NCT01102699

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_4 diabetes-mellitus

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

First Submitted

Initial submission to the registry

April 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3.2 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

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

3.2 years

First QC Date

April 9, 2010

Last Update Submit

August 30, 2013

Conditions

Diabetes Mellitus

Keywords

Diabetesstem cellsbone marrowmobilization

Outcome Measures

Primary Outcomes (1)

  • CPC mobilization after a single G-CSF dose

    Circulating progenitor cell level will be assessed before and 24 hours after a single G-CSF dose in both diabetic and non diabetic patients. Change in CPC level will be indicative of bone marrow mobilization. Mobilization will be compared in diabetic versus non diabetic subjects.

    0-24 hours

Study Arms (1)

Filgrastim, G-CSF

EXPERIMENTAL

Single s.c. dose of G-CSF (300 microg)

Drug: Filgrastim, hrG-CSF

Interventions

Filgrastim, hrG-CSFDRUG

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

Filgrastim, G-CSF

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus (for cases) or absence of diabetes (for controls);
  • Age 25-65;
  • Both sexes;
  • Capability of providing informed consent.

You may not qualify if:

  • Age \<25 or \>65;
  • Fertile women;
  • Recent (within 2 months) acute illnesses;
  • Chronic immune of infectious diseases;
  • Current or remote hematological disorders;
  • Leukocytosis, leukopenia or thrombocytopenia;
  • Organ transplantation or immune suppression;
  • Altered liver function;
  • Severe renal failure (eGFR\<30 mL/min/m2);
  • Anomalies in lymphocytes subpopulations;
  • High basal level of CD34+ cell count;
  • Allergy to Filgrastim;
  • Bronchial asthma or other chronic lung disorders;
  • Current or remote cancer;
  • Deny or impossibility to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Division of Metabolic Diseases

Padua, 35100, Italy

Location

Related Publications (1)

  • Fadini GP, Albiero M, Vigili de Kreutzenberg S, Boscaro E, Cappellari R, Marescotti M, Poncina N, Agostini C, Avogaro A. Diabetes impairs stem cell and proangiogenic cell mobilization in humans. Diabetes Care. 2013 Apr;36(4):943-9. doi: 10.2337/dc12-1084. Epub 2012 Oct 30.

    PMID: 23111057DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Angelo Avogaro, MD PhD

    Dept. of Medicine, University of Padova, Medical School, Padova (Italy)

    PRINCIPAL INVESTIGATOR

  • Gian Paolo Fadini, MD

    Department of Medicine, University of Padova.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 13, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations

IT(1)