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

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ClinicalTrials.gov Identifier: NCT02062034
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Alejandra Guillermina Miranda Diaz, University of Guadalajara

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.

Condition or disease Intervention/treatment Phase
Non-proliferative Diabetic Retinopathy Diabetes Mellitus Type 2 Drug: Ubiquinone Drug: Combined antioxidant therapy Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ubiquinone
400mg daily of oral ubiquinone for 24 weeks
Drug: Ubiquinone
400mg daily of oral ubiquinone for 24 weeks
Other Name: coenzyme Q10

Experimental: Combined antioxidant therapy
(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
Drug: Combined antioxidant therapy
(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 Comparator: Placebo
Placebo. 100mg daily oral intake for 24 weeks
Drug: Placebo
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Other Name: Inactive drug




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).




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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062034


Locations
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Mexico
Cardiovascular Research Unit, University of Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Instituto Mexicano del Seguro Social
Investigators
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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

Additional Information:
Publications of Results:
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Responsible Party: Alejandra Guillermina Miranda Diaz, PhD, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02062034     History of Changes
Other Study ID Numbers: RDNP-20100102
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Alejandra Guillermina Miranda Diaz, University of Guadalajara:
Oxidative stress
Mitochondrial dysfunction
Ubiquinone
Antioxidant combined therapy
Diabetic retinopathy
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus, Type 2
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Copper
Ubiquinone
Antioxidants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements