Completed

Alpha Lipoic Acid Treatment for Diabetic Peripheral Neuropathy: Impact on Metabolic Parameters

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Study Aim

This study aims to evaluate the impact of Alpha Lipoic Acid treatment on diabetic peripheral neuropathy, focusing on improvements in nerve function, ankle reflex, and metabolic parameters such as Hemoglobin A1c and cholesterol levels in individuals with diabetes.

What is being tested

Alpha lipoic acid

Drug
Who is being recruted

Diabetes Mellitus+8

+ Diabetes Mellitus, Type 2

+ Diabetic Neuropathies

Over 16 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2020
See protocol details

Summary

Principal SponsorBenha University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 2, 2020

Actual date on which the first participant was enrolled.

This study focuses on the potential benefits of Alpha Lipoic Acid (ALA) for individuals with type 2 diabetes who also have peripheral neuropathy, a condition that causes nerve damage, typically in the hands and feet. The research takes place at Benha University Hospital and spans three months. Participants must have a stable treatment regimen with ALA. The goal is to understand how ALA might affect various metabolic parameters and peripheral neuropathy symptoms, potentially improving diabetes management. During the study, participants undergo two visits: one before starting ALA treatment and another after three months. Each visit involves a full neurological evaluation, physical examination, and laboratory tests. The evaluations include assessment of reflexes, nerve function tests, and blood tests to measure HbA1C, HDL-C, and LDL-C levels. The primary outcomes measured include changes in ankle reflex, nerve conduction velocity, nerve cross-sectional area, and vibration perception. The study also monitors the concentration of Hemoglobin A1c, an indicator of average blood sugar levels, and the levels of good (HDL-C) and bad (LDL-C) cholesterol.

Official TitleAlpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters
NCT04322240
Principal SponsorBenha University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Diabetic NeuropathiesEndocrine System DiseasesMetabolic DiseasesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesPeripheral Nervous System DiseasesGlucose Metabolism DisordersDiabetes Complications

Criteria

2 inclusion criteria required to participate
Patient's agreement to participate

Diabetic peripheral neuropathy

8 exclusion criteria prevent from participating
Causes of neuropathy other than diabetes

Severe renal disease

Recent treatment for cancer or haematological malignancies;

Presence of foot ulcers;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication, antidiabetic drugs, or medications used for managing arterial hypertension or dyslipidaemia during the study.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Benha University Hospital

Banhā, EgyptOpen Benha University Hospital in Google Maps
CompletedOne Study Center