Diabetic PolyneuropathyPhase 2NCT01622777
The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study
A Phase 2 study testing Rosuvastatin in people with Diabetic Polyneuropathy, run by Alejandra Guillermina Miranda Diaz at 1 site in Mexico.
Trial summary
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2010to Jun 2011
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus
- Glycated hemoglobin <12.0%
- Signing of informed consent
- Presence of an abnormality of nerve conduction study
- Symptoms and signs of diabetic polyneuropathy
Who cannot join
- Pregnancy and lactation
- Foot ulcers
- Treatment with statins
- Antioxidant drug and/or supplements one month previous to enrolment
- Inability to mobilize
- Renal and/or hepatic failure
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: Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Rosuvastatin, Placebo
- Keywords
- Rosuvastatin, Diabetic polyneuropathy, Nerve conduction, Oxidative stress, Nerve growth factor
- Medical subject headings
- Diabetic Neuropathies, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
20 mg daily of oral rosuvastatin for 12 weeks
PlaceboDrug
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | 20 mg daily of oral rosuvastatin Receives: Drug: Rosuvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of diabetic polyneuropathy
Measured: 12 weeks
Severity of diabetic polyneuropathy
Severity according nerve conduction studies
Measured: 12 weeks
Nerve conduction studies
Measured: 12 weeks
Neuropathy symptoms and impairment scores
Measured: 12 weeks
Lipid peroxidation
Measured: 12 weeks
Nerve growth factor
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alejandra Guillermina Miranda Diaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alejandra Guillermina Miranda Diaz, University of Guadalajara
- Investigators
- Ernesto G. Cardona-Muñoz, MD, PhD, Study director, University of GuadalajaraLuis Miguel Roman-Pintos, MD,PhD, Study chair, University of GuadalajaraRogelio Troyo-Sanroman, PhD, Study chair, University of GuadalajaraMaría del Pilar Alatorre-Carranza, PhD, Study chair, Hospital Civil de GuadalajaraAlejandra G. Miranda-Diaz, MD, PhD, Study director, University of GuadalajaraJaime Hernandez-Ojeda, MD, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622777
- Sponsor's protocol ID
- ROSU001
- Status last verified
- Jun 2012
- First submitted
- 15 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT01622777
- Acronym / sponsor ID
- ROSU001
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Rosuvastatin, Diabetic polyneuropathy, Nerve conduction, Oxidative stress, Nerve growth factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Alejandra Guillermina Miranda DiazUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Jun 2012 (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.
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin20 mg daily of oral rosuvastatin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type 2 diabetes mellitus
- Glycated hemoglobin <12.0%
- Signing of informed consent
- Presence of an abnormality of nerve conduction study
- Symptoms and signs of diabetic polyneuropathy
Key exclusion criteria (6 listed)
- Pregnancy and lactation
- Foot ulcers
- Treatment with statins
- Antioxidant drug and/or supplements one month previous to enrolment
- Inability to mobilize
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 |
|---|---|---|
| Rosuvastatin20 mg daily of oral rosuvastatin for 12 weeks | Drug | Rosuvastatin |
| Placebo100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks | Drug | Placebo |
Primary outcome
Stage of diabetic polyneuropathy
Time frame: 12 weeks
Severity of diabetic polyneuropathy
Time frame: 12 weeks
Severity according nerve conduction studies
Nerve conduction studies
Time frame: 12 weeks
Neuropathy symptoms and impairment scores
Time frame: 12 weeks
Lipid peroxidation
Time frame: 12 weeks
Nerve growth factor
Time frame: 12 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 20 Jun 2012.
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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.
Ernesto G. Cardona-Muñoz, MD, PhD study director
University of Guadalajara
Luis Miguel Roman-Pintos, MD,PhD study chair
University of Guadalajara
Rogelio Troyo-Sanroman, PhD 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 Rosuvastatin in people with Diabetic Polyneuropathy, run by Alejandra Guillermina Miranda Diaz 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 5 inclusion and 6 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 20 Jun 2012. 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?
Stage of diabetic polyneuropathy (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2012.