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

NCT ID: NCT04779164

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2020-10-30

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patients with type 2 diabetes

Patients with diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores.

Group Type EXPERIMENTAL

knee ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Patients without type 2 diabetes

Patients without diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores.

Group Type OTHER

knee ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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knee ultrasonography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fulya Bakılan

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fulya Bakılan

Role: PRINCIPAL_INVESTIGATOR

Eskisehir City Hospital

Locations

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Eskişehir City Hospital

Eskişehir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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EskCityHosp

Identifier Type: -

Identifier Source: org_study_id

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