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

NCT04322240 | Completed

• 1 other identifier: Benha22020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Polyneuropathy; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

type 2 DM with peripheral neuropathy

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.

Drug: Alpha lipoic acid

Interventions

Alpha lipoic acid DRUG

Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication

Also known as: Thiotacid

type 2 DM with peripheral neuropathy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's agreement to participate
• Diabetic peripheral neuropathy

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13518, Egypt

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Amira Mohamady, MD

  Benha university- Qaluibya- Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: April 2, 2020
• Primary Completion: October 23, 2020
• Study Completion: December 23, 2020
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)