Clinical trial NCT02062034: Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy
Official title: Efficacy of Ubiquinone and Combined Antioxidant Therapy on Progression, Oxidative Stress Markers and Mitochondrial Dysfunction in Non-proliferative Diabetic Retinopathy: A Phase 2a Randomized Double-blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-proliferative Diabetic Retinopathy
Diabetes Mellitus Type 2
Keywords: Oxidative stress
Mitochondrial dysfunction
Ubiquinone
Antioxidant combined therapy
Diabetic retinopathy
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2014-02-13
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The investigators are interested in demonstrating the efficacy of Ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Patients with non proliferative diabetic retinopathy
* Glycated hemoglobin \< 12.0%
* Signing of informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oxidative Stress markers
timeFrame: 24 weeks
Secondary outcomes:
measure: Mitochondrial dysfunction markers
timeFrame: 24 weeks
measure: Progression and regression of non-proliferative diabetic retinopathy
timeFrame: 24 weeks
Other outcomes:
measure: Security profile
timeFrame: 24 weeks
Locations:
city: Guadalajara
country: Mexico
facility: Cardiovascular Research Unit, University of Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Alejandra G. Miranda-Díaz, PhD
role: STUDY_DIRECTOR
affiliation: University of Guadalajara
name: José A. Castellanos-González, M.Sc.
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Adolfo D. Rodriguez-Carrizalez, M.Sc.
role: STUDY_CHAIR
References:
citation: 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.