The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy (ALA-TPD)
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|ClinicalTrials.gov Identifier: NCT01880372|
Recruitment Status : Suspended (Low number of patients enrolled)
First Posted : June 19, 2013
Last Update Posted : May 19, 2016
The purpose of this study is to evaluate the role of alpha lipoic acid in patients who have moderate non-proliferative diabetic retinopathy.
The primary aim of this study is to test the hypothesis that the addition of alpha lipoic acid in a diabetic patient's therapeutic regimen can decrease the progression of diabetic retinopathy and preserve visual acuity.
|Condition or disease||Intervention/treatment||Phase|
|Moderate Non-proliferative Diabetic Retinopathy||Dietary Supplement: Alpha Lipoic Acid||Phase 1 Phase 2|
Increased production of free radicals and depletion of antioxidants are commonly observed in diabetic patients. Based on animal studies, increased production of free radicals tends to persist even after blood glucose is tightly controlled. The rationale of using a potent antioxidant is based on the observation that increased oxidative stress associated with hyperglycemia can contribute to cellular injury leading to apoptosis; consequently, leading to diabetic retinopathy. Evidence from animal model showed that alpha lipoic acid (a potent antioxidant) was effective for decreasing the progression of diabetic retinopathy and in reducing free radicals.
Therefore, we hypothesize that therapy that can exert a powerful antioxidant activity can provide a therapeutic modality needed to target the pathogenesis of diabetic retinopathy.
This study will be a 12-month pilot study demonstrating the role of alpha lipoic acid in patients who have moderate non-proliferative diabetic retinopathy.
Eligible patients will be randomized to two groups, treatment and control groups. Patients in the treatment group will receive 600 mg of alpha lipoic acid daily with routine care while patient in control group will only follow routine care. Optical coherence tomography (OCT)and electronic visual acuity testing algorithm (ETDRS) will be used to measure changes in retinal thickness and visual acuity respectively. Blood changes in macrophage colony stimulating factor (M-CSF), vascular endothelia growth factor (VEGF), Interferon 2 alpha, interleukin 6 and 8 will also be evaluated and compared between the two groups. Descriptive statistics and intention to treat analysis will be used to compare treatment and control groups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
Experimental: Alpha Lipoic Acid Assignment Group
Alpha lipoic acid assignment group will follow routine care and receive 600 mg oral administration of lipoic acid daily.
Dietary Supplement: Alpha Lipoic Acid
Same as Arm description
Other Name: ALA
No Intervention: Alpha Lipoic Acid Control Group
The control group will follow routine care alone.
- Decreased progression of diabetic retinopathy. [ Time Frame: Visual examination and serum analysis will be done at baseline, 6 and 12 month ]Decreased progression of diabetic retinopathy as measured and graded by using Standard ETDRS 7 -field color stereoscopic funds photograph, and also by measuring the serum levels of interleukin 6 and 8, VEGF, interferon 2 alpha and M-CSF using ELISA technique
- Changes in the plasma level of glutathione as measured by ELISA technique [ Time Frame: Serum analysis done at baseline, 6 and 12 month ]
- Changes in retinal thickness as measured by optical coherence tomography (OCT) [ Time Frame: Procedure done at baseline, 6 and 12 month ]
- Changes in visual acuity as measured by electronic visual testing algorithm [ Time Frame: Visual examination done at baseline, 6 and 12 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880372
|United States, Michigan|
|Ferris State University|
|Big Rapids, Michigan, United States, 49307|
|Retina Specialists of Michigan|
|Grand Rapids, Michigan, United States, 49525|
|Principal Investigator:||Arinze Nkemdirim Okere, PharmD, MS||Florida A & M University, College of Pharmacy and Pharmaceutical sciences|