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

Primary Purpose

Non-proliferative Diabetic Retinopathy, Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Ubiquinone
Combined antioxidant therapy
Placebo
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-proliferative Diabetic Retinopathy focused on measuring Oxidative stress, Mitochondrial dysfunction, Ubiquinone, Antioxidant combined therapy, Diabetic retinopathy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cardiovascular Research Unit, University of Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ubiquinone

Combined antioxidant therapy

Placebo

Arm Description

400mg daily of oral ubiquinone for 24 weeks

(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. 100mg daily oral intake for 24 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mitochondrial dysfunction markers
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)
Progression and regression of non-proliferative diabetic retinopathy
Evaluated with International clinical diabetic retinopathy disease severity scale, fluorescein angiography and color fundus photographs. Baseline and final stage.

Full Information

First Posted
July 17, 2013
Last Updated
February 11, 2014
Sponsor
University of Guadalajara
Collaborators
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT02062034
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
Collaborators
Instituto Mexicano del Seguro Social

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-proliferative Diabetic Retinopathy, Diabetes Mellitus Type 2
Keywords
Oxidative stress, Mitochondrial dysfunction, Ubiquinone, Antioxidant combined therapy, Diabetic retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ubiquinone
Arm Type
Experimental
Arm Description
400mg daily of oral ubiquinone for 24 weeks
Arm Title
Combined antioxidant therapy
Arm Type
Experimental
Arm Description
(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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo. 100mg daily oral intake for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ubiquinone
Other Intervention Name(s)
coenzyme Q10
Intervention Description
400mg daily of oral ubiquinone for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Combined antioxidant therapy
Other Intervention Name(s)
lutein, zeaxanthin, astaxanthin, vitamin C, vitamin E, zinc, copper
Intervention Description
(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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive drug
Intervention Description
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Primary Outcome Measure Information:
Title
Oxidative Stress markers
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mitochondrial dysfunction markers
Description
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)
Time Frame
24 weeks
Title
Progression and regression of non-proliferative diabetic retinopathy
Description
Evaluated with International clinical diabetic retinopathy disease severity scale, fluorescein angiography and color fundus photographs. Baseline and final stage.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Security profile
Description
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).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandra G. Miranda-Díaz, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
José A. Castellanos-González, M.Sc.
Organizational Affiliation
University of Guadalajara
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adolfo D. Rodriguez-Carrizalez, M.Sc.
Organizational Affiliation
University of Guadalajara
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiovascular Research Unit, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
22595020
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.
Results Reference
result
Links:
URL
http://clinicaltrials.gov/ct2/show/record/NCT01622777
Description
The effect of rosuvastatin in Diabetic Polyneuropathy: A Phase 2a Randomized Double-blind Placebo-controlled Study

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

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