NCT01622777

Brief Summary

To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

June 15, 2012

Last Update Submit

June 18, 2012

Conditions

Diabetic Polyneuropathy

Keywords

RosuvastatinDiabetic polyneuropathyNerve conductionOxidative stressNerve growth factor

Outcome Measures

Primary Outcomes (6)

  • Stage of diabetic polyneuropathy

    12 weeks

  • Severity of diabetic polyneuropathy

    Severity according nerve conduction studies

    12 weeks

  • Nerve conduction studies

    12 weeks

  • Neuropathy symptoms and impairment scores

    12 weeks

  • Lipid peroxidation

    12 weeks

  • Nerve growth factor

    12 weeks

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

20 mg daily of oral rosuvastatin

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RosuvastatinDRUG

20 mg daily of oral rosuvastatin for 12 weeks

Rosuvastatin
PlaceboDRUG

100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks

Placebo

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Research Unit. University of Guadalajara.

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Diabetic NeuropathiesHereditary Sensory and Autonomic Neuropathies

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesNervous System MalformationsHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ernesto G. Cardona-Muñoz, MD, PhD

    University of Guadalajara

    STUDY DIRECTOR

  • Luis Miguel Roman-Pintos, MD,PhD

    University of Guadalajara

    STUDY CHAIR

  • Rogelio Troyo-Sanroman, PhD

    University of Guadalajara

    STUDY CHAIR

  • María del Pilar Alatorre-Carranza, PhD

    Hospital Civil de Guadalajara

    STUDY CHAIR

  • Alejandra G. Miranda-Diaz, MD, PhD

    University of Guadalajara

    STUDY DIRECTOR

  • Jaime Hernandez-Ojeda, MD, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator of Cardiovascular Research Unit

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

ME(1)