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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779164
• Other study ID #: EskCityHosp
• Status: Completed
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: Eskisehir City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Knee Osteoarthritis
• Obesity, Abdominal
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Diagnostic Test:
• knee ultrasonography
The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.

Locations

Country	Name	City	State
Turkey	Eskisehir City Hospital	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral cartilage thickness	Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)	baseline
Secondary	visual analog scale	pain measurement (point 0 to 10) 0:worse pain 10:no pain	baseline
Secondary	radiographic knee osteoarthritis	evaluated by kellgren lawrance scale.(0-4) 0:no osteoarthritis, 4: severe osteoarthritis	baseline