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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis

• 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

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