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

January 12, 2024 updated by: Reham Abdelrazek Mohamed Ellisy, South Valley University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group (A)
  • 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.
Procedure: Acetylcholine Iontophoresis
Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.
Sham Comparator: Control group (B)
  • 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.
Procedure: Shame Acetylcholine Iontophoresis
Shame Acetylcholine Iontophoresis 15 min/ three sessions/ week for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of acetylcholine iontophoresis in improving Nitric oxide level in diabetic peripheral neuropathy patients.
Time Frame: 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.
one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Electrophysiological assessment of patients with acetylcholine iontophoresis and Ach iontophoresis role in improving diabetic peripheral neuropathy
Time Frame: 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).
one month (baseline assessment and after one month of Ach iontophoresis and exercise)
Numerical rating pain scale
Time Frame: 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
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2023

Primary Completion (Estimated)

January 20, 2024

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ach Iontophoresis neuropathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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