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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
knee ultrasonography
Sponsored by
Eskisehir City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, type 2 diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Eskişehir City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patients with type 2 diabetes

Patients without type 2 diabetes

Arm Description

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

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

Outcomes

Primary Outcome Measures

Femoral cartilage thickness
Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2021
Last Updated
February 27, 2021
Sponsor
Eskisehir City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04779164
Brief Title
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
Official Title
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, type 2 diabetes

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with type 2 diabetes
Arm Type
Experimental
Arm Description
Patients with diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores.
Arm Title
Patients without type 2 diabetes
Arm Type
Other
Arm Description
Patients without diabetes mellitus was evaluated in terms of pain scores and ultrasonographic femoral cartilage thickness and retrospective radiographic knee osteoarthritis scores.
Intervention Type
Diagnostic Test
Intervention Name(s)
knee ultrasonography
Intervention Description
The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.
Primary Outcome Measure Information:
Title
Femoral cartilage thickness
Description
Measured by ultrasonography (higher value:thick cartilage, lower value:thin cartilage)
Time Frame
baseline
Secondary Outcome Measure Information:
Title
visual analog scale
Description
pain measurement (point 0 to 10) 0:worse pain 10:no pain
Time Frame
baseline
Title
radiographic knee osteoarthritis
Description
evaluated by kellgren lawrance scale.(0-4) 0:no osteoarthritis, 4: severe osteoarthritis
Time Frame
baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Knee osteoarthritis is more common in women.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulya Bakılan
Organizational Affiliation
Eskisehir City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskişehir City Hospital
City
Eskişehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
1 year later

Learn more about this trial

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

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