The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy (ALA-TPD)

February 12, 2019 updated by: Ferris State University

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

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

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Big Rapids, Michigan, United States, 49307
        • Ferris State University
      • Grand Rapids, Michigan, United States, 49525
        • Retina Specialists of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • ALA
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arinze Nkemdirim Okere, PharmD, MS, Florida A & M University, College of Pharmacy and Pharmaceutical sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

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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