Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy
1 other identifier
interventional
61
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant therapy on progression, clinical regression, oxidative stress markers and mitochondrial dysfunction in non-proliferative diabetic retinopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 13, 2014
CompletedFebruary 13, 2014
February 1, 2014
2.8 years
July 17, 2013
February 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxidative Stress markers
In this study the oxidative stress markers are composed of lipid peroxidation, nitric oxide, erythrocyte glutathion peroxidase activity, erythrocyte catalase activity, total antioxidant capacity and erythrocyte membrane fluidity. * Lipid peroxidation (baseline and final values) given as malondialdehyde (MDA) and 4-hydroxyalkenals (4HDA) expressed in μmol/L * Nitric oxide (NO) Levels of the NO catabolites nitrites/nitrates expressed in pmol/mL (baseline and final values) * Erythrocyte glutathion peroxidase activity measured in U/min/mg protein (baseline and final values) * Erythrocyte catalase activity expressed in U/mg protein (baseline and final values) * Total antioxidant capacity measured in milliequivalent/mL (baseline and final values) * Erythrocyte membrane fluidity, calculated using the fluorescence ratio of the excimer (Ie) to monomer (Im). The Ie/Im ratio.
24 weeks
Secondary Outcomes (2)
Mitochondrial dysfunction markers
24 weeks
Progression and regression of non-proliferative diabetic retinopathy
24 weeks
Other Outcomes (1)
Security profile
24 weeks
Study Arms (3)
Ubiquinone
EXPERIMENTAL400mg daily of oral ubiquinone for 24 weeks
Combined antioxidant therapy
EXPERIMENTAL(1mg copper + 20mg zinc + 180mg vitamin C + 30mg vitamin E + 1mg zeaxanthin + 4mg astaxanthin + 10mg lutein) daily of oral antioxidant combined therapy for 24 weeks
Placebo
PLACEBO COMPARATORPlacebo. 100mg daily oral intake for 24 weeks
Interventions
(1 mg copper, 20 mg zinc, 180 mg vitamin C, 30 mg vitamin E, 1 mg zeaxanthin, 4 mg astaxanthin, 10 mg lutein) daily of oral, all of them in one Tablet for 24 weeks
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes mellitus
- Patients with non proliferative diabetic retinopathy
- Glycated hemoglobin \< 12.0%
- Signing of informed consent
You may not qualify if:
- Patients with clinically significant macular edema
- Patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy)
- Pretreatment with argon laser or excimer laser Ophthalmology surgery
- Any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration)
- Pregnancy, lactation, inadequate use of contraception
- Antioxidant drug and/or supplements six months previous to enrollment
- Renal and/or hepatic failure
- Age under 30 or over 75 years
- Severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy)
- Blood dyscrasias
- Have or have had cancer or other serious illness
- Neurodegenerative process
- Allergy to vitamins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Guadalajaralead
- Instituto Mexicano del Seguro Socialcollaborator
Study Sites (1)
Cardiovascular Research Unit, University of Guadalajara
Guadalajara, Jalisco, 44340, Mexico
Related Publications (1)
Hernandez-Ojeda J, Cardona-Munoz EG, Roman-Pintos LM, Troyo-Sanroman R, Ortiz-Lazareno PC, Cardenas-Meza MA, Pascoe-Gonzalez S, Miranda-Diaz AG. The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study. J Diabetes Complications. 2012 Jul-Aug;26(4):352-8. doi: 10.1016/j.jdiacomp.2012.04.004. Epub 2012 May 16.
PMID: 22595020RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alejandra G. Miranda-Díaz, PhD
University of Guadalajara
- STUDY CHAIR
José A. Castellanos-González, M.Sc.
University of Guadalajara
- STUDY CHAIR
Adolfo D. Rodriguez-Carrizalez, M.Sc.
University of Guadalajara
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 17, 2013
First Posted
February 13, 2014
Study Start
February 1, 2011
Primary Completion
November 1, 2013
Study Completion
January 1, 2014
Last Updated
February 13, 2014
Record last verified: 2014-02