostic Test: knee ultrasonography

Interventions

knee ultrasonographyDIAGNOSTIC_TEST

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

Patients with type 2 diabetesPatients without type 2 diabetes

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsKnee osteoarthritis is more common in women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being female
  • aged between 40 and 70.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir City Hospital

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Fulya Bakılan

    Eskisehir City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 3, 2021

Study Start

September 4, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

March 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

1 year later

Locations

TU(1)