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

February 11, 2014 updated by: Alejandra Guillermina Miranda Diaz, University of Guadalajara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Cardiovascular Research Unit, University of Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ubiquinone
400mg daily of oral ubiquinone for 24 weeks
Drug: Ubiquinone
400mg daily of oral ubiquinone for 24 weeks
Other Names:
  • 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:
  • vitamin C
  • astaxanthin
  • lutein
  • zinc
  • zeaxanthin
  • vitamin E
  • 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 Names:
  • Inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 weeks
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.
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Collaborators

Instituto Mexicano del Seguro Social

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDNP-20100102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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