Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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%).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Popular Autónoma del Estado de Puebla
• Treatments: Thioctic Acid

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