Clinical trial NCT06778005: Investigation of Ultrasonographic Measurements of Lower Extremity Nerves in Type 2 Diabetes Patients With Peripheral Polyneuropathy
Official title: Investigation of the Relationship of Ultrasonographic Measurements of Lower Extremity Nerves With Gait and Balance Performance in Type 2 Diabetes Patients With Peripheral Polyneuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Diabetic Polyneuropathy
Keywords: polyneuropathy
Ultrasound
diabetes
balance
gait
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetic polyneuropathy and healthy volunteers aged between 18-65 years old will be evaluated visiting our physical medicine and rehabilitation outpatient clinic between December 2024 and May 2025.

Brief summary: The aim of this study is to quantitatively evaluate ultrasonographic measurements of the lower extremity nerves in patients diagnosed with diabetic polyneuropathy and to investigate the relationship with gait, static and dynamic balance performance.

In this study, we aimed to investigate the effect of ultrasonographic findings of lower extremity nerves on quality of daily life, physical activity, gait and balance in patients with diabetic peripheral polyneuropathy.

Detailed description: Diabetes is a chronic metabolic disorder characterized by hyperglycemia and the body's inability to adequately utilize carbohydrates, fats, and proteins due to a reduction in insulin secretion or insulin action. It requires continuous medical care.

One of the most common complications associated with diabetes is diabetic neuropathy, which affects the autonomic, motor, and sensory nerves of the peripheral nervous system. The most frequent form of diabetic neuropathy is peripheral sensorimotor polyneuropathy. Clinical and electrophysiological findings typically begin in the distal lower extremities.

While nerve conduction studies remain the gold standard for diagnosing diabetic neuropathy, they are time-consuming, require a separate patient visit, and are too costly to recommend for routine screening. Various methods can be employed to assess the morphological changes in nerves associated with diabetic peripheral neuropathy. With advancing technology in recent years, ultrasonography (US) has emerged as an affordable, reproducible, and more comfortable technique. It can be utilized as an effective method to evaluate structural changes in nerves. Diabetic neuropathy is a significant contributor to the severe morbidity, increased mortality, and reduced quality of life in diabetic patients. Therefore, the early detection of nerve dysfunction through ultrasonography is essential for providing appropriate care to patients with diabetic neuropathy.

The study will be conducted as a cross-sectional and single-center research involving patients with peripheral polyneuropathy secondary to type 2 diabetes and healthy volunteers who present to the Physical Medicine and Rehabilitation Clinic at the Health Sciences University Sultan 2nd Abdülhamid Han Training and Research Hospital.

As part of the study, demographic data collected from participants will include age, gender, height, weight, body mass index, smoking and alcohol usage, marital status, occupation, educational level, fasting blood glucose, HbA1c levels, vitamin B12, ALT, AST, creatinine levels, duration of diabetes, duration of diabetic peripheral polyneuropathy (DPP) complaints, current antidiabetic medications, presence of comorbidities, and neuropathic pain treatment and duration. Patients will be evaluated once, and the assessment will include ultrasonography, the Biodex balance system, the Douleur Neuropathique 4 (DN4) pain scale, numeric pain scale, Toronto Clinical Neuropathy Score, diapason vibration sensitivity test, 6-minute walk test, SF-12 quality of life scale, International Physical Activity Questionnaire-Short Form, Timed Up and Go Test (TUG), and motor and sensory examination.

The sample size for the study was calculated using G-Power version 3.1, based on ultrasonographic measurement data from a similar study conducted by Breiner et al. in 2016. The calculated sample size includes Group 1: 17 healthy participants of similar age and gender, and Group 2: 69 participants diagnosed with peripheral polyneuropathy and type 2 diabetes, amounting to a total of 86 participants. The study is planned to be conducted between December 2024 and May 2025.

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

Primary outcomes:
measure: Ultrasonography
timeFrame: 6 months
Secondary outcomes:
measure: Biodex Balance System
timeFrame: 6 months
measure: Douleur Neuropathique 4 (DN4) Pain Scale
timeFrame: 6 months
measure: Numeric Rating Scale
timeFrame: 6 months
measure: Toronto Clinical Neuropathy Score
timeFrame: 6 months
measure: Six-Minute Walk Test
timeFrame: 6 months
measure: SF-12 Quality of Life Scale
timeFrame: 6 months
measure: International Physical Activity Questionnaire-Short Form (IPAQ)
timeFrame: 6 months
measure: Tuning Fork Vibration Sense
timeFrame: 6 months
measure: Timed Up and Go Test
timeFrame: 6 months
measure: Physical Examination
timeFrame: 6 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sultan 2. Abdulhamid Han Training and Research Hospital
state: Üsküdar
city: Istanbul
country: Turkey
facility: Sultan 2. Abdulhamid Han Training and Research Hospital
state: Üsküdar
Study officials:
affiliation: Sultan 2. Abdulhamid Han Training and Research Hospital
name: Emre Ata, Ass. Prof.
role: STUDY_DIRECTOR
affiliation: Sultan 2. Abdulhamid Han Training and Research Hospital
name: Feyza Nur Yücel, Specialist
role: STUDY_DIRECTOR
affiliation: Sultan 2. Abdulhamid Han Training and Research Hospital
name: Semiha Özgüç, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bril V, Tomioka S, Buchanan RA, Perkins BA; mTCNS Study Group. Reliability and validity of the modified Toronto Clinical Neuropathy Score in diabetic sensorimotor polyneuropathy. Diabet Med. 2009 Mar;26(3):240-6. doi: 10.1111/j.1464-5491.2009.02667.x.
citation: Arnold BL, Schmitz RJ. Examination of balance measures produced by the biodex stability system. J Athl Train. 1998 Oct;33(4):323-7.
citation: Arumugam T, Razali SN, Vethakkan SR, Rozalli FI, Shahrizaila N. Relationship between ultrasonographic nerve morphology and severity of diabetic sensorimotor polyneuropathy. Eur J Neurol. 2016 Feb;23(2):354-60. doi: 10.1111/ene.12836. Epub 2015 Oct 25.
citation: Fisse AL, Katsanos AH, Gold R, Krogias C, Pitarokoili K. Cross-sectional area reference values for peripheral nerve ultrasound in adults: A systematic review and meta-analysis-Part II: Lower extremity nerves. Eur J Neurol. 2021 Jul;28(7):2313-2318. doi: 10.1111/ene.14850. Epub 2021 May 7.
citation: Sundaram TK. Myo-inositol catabolism in Salmonella typhimiurium: enzyme repression dependent on growth history of organism. J Gen Microbiol. 1972 Nov;73(2):209-19. doi: 10.1099/00221287-73-2-209. No abstract available.
citation: Breiner A, Qrimli M, Ebadi H, Alabdali M, Lovblom LE, Abraham A, Albulahi H, Perkins BA, Bril V. Peripheral nerve high-resolution ultrasound in diabetes. Muscle Nerve. 2017 Feb;55(2):171-178. doi: 10.1002/mus.25223. Epub 2016 Nov 10.
citation: Harreiter J, Roden M. [Diabetes mellitus: definition, classification, diagnosis, screening and prevention (Update 2023)]. Wien Klin Wochenschr. 2023 Jan;135(Suppl 1):7-17. doi: 10.1007/s00508-022-02122-y. Epub 2023 Apr 20. German.