Non-proliferative Diabetic RetinopathyPhase 2NCT02062034
Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy
A Phase 2 study testing Ubiquinone and Combined antioxidant therapy in people with Non-proliferative Diabetic Retinopathy and Diabetes Mellitus Type 2, run by University of Guadalajara at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy, Diabetes Mellitus Type 2
- What is being tested?
- Ubiquinone and Combined antioxidant therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2011to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus
- Patients with non proliferative diabetic retinopathy
- Glycated hemoglobin < 12.0%
- Signing of informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Cardiovascular Research Unit, University of Guadalajara
Guadalajara, Jalisco, 44340
About this study
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
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.
Read the 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.
- Being tested
- Ubiquinone, Combined antioxidant therapy, Placebo
- Keywords
- Oxidative stress, Mitochondrial dysfunction, Ubiquinone, Antioxidant combined therapy, Diabetic retinopathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Mitochondrial Diseases, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbiquinoneDrug
Also called coenzyme Q10
400mg daily of oral ubiquinone for 24 weeks
Combined antioxidant therapyDrug
Also called lutein, zeaxanthin, astaxanthin, vitamin C
(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
PlaceboDrug
Also called Inactive drug
100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ubiquinone | Experimental | 400mg daily of oral ubiquinone for 24 weeks Receives: Drug: Ubiquinone |
| Combined antioxidant therapy | Experimental | (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 Receives: Drug: Combined antioxidant therapy |
| Placebo | Placebo comparator | Placebo. 100mg daily oral intake for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (2)
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)
Measured: 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, Alejandra Guillermina Miranda Diaz, University of Guadalajara
- Investigators
- Alejandra G. Miranda-Díaz, PhD, Study director, University of GuadalajaraJosé A. Castellanos-González, M.Sc., Study chair, University of GuadalajaraAdolfo D. Rodriguez-Carrizalez, M.Sc., Study chair, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062034
- Sponsor's protocol ID
- RDNP-20100102
- Status last verified
- Feb 2014
- First submitted
- 17 Jul 2013
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22595020
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02062034
- Acronym / sponsor ID
- RDNP-20100102
- Keywords
- Oxidative stress, Mitochondrial dysfunction, Ubiquinone, Antioxidant combined therapy, Diabetic retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ubiquinone | Experimental | Drug: Ubiquinone400mg daily of oral ubiquinone for 24 weeks |
| Combined antioxidant therapy | Experimental | Drug: 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 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo. 100mg daily oral intake for 24 weeks |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes mellitus
- Patients with non proliferative diabetic retinopathy
- Glycated hemoglobin < 12.0%
- Signing of informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UbiquinoneAlso: coenzyme Q10400mg daily of oral ubiquinone for 24 weeks | Drug | Ubiquinone |
| Combined antioxidant therapyAlso: lutein, zeaxanthin, astaxanthin, vitamin C(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 | Drug | Combined antioxidant therapy |
| PlaceboAlso: Inactive drug100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Mitochondrial dysfunction markers
Time frame: 24 weeks
Progression and regression of non-proliferative diabetic retinopathy
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Results publication: PubMed 22595020Hernandez-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.
- The effect of rosuvastatin in Diabetic Polyneuropathy: A Phase 2a Randomized Double-blind Placebo-controlled StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra G. Miranda-Díaz, PhD study director
University of Guadalajara
José A. Castellanos-González, M.Sc. study chair
University of Guadalajara
Adolfo D. Rodriguez-Carrizalez, M.Sc. study chair
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ubiquinone and Combined antioxidant therapy in people with Non-proliferative Diabetic Retinopathy and Diabetes Mellitus Type 2, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative Stress markers (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.