Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy

Not Applicable

Recruiting

• Conditions: Peripheral Neuropathy; Type 2 Diabetes Mellitus
• Interventions: Procedure: Acetylcholine Iontophoresis; Procedure: Shame Acetylcholine Iontophoresis

• Registration Number: NCT06219590
• Lead Sponsor: South Valley University

Brief Summary

The investigators initial study opened the way for randomized trials that monitor the effects of acetylcholine (Ach) iontophoresis vasodilators on endothelial nitric oxide synthetase (NOS) to develop a transdermal treatment that is effective, free from systemic adverse effects.

Detailed Description

The investigators studied endothelial-mediated microvascular blood flow in neuropathic diabetic patients to determine the association between endothelial regulation of the microcirculation and the expression of endothelial constitutive nitric oxide synthetase (NOS). As a result, the nerve fibers can become damaged. Once the nerves have been damaged they cannot repair themselves.

Material and methods:

A group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study their age ranged from 40-60 years. Patients randomly will be divided into two groups:

Study groups (A) 40 patients type 2 diabetes mellitus with clinically proved peripheral neuropathy. And control group (B) 40 patients with asymptomatic type 2 diabetes mellitus. They were selected from south valley university hospitals. Group (A) receive iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks. Also the investigators followed up study group (A) one month of aerobic exercises in form of 15 minute walking, bicycling, or swimming, and the investigators reevaluated nitric oxide level. Group (B) received shame iontophoresis with (15) min for three sessions per week for four weeks.

Study Timeline

• Study First Submitted: 2023-10-27
• Study Start: 2023-10-28
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Primary Completion: 2024-01-20
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
• Optimized pharmacological treatment that will be remained unchanged throughout the study.

Exclusion Criteria

• Implanted cardiac pacemakers.
• Patients with known skin allergies.
• Presence of skin inflammations.
• Peripheral vascular disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group (A)	Acetylcholine Iontophoresis	* 40 patients with type 2 diabetes mellitus clinically proved peripheral neuropathy. * Both groups were received conventional medical treatment and healthy diet. * Group A was received iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks.
Control group (B)	Shame Acetylcholine Iontophoresis	* 40 patients with asymptomatic type 2 diabetes mellitus, both groups were selected from south valley university hospitals. * Both groups were received conventional medical treatment and healthy diet. * Group (B) was received shame iontophoresis with (15) min for three sessions per week for four weeks.

Primary Outcome Measures

Name	Time	Method
Electrophysiological assessment of patients with acetylcholine iontophoresis and Ach iontophoresis role in improving diabetic peripheral neuropathy	one month (baseline assessment and after one month of Ach iontophoresis and exercise)	Nerve conduction velocity of nerves and needle EMG of upper limb and lower limbs will be assessed pre and post exposure, expecting improvement in nerve conduction velocity (expressed latency ms, amplitude mv).
Numerical rating pain scale	One month	Patient just say the level of pain feeling, zero means no pain, while 10 means most intense pain possible. Expecting pain improvement after one month of Ach iontophoresis and exercise
Role of acetylcholine iontophoresis in improving Nitric oxide level in diabetic peripheral neuropathy patients.	one month (baseline assessment and after one month of Ach iontophoresis and exercise)	Blood samples were withdrawn from visible peripheral veins by venipuncture then centrifuged and serum was used for nitric oxide level assessment (No micromole/liter) , Nitric oxide measured using commercially available calorimetric assay kits using spectrophotometer (chem7 erba, labomed, Germany). Suspected improvement in nitric oxide level by acetylcholine iontophoresis, patient will receive three sessions iontophoresis weekly for one month and No will be assessed baseline and post assay will be done pre (baseline) and post acetylcholine iontophoresis exposure and aerobic exercise.

Trial Locations

Locations (1)

Faculty of Physical Therapy, South Valley University; 🇪🇬 Qinā, Egypt