Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy

Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters

Patients with type 2 DM who are following will be enrolled into the study. Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of alpha lipoic acid (ALA) administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetic Polyneuropathy
• Intervention / Treatment: Drug: Alpha lipoic acid

Detailed Description

This prospective, Interventional study will be conducted at Benha university hospital for 3 months. Patients with type 2 DM who are following at the outpatient internal medicine & diabetes Clinics in Benha Univeristy Hospital and are eligible to participate, will be enrolled into the study. Inclusion criteria comprise the following(1) patient's agreement to participate; (2) diabetic peripheral neuropathy diagnosis (3) treatment with alpha lipolic acid (ALA), had to be stable for 3 months during the study.

Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of ALA administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).

evaluation include:

1. full neurological evaluation including motor, sensory, ankle reflex, Tests for cardiac parasympathetic action
2. nerve conduction study
3. neuromuscular ultrasound
4. HbA1C 5- HDL-C& LDL-C

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qalubiya
    • Banhā, Qalubiya, Egypt, 13518
      • Benha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient's agreement to participate
• Diabetic peripheral neuropathy

Exclusion Criteria:

• Causes of neuropathy other than diabetes
• Severe renal disease
• Recent treatment for cancer or haematological malignancies;
• Presence of foot ulcers;
• Peripheral arterial disease ;
• Use of agents in the previous 3 months that could interfere with the interpretation of results, such as opiates, vitamin B compounds or antioxidants;
• Pregnancy
• Lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: type 2 DM with peripheral neuropathy; 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.	Drug: Alpha lipoic acid; Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication; Other Names: Thiotacid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monofilament test of both feet	5.07 (10 gram) monofilament will be used to test loss of protective sensation of at 10 sites in each feet at baseline and after use of alpha lipoic acid. the score range from 0 (worst) to 10 (best)	: through study completion, an average of 3months
Vibration Perception Threshold (VPT)	VPT was evaluated using a 128-Hz tuning fork applied bilaterally at the tip of the great toe. Responses were categorized as abnormal (no perception of vibration),present (examiner perceives vibration <10sec after patient reported disappearance of vibration perception) ,and reduced (examiner perceives vibration >10 seconds after patient reported disappearance of vibration perception).	: through study completion, an average of 3 months
neuromuscular ultrasound	the cross sectional area of the posterior tibial nerve will be assessed in both sides at baseline and after use of alpha lipoic acid	: through study completion, an average of 3 months
concentration of Hemoglobin A1c	the participants were divided into two categories that include good glycemic control (HA1c≤7%), poor glycemic control (≥ HA1c 7 %),	: through study completion, an average of 3 months
serum concentrations of high density lipoproteins-cholesterol (HDL-C)	A low HDL cholesterol level was defined as <1.03 mmol/l( 40 mg/dl) for men and <1.29mmol/L(50 mg/dl) for women	: through study completion, an average of 3 months
serum concentrations of low density lipoproteins-cholesterol (LDL-C)	a patient of LDL-C equal or more than 3.3mmol/L (129mg/dl) is defined as dyslipidemic.	: through study completion, an average of 3 months
ankle reflex	ranging from 0 (absent) to 4 (hyperactive with clonus)	: through study completion, an average of 3 months
Measurement of nerve conduction velocity	sensory and motor conduction velocity are measured in meter/second in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid	: through study completion, an average of 3 months
measurement of Compound Muscle Action Potential (CMAP) amplitudes	amplitude is measured in micro or millivolts in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid	: through study completion, an average of 3 months
measurement of Compound Muscle Action Potential (CMAP) distal latency	distal latency measured in milliseconds and evaluated in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid	: through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Amira Mohamady, MD, Benha university- Qaluibya- Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2020
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): December 23, 2020

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: Benha22020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No