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

Primary Purpose

Diabetic Polyneuropathy, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Alpha lipoic acid
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Benha University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

type 2 DM with peripheral neuropathy

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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).
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
concentration of Hemoglobin A1c
the participants were divided into two categories that include good glycemic control (HA1c≤7%), poor glycemic control (≥ HA1c 7 %),
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
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.
ankle reflex
ranging from 0 (absent) to 4 (hyperactive with clonus)
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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
December 29, 2020
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04322240
Brief Title
Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy
Official Title
Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

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

5. Study Description

Brief 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).
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: full neurological evaluation including motor, sensory, ankle reflex, Tests for cardiac parasympathetic action nerve conduction study neuromuscular ultrasound HbA1C 5- HDL-C& LDL-C

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
type 2 DM with peripheral neuropathy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alpha lipoic acid
Other Intervention Name(s)
Thiotacid
Intervention Description
Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication
Primary Outcome Measure Information:
Title
monofilament test of both feet
Description
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)
Time Frame
: through study completion, an average of 3months
Title
Vibration Perception Threshold (VPT)
Description
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).
Time Frame
: through study completion, an average of 3 months
Title
neuromuscular ultrasound
Description
the cross sectional area of the posterior tibial nerve will be assessed in both sides at baseline and after use of alpha lipoic acid
Time Frame
: through study completion, an average of 3 months
Title
concentration of Hemoglobin A1c
Description
the participants were divided into two categories that include good glycemic control (HA1c≤7%), poor glycemic control (≥ HA1c 7 %),
Time Frame
: through study completion, an average of 3 months
Title
serum concentrations of high density lipoproteins-cholesterol (HDL-C)
Description
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
Time Frame
: through study completion, an average of 3 months
Title
serum concentrations of low density lipoproteins-cholesterol (LDL-C)
Description
a patient of LDL-C equal or more than 3.3mmol/L (129mg/dl) is defined as dyslipidemic.
Time Frame
: through study completion, an average of 3 months
Title
ankle reflex
Description
ranging from 0 (absent) to 4 (hyperactive with clonus)
Time Frame
: through study completion, an average of 3 months
Title
Measurement of nerve conduction velocity
Description
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
Time Frame
: through study completion, an average of 3 months
Title
measurement of Compound Muscle Action Potential (CMAP) amplitudes
Description
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
Time Frame
: through study completion, an average of 3 months
Title
measurement of Compound Muscle Action Potential (CMAP) distal latency
Description
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
Time Frame
: through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Mohamady, MD
Organizational Affiliation
Benha university- Qaluibya- Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha University Hospital
City
Banhā
State/Province
Qalubiya
ZIP/Postal Code
13518
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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