Ultrasound of leg nerves linked to walking and balance in adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, single-center study enrolls adults 18–65 with type 2 diabetes and EMG-confirmed peripheral polyneuropathy alongside literate control participants to compare nerve imaging and function. High-resolution ultrasonography will measure lower-extremity nerve structure while standardized tests—Biodex balance system, gait assessments, DN4, numeric pain ratings, and the Toronto Clinical Neuropathy Score—quantify balance, gait, pain, and neuropathy severity. Investigators will analyze correlations between sonographic findings and functional measures to determine whether ultrasound changes track with gait impairment, balance deficits, and reduced daily activity. All imaging and performance testing are performed in person at the study hospital in Istanbul.

Why it matters

Who can join: the full rules

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

Where it's running

• Sultan 2. Abdulhamid Han Training and Research Hospital
  Istanbul, Üsküdar, Turkey (Türkiye) Recruiting
• Sultan 2. Abdulhamid Han Training and Research Hospital
  Istanbul, Üsküdar, Turkey (Türkiye) Active not recruiting

Study contacts

• Principal investigator: Semiha Özgüç, M.D. — Sultan 2. Abdulhamid Han Training and Research Hospital
• Study coordinator: Semiha Özgüç
• Email: semihaozguc@hotmail.com
• Phone: 5426311029

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.