NCT01600690

Brief Summary

Statins are commonly prescribed to lower cardiovascular risk in primary and secondary prevention. Despite their well known efficacy, statin withdrawal is a common event. Even a short term statin withdrawal can have dramatic consequences on atherosclerotic plaque stability, owing to a rebound in cholesterol levels and inflammation. The effects of a short term statin withdrawal on endothelial progenitor cells (EPC) and monocyte/macrophage polarization is unknown. In this study, the investigators will explore the effects of a 5-day statin withdrawal on EPC and monocyte/macrophage polarization, together with other inflammatory biomarkers in type 2 diabetic patients. The investigators hypothesize that statin withdrawal determines a reduction in EPC levels and an inflammatory cell polarization. Patients will be randomized to continue their habitual statin regimen or to withdraw statin. At baseline and 5 days later, blood samples will be collected for experimental measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started May 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

May 15, 2012

Last Update Submit

August 12, 2013

Conditions

Type 2 Diabetes MellitusAtherosclerosisDyslipidemia

Keywords

Stem cellsRegenerationInflammation

Outcome Measures

Primary Outcomes (1)

  • Change in EPC levels

    Change in EPC levels at day 5 versus baseline will be compared between patients who continued taking statins and patients who withdrawed

    5 days

Secondary Outcomes (2)

  • Change in M1/M2 polarization

    5 days

  • Change in hsCRP

    5 days

Study Arms (2)

Continue statin regimen

NO INTERVENTION

Patients randomized to this arm will continue their usual statin regimen and dose, without any intervention.

Statin withdrawal

EXPERIMENTAL

Patients randomized to this arm will stop statin treatment for 5 days.

Other: Statin withdrawal

Interventions

Statin withdrawalOTHER

Patients are instructed to stop taking statin pills for the duration of the study. The rest of therapy will remain unchanged.

Statin withdrawal

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes mellitus
  • Age 35-80
  • Males and Females
  • eGFR\>30 ml/min/1.73 mq
  • On statin therapy from at least 6 months
  • Minimal statin dosage: Simvastatin 10 mg; Pravastatin 40 mg; Fluvastatin 80 mg; Rosuvastatin 5 mg; Atorvastatin 10 mg.

You may not qualify if:

  • Type 1 diabetes mellitus
  • Age \<35 or \>80
  • Chronic renal failure (eGFR\<30 ml/min/1.73 mq)
  • Recent (within 1 month) acute diseases or trauma or surgery
  • Chronic inflammatory diseases (e.g. rheumatoid arthritis)
  • Active cancer
  • LDL cholesterol \> 160 mg/dL
  • Carotid atherosclerosis (\>30% stenosis), coronary artery disease, peripheral arterial disease (Leriche stages II-IV)
  • On ezetimibe, fibrates, or niacin
  • Therapy with EP hormones
  • Pregnancy or lactation
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Diabetes Outpatient Clinic

Padua, 35100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2AtherosclerosisDyslipidemiasInflammation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gian Paolo Fadini, M.D.

    University of Padova

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 17, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

IT(1)