Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

NCT02439879 | Completed Phase 4 Results

• 1 other identifier: UPAEP25082009
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with diabetic neuropathy and total symptoms score(TSS) \>7 points were invited to this open multicenter study. Patients were free of pain medications and severe diabetic complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a decrease \>3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and the frequency of use of rescue medications. Physicians were free to manage glucose to maintain Hba1c close to the ADA target (HbA1c \<7%).

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Total Symptoms Score

  Total symptoms score is a summation of presence, severity, and duration of the four main positive neuropathic sensory symptoms: lancinating/stabbing pain, burning pain, paresthesia, and asleep numbness

  20 weeks

Study Arms (2)

alpha lipoic acid treatment

ACTIVE COMPARATOR

After a decrease in the total symptoms score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid

Drug: Alpha lipoic acid

alpha lipoic acid withdrawal

NO INTERVENTION

After a decrease in the total symptoms Score \>3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment

Interventions

Alpha lipoic acid DRUG

Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased \>3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks.

Also known as: Thioctic acid, Thioctacid HR

alpha lipoic acid treatment

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetic patients (according to American Diabetes Association (ADA) criteria)
• Symptomatic diabetic polyneuropathy
• Total Symptom Score (TSS) \>7 points,
• HbA1c\<10%,
• Serum creatinine \<2 mg/dl.

You may not qualify if:

• Active cardiovascular disease
• Malignancy
• Any other conditions causing neuropathic pain
• Use of analgesic, antidepressant, or antiepileptic drugs, or any other medication aimed to relief neuropathic pain.
• Child-bearing female patients not using any effective birth control method and under surveillance of a board-certified gynecologist

Sponsors & Collaborators

• Universidad Popular Autónoma del Estado de Puebla: lead

Related Publications (7)

• Papanas N, Ziegler D. Efficacy of alpha-lipoic acid in diabetic neuropathy. Expert Opin Pharmacother. 2014 Dec;15(18):2721-31. doi: 10.1517/14656566.2014.972935. Epub 2014 Nov 10.

  PMID: 25381809 BACKGROUND

• Ziegler D, Papanas N, Vinik AI, Shaw JE. Epidemiology of polyneuropathy in diabetes and prediabetes. Handb Clin Neurol. 2014;126:3-22. doi: 10.1016/B978-0-444-53480-4.00001-1.

  PMID: 25410210 RESULT

• Brownrigg JR, de Lusignan S, McGovern A, Hughes C, Thompson MM, Ray KK, Hinchliffe RJ. Peripheral neuropathy and the risk of cardiovascular events in type 2 diabetes mellitus. Heart. 2014 Dec;100(23):1837-43. doi: 10.1136/heartjnl-2014-305657. Epub 2014 Aug 5.

  PMID: 25095826 RESULT

• Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.

  PMID: 25575710 RESULT

• Ziegler D, Buchholz S, Sohr C, Nourooz-Zadeh J, Roden M. Oxidative stress predicts progression of peripheral and cardiac autonomic nerve dysfunction over 6 years in diabetic patients. Acta Diabetol. 2015 Feb;52(1):65-72. doi: 10.1007/s00592-014-0601-3. Epub 2014 Jun 5.

  PMID: 24898524 RESULT

• Ziegler D, Low PA, Litchy WJ, Boulton AJ, Vinik AI, Freeman R, Samigullin R, Tritschler H, Munzel U, Maus J, Schutte K, Dyck PJ. Efficacy and safety of antioxidant treatment with alpha-lipoic acid over 4 years in diabetic polyneuropathy: the NATHAN 1 trial. Diabetes Care. 2011 Sep;34(9):2054-60. doi: 10.2337/dc11-0503. Epub 2011 Jul 20.

  PMID: 21775755 RESULT

• Garcia-Alcala H, Santos Vichido CI, Islas Macedo S, Genestier-Tamborero CN, Minutti-Palacios M, Hirales Tamez O, Garcia C, Ziegler D. Treatment with alpha-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading. J Diabetes Res. 2015;2015:189857. doi: 10.1155/2015/189857. Epub 2015 Aug 4.

  PMID: 26345602 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Hector Garcia Alcala
• Organization: Universidad Popular Autonoma del Estado de Puebla

hector.garcia@upaep.mx

+522222299400

Study Officials

• Hector Garcia-Alcala, MD

  Universidad Popular Autonoma del Estado de Puebla

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinology professor

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 2, 2016
• Results First Posted: March 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share