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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04322240
• Other study ID #: Benha22020
• Status: Completed
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: December 23, 2020

Study information

• Verified date: December 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha University Hospital	Banha	Qalubiya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	ankle reflex	ranging from 0 (absent) to 4 (hyperactive with clonus)	: through study completion, an average of 3 months
Primary	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
Primary	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
Primary	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