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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ferris State University
Sponsor:
Collaborator:
Retina Specialists of Michigan
Information provided by (Responsible Party):
Arinze Nkemdirim Okere, Ferris State University
ClinicalTrials.gov Identifier:
NCT01880372
First received: June 13, 2013
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Moderate Non-proliferative Diabetic Retinopathy
Dietary Supplement: Alpha Lipoic Acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Ferris State University:

Primary Outcome Measures:
  • Decreased progression of diabetic retinopathy. [ Time Frame: Visual examination and serum analysis will be done at baseline, 3 , 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Changes in the plasma level of glutathione as measured by ELISA technique [ Time Frame: Serum analysis done at baseline, 3, 6,9 and 12 month ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Changes in retinal thickness as measured by optical coherence tomography (OCT) [ Time Frame: Procedure done at baseline, 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]
  • Changes in visual acuity as measured by electronic visual testing algorithm [ Time Frame: Visual examination done at baseline, 3, 6, 9 and 12 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alpha Lipoic Acid
Alpha lipoic acid assignment group will follow routine care and receive 600 mg oral administration of lipoic acid daily. While the control group will follow routine care alone .
Dietary Supplement: Alpha Lipoic Acid
Same as Arm description
Other Name: ALA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diabetes type I and 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880372

Contacts
Contact: Holly Vincent, BS 6169542020 hvincent.rsm@gmail.com
Contact: Arinze Nkemdirim Okere, PharmD, MS 616-391-0863 arinzenkemdirimokere@ferris.edu

Locations
United States, Michigan
Retina Specialists of Michigan Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Thomas M Aaberg, MD    616-954-2020    thomasaaberg@comcast.net   
Contact: Holly Vincent, BS    (616)954-2020    hvincent.rsm@gmail.com   
Principal Investigator: Thomas Aaberg, MD         
Retina Specialists of Michigan Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Thomas M Aaberg, MD    616-954-2020    thomasaaberg@comcast.net   
Contact: Holly VIncent, BS    6169542020    hvincent.rsm@gmail.com   
Sponsors and Collaborators
Ferris State University
Retina Specialists of Michigan
Investigators
Principal Investigator: Arinze Nkemdirim Okere, PharmD, MS Ferris State University
  More Information

Additional Information:
No publications provided

Responsible Party: Arinze Nkemdirim Okere, Assistant Professor of Pharmacy, Ferris State University
ClinicalTrials.gov Identifier: NCT01880372     History of Changes
Other Study ID Numbers: FSU130106
Study First Received: June 13, 2013
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Ferris State University:
Diabetes
Diabetic Retinopathy
Retinopathy
Free radical
Retinal diseases
Antioxidants
Protective agents
Thioctic acid

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Vascular Diseases
Thioctic Acid
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014