Skip to main content
OpenTrials
Completed

NCT Number: NCT02062034

Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Proliferative Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Mitochondrial Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardiovascular Research Unit, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ubiquinone

Drug

400mg daily of oral ubiquinone for 24 weeks

Other names: coenzyme Q10

Combined antioxidant therapy

Drug

(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

Other names: lutein, zeaxanthin, astaxanthin, vitamin C, vitamin E, zinc, copper

Placebo

Drug

100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks

Other names: Inactive drug

Primary outcomes

  1. Oxidative Stress markers

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. Mitochondrial dysfunction markers

    Time frame: 24 weeks

    In this study the mitochondrial dysfunction markers are composed of hydrolysis of adenosine triphosphate and membrane fluidity in submitochondrial particles of platelets.

    • Hydrolysis of adenosine triphosphate: The hydrolytic activity of mitochondrial F0/F1-ATPase (F0/F1-adenosine triphosphatase) was measured as the liberation of inorganic phosphate from platelet mitochondria. Expressed in nmol of phosphate. Baseline and final values.
    • Membrane fluidity in submitochondrial particles of platelets. Calculated usig the fluorescence ratio of the excimer (Ie) to monomer (Im). The Ie/Im ratio. (Baseline and final values)

  2. Progression and regression of non-proliferative diabetic retinopathy

    Time frame: 24 weeks

    Evaluated with International clinical diabetic retinopathy disease severity scale, fluorescein angiography and color fundus photographs.

    Baseline and final stage.

Other outcomes

  1. Security profile

    Time frame: 24 weeks

    In this study the security profile markers are composed of intraocular pressure, visual acuity, renal function, and liver profile.

    Intraocular pressure. expressed in mmHg (baseline and final values) Visual acuity measured in decimal scale (baseline and final values) Renal function: serum urea (mg/dL), serum creatinine (mg/dL). (Baseline and final values) Liver profile: total serum bilirubin (mg/dL), indirect bilirubin (mg/dL), direct bilirubin (mg/dL) (Baseline and final values).

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

  • Instituto Mexicano del Seguro Social

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 13, 2014
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.