Investigation of Ultrasonographic Measurements of Lower Extremity Nerves in Type 2 Diabetes Patients With Peripheral Polyneuropathy

Launched by SULTAN ABDULHAMID HAN TRAINING AND RESEARCH HOSPITAL, ISTANBUL, TURKEY · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how ultrasound images of the nerves in the legs can help us understand the effects of diabetic peripheral polyneuropathy in people with Type 2 diabetes. The researchers want to see how these nerve measurements relate to everyday activities like walking and maintaining balance. By studying this, they hope to find ways to improve the quality of life and physical activity for patients dealing with this condition.

To participate in the study, individuals need to be between 18 to 65 years old and should have a diagnosis of Type 2 diabetes along with diabetic peripheral polyneuropathy, which is confirmed through a specific test. Participants must also be able to read and sign a consent form agreeing to join the study. The trial is not yet recruiting participants, so there will be no immediate action required. If you or someone you know is interested, it’s essential to consider the eligibility criteria and consult with a healthcare provider for more information.

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Eligibility criteria

• Inclusion Criteria (Group 1):
• • Being between the ages of 18-65
• • Being literate
• • Signed a voluntary consent form agreeing to participate in the study
• Inclusion Criteria (Group 2):
• • Diagnosed with Type 2 Diabetes based on at least one of the following diagnostic criteria: fasting plasma glucose ≥ 126 mg/dl, 2-hour plasma glucose ≥ 200 mg/dl in an oral glucose tolerance test, HbA1c ≥ 6.5%, or diabetes symptoms (excessive thirst, eating, urination, and weight loss) + random plasma glucose ≥ 200 mg/dl. (14)
• • Diagnosed with diabetic peripheral polyneuropathy through EMG evaluation in addition to Type 2 Diabetes.
• • Being between the ages of 18-65
• • Being literate
• • Signed a voluntary consent form agreeing to participate in the study.
• Exclusion Criteria:
• • Individuals under 18 years old and over 65 years old
• • Diagnosed with Type 1 diabetes
• • Use of medications that can cause polyneuropathy
• • Other causes of neuropathic pain (lumbar radiculopathy, spinal stenosis, -hereditary, inflammatory, entrapment neuropathies)
• • Undergoing lower extremity surgery (spine/hip/knee/foot) in the last 6 months
• • Having peripheral artery disease
• • B12 vitamin deficiency
• • Active foot ulcer
• • History of lower extremity amputation
• • Severe cardiopulmonary insufficiency (stage 3-4)
• • History of myocardial infarction within the last 1 month
• • History of unstable angina
• • Active systemic inflammatory diseases and active malignancy
• • Presence of vestibular disorders
• • Presence of cognitive impairment
• • Osteoarthritis in the lower extremity
• • Pregnancy
• • Body Mass Index (BMI) of 30 or higher