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Trial record 1 of 13 for:    Alpha Lipoic Acid | Neuropathy, Diabetic
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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Neuropathy
Intervention Drug: Alpha lipoic acid
Enrollment 45
Recruitment Details Type 2 diabetic patients with symptomatic neuropathic symptoms from 3 medical clinics in Puebla city, Mexico (one private, 2 public) were invited direct by investigator to participate if they fulfill inclusion criteria and no exclusion criteria. First patient was included on January 8th 2010 and the last visit of one patient was on December 2010
Pre-assignment Details All patients meeting inclusion criteria received 600 mg of alfa-lipoic acid orally tid for 4 weeks. 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 who used other neuropathic pain drugs were excluded from study phase 2.
Arm/Group Title Alpha Lipoic Acid Treatment Alpha Lipoic Acid Withdrawal
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 16 17
Completed 16 17
Not Completed 0 0
Arm/Group Title Alpha Lipoic Acid Treatment Alpha Lipoic Acid Withdrawal Total
Hide Arm/Group Description

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

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.

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 Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
57.5  (10) 59  (11) 58.4  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
11
  68.8%
11
  64.7%
22
  66.7%
Male
5
  31.3%
6
  35.3%
11
  33.3%
TSS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 17 participants 33 participants
3.7  (1.97) 3.23  (2.07) 3.45  (2)
[1]
Measure Description: Total Symptoms Score TSS, which is a summation of the presence, severity,and duration of lancinating pain, burning pain, prickling, and asleep numbness. Each of these is a positive neuropathic sensory symptom. Scoring: total score 0-14.64. Any increase in the score means a worsening of symptoms
1.Primary Outcome
Title Total Symptoms Score
Hide Description 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
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alpha Lipoic Acid Treatment Alpha Lipoic Acid Withdrawal
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 16 17
Mean (Standard Error)
Unit of Measure: units on a scale
2.5  (0.6) 3.1  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alpha Lipoic Acid Treatment, Alpha Lipoic Acid Withdrawal
Comments All data were analyzed using the SPSS v16 statistical package software. To compare categorical variables, the chi2 test was used, and, for continuous variables,the T-test for independent or paired samples was applied.Data are expressed as percent values with 95% confidence intervals (CI) or mean ± SD or mean ± SEM
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method paired t test
Comments [Not Specified]
Time Frame 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alpha Lipoic Acid Treatment Alpha Lipoic Acid Withdrawal
Hide Arm/Group Description 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 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
All-Cause Mortality
Alpha Lipoic Acid Treatment Alpha Lipoic Acid Withdrawal
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Alpha Lipoic Acid Treatment Alpha Lipoic Acid Withdrawal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alpha Lipoic Acid Treatment Alpha Lipoic Acid Withdrawal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hector Garcia Alcala
Organization: Universidad Popular Autonoma del Estado de Puebla
Phone: +522222299400 ext 7466
EMail: hector.garcia@upaep.mx
Layout table for additonal information
Responsible Party: Hector Garcia-Alcala, Universidad Popular Autónoma del Estado de Puebla
ClinicalTrials.gov Identifier: NCT02439879    
Other Study ID Numbers: UPAEP25082009
First Submitted: May 4, 2015
First Posted: May 12, 2015
Results First Submitted: December 1, 2015
Results First Posted: March 2, 2016
Last Update Posted: March 2, 2016