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Bone Marrow Progenitor Cell Mobilization in Diabetes

NCT01102699 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-09-02

No results posted yet for this study

Summary

Diabetes mellitus is associated with a significant reduction of circulating progenitor cells (CPCs). These include endothelial progenitor cells (EPCs), which are involved in cardiovascular homeostasis and repair. A reduction of CPCs in metabolic patients is associated with an increased risk of future adverse cardiovascular outcomes. Therefore, ways to active stimulate an increase of CPC levels in diabetes are actively pursued.

Experimental animal studies and preliminary data in humans indicate that a bone marrow defect is causally related to the low CPC level in diabetes.

Our previous data in rats indicate that diabetes reduces the bone marrow responsiveness to granulocyte colony-stimulating factor (G-CSF) in terms of progenitor cell mobilization.

In the present study, we aim at investigating bone marrow responsiveness to pharmacological mobilization of CPC in diabetic patients as compared to non-diabetic subjects.

Conditions

Interventions

DRUG

Filgrastim, hrG-CSF

Single subcutaneous injection of Filgrastim (hrG-CSF) 300 microg (30 MU)

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Angelo Avogaro, MD PhD · Dept. of Medicine, University of Padova, Medical School, Padova (Italy)

  • Gian Paolo Fadini, MD · Department of Medicine, University of Padova.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01102699 on ClinicalTrials.gov