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

Study Overview
=================
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

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

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Diagnostic Test: knee ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with type 2 diabetes<br>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<br>* The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.<br>|
| Other: Patients without type 2 diabetes<br>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<br>* The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral cartilage thickness | Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage) | baseline | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, knee osteoarthritis