Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02439879
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2015-05-04
Brief Title:
Alpha Lipoic Acid for Treatment of Diabetic Neuropathy
Sponsor:
Universidad Popular Autónoma del Estado de Puebla
Organization:
Universidad Popular Autónoma del Estado de Puebla
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with diabetic neuropathy and total symptoms scoreTSS 7 points were invited to this open multicenter study Patients were free of pain medications and severe diabetic complications Patients started alpha lipoic acid ALA1800 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
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 HbA1c10 and serum creatinine 2 mgdl 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 investigators 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 PharmaGermany 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
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 investigators 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 PharmaGermany 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None