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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062034
• Other study ID #: RDNP-20100102
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2013
• Last updated: February 11, 2014
• Start date: February 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Non-proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Ubiquinone
400mg daily of oral ubiquinone for 24 weeks
• 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
• Placebo
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks

Locations

Country	Name	City	State
Mexico	Cardiovascular Research Unit, University of Guadalajara	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
University of Guadalajara	Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Hernández-Ojeda J, Cardona-Muñoz EG, Román-Pintos LM, Troyo-Sanromán R, Ortiz-Lazareno PC, Cárdenas-Meza MA, Pascoe-González S, Miranda-Díaz AG. The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study. J Dia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Security profile	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
Primary	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.	24 weeks
Secondary	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)	24 weeks
Secondary	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.	24 weeks

External Links

•   The effect of rosuvastatin in Diabetic Polyneuropathy: A Phase 2a Randomized Double-blind Placebo-controlled Study