- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01880372
The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy (ALA-TPD)
Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Big Rapids, Michigan, United States, 49307
- Ferris State University
-
Grand Rapids, Michigan, United States, 49525
- Retina Specialists of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individual with diabetes mellitus type I or type II mild to moderate non-proliferative diabetic retinopathy which will be based on ETDRS grading scale
- Patient must be 18 years and older
Exclusion Criteria:
- Patients with severe non-proliferative or proliferative diabetic retinopathy
- Patients with macular edema
- Eye diseases that may interfere with visualization of the fundus such as preretinal hemorrhage, cataract, vitreous hemorrhage
- Patient that has undergone any type of interventional therapy for diabetic retinopathy (Such as laser photocoagulation, vitrectomy)
- Amblyopia
- Glaucoma
- Patient with cataract surgery within a period of 4 months
- Patients with other retinal diseases
- Patients on chronic administration of alpha lipoic acid
- Known intolerance/hypersensitivity to alpha lipoic acid
- Patient with history of dialysis in cases of renal insufficiency and history of kidney transplantation
- Malignancies or life threatening diseases as determined by the investigators
- Current history of drug or alcohol abuse
- Pregnant and breast feeding women
- Cognitively impaired patients
- Participation in a clinical trial within the last 30 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Same as Arm description
Other Names:
|
No Intervention: Alpha Lipoic Acid Control Group
The control group will follow routine care alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Visual examination and serum analysis will be done at baseline, 6 and 12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in the plasma level of glutathione as measured by ELISA technique
Time Frame: Serum analysis done at baseline, 6 and 12 month
|
Serum analysis done at baseline, 6 and 12 month
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in retinal thickness as measured by optical coherence tomography (OCT)
Time Frame: Procedure done at baseline, 6 and 12 month
|
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
|
Visual examination done at baseline, 6 and 12 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arinze Nkemdirim Okere, PharmD, MS, Florida A & M University, College of Pharmacy and Pharmaceutical sciences
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin B Complex
- Thioctic Acid
Other Study ID Numbers
- FSU130106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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