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Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439879
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hector Garcia-Alcala, Universidad Popular Autónoma del Estado de Puebla

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%).

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Drug: Alpha lipoic acid Phase 4

Detailed Description:

This trial was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of Universidad Popular Autónoma del Estado de Puebla, Mexico. All participants provided a written informed consent. Type 2 diabetic patients (according to American Diabetes Association (ADA) criteria) with symptomatic diabetic sensorimotor polyneuropathy (DSPN) defined as the presence of neuropathic symptoms (pain, paresthesias, or numbness) were invited to participate in this open-label multicenter trial. Inclusion criteria were: total symptom score (TSS) >7 points, HbA1c<10%, and serum creatinine <2 mg/dl. Exclusion criteria were evidence of active cardiovascular disease, malignancy, or any other conditions causing neuropathic pain, use of analgesic, antidepressant, or antiepileptic drugs, or any other medication aimed to relief neuropathic pain. In addition, child-bearing female patients not using any effective birth control method and under surveillance of a board-certified gynecologist were excluded.

Phase 1. All patients meeting inclusion criteria received 600 mg of alpha lipoic acid (ALA) (Meda Pharma, Germany) orally tid, 30 min after each main meal for 4 weeks. During phase 1, no medication for relief of neuropathic pain was allowed. Each participating site was in charge to maintain glycemic control based on the investigator's judgment attempting that all patients were treated according to the american diabetes association (ADA) guidelines. All patients were seen once a week, and at each site visit, TSS was assessed along with a pill count to ensure drug adherence, presence of adverse events and, if needed, treatment adjustments to maintain glucose levels within the ADA targets. Patients with a TSS reduction >3 points by the end of phase 1 were selected to proceed with phase 2 of the study. Patients with a decrease <3 points in TSS or that used other neuropathic pain drugs were excluded from study phase 2.

Phase 2. Patients with a decrease of ≥3 TSS points after phase 1 were randomized to receive 600 mg of ALA orally qd for 16 weeks or ALA withdrawal. Patients were scheduled to visit the clinic every 2-3 weeks for TSS, monofilament and assessment. If needed, the patient was prescribed analgesic rescue medication which was monitored at each visit. Primary endpoint was the change in TSS in the two groups studied in phase 2 and the frequency of use of rescue medications Neurological examination was performed at baseline and after phase 1 and 2 including the monofilament test, vibration perception threshold (VPT), and ankle reflexes. A 10g nylon monofilament (Thio-Feel ® Meda Pharma, Germany) was applied to four anatomical sites in each foot (1st, 3rd and 5th metatarsal heads and plantar surface of distal hallux) as previously described (correct answer = 1 point, with a maximum of 4 points in each foot). Eight correct answers were considered normal, 1-7 correct answers indicated reduced monofilament sensation, while absent sensation was assumed if no answer was correct. VPT was evaluated using a 128-Hz tuning fork (Thio-Vib ®, Meda Pharma,Germany) applied bilaterally at the tip of the great toe. Responses were categorized as abnormal (no perception of vibration), present (examiner perceives vibration <10 seconds after patient reported disappearance of vibration perception) and reduced (examiner perceives vibration >10 sec after patient reported disappearance of vibration perception). Ankle reflexes were graded as normal, decreased, and absent

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: alpha lipoic acid treatment
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 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.
Other Names:
  • Thioctic acid
  • Thioctacid HR

No Intervention: alpha lipoic acid withdrawal
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



Primary Outcome Measures :
  1. Total Symptoms Score [ Time Frame: 20 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439879


Sponsors and Collaborators
Universidad Popular Autónoma del Estado de Puebla
Investigators
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Principal Investigator: Hector Garcia-Alcala, MD Universidad Popular Autonoma del Estado de Puebla

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hector Garcia-Alcala, Endocrinology professor, Universidad Popular Autónoma del Estado de Puebla
ClinicalTrials.gov Identifier: NCT02439879    
Other Study ID Numbers: UPAEP25082009
First Posted: May 12, 2015    Key Record Dates
Results First Posted: March 2, 2016
Last Update Posted: March 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances