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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Diagnostic Test: knee ultrasonography

• Registration Number: NCT04779164
• Lead Sponsor: Eskisehir City Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-04
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-27
• Last Update Submitted: 2021-02-27
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• being female
• aged between 40 and 70.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with type 2 diabetes	knee ultrasonography	Patients 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	knee ultrasonography	Patients without diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores.

Primary Outcome Measures

Name	Time	Method
Femoral cartilage thickness	baseline	Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)

Secondary Outcome Measures

Name	Time	Method
visual analog scale	baseline	pain measurement (point 0 to 10) 0:worse pain 10:no pain
radiographic knee osteoarthritis	baseline	evaluated by kellgren lawrance scale.(0-4) 0:no osteoarthritis, 4: severe osteoarthritis

Trial Locations

Locations (1)

Eskişehir City Hospital; 🇹🇷 Eskişehir, Turkey