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Completed

NCT Number: NCT04779164

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskişehir City Hospital

Eskişehir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

knee ultrasonography

Diagnostic Test

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

Primary outcomes

  1. Femoral cartilage thickness

    Time frame: baseline

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

Secondary outcomes

  1. visual analog scale

    Time frame: baseline

    pain measurement (point 0 to 10) 0:worse pain 10:no pain

  2. radiographic knee osteoarthritis

    Time frame: baseline

    evaluated by kellgren lawrance scale.(0-4) 0:no osteoarthritis, 4: severe osteoarthritis

Sponsors and collaborators

Lead sponsor

Eskisehir City Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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