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Functional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus (FINNjA-DM). (FINNjA-DM)

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ClinicalTrials.gov Identifier: NCT00936234
Recruitment Status : Unknown
Verified July 2009 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : July 9, 2009
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

July 8, 2009
July 9, 2009
June 22, 2011
July 2009
September 2011   (Final data collection date for primary outcome measure)
Endothelial Function [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT00936234 on ClinicalTrials.gov Archive Site
Number and Function of Progenitor Cells [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
 
Functional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus (FINNjA-DM).
Functional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus (FINNjA-DM).

SDF-1, an important cytokine for neovascularisation is cleaved by (dipeptidyl peptidase IV) DPPIV.

The aim of this study is to assess the effect of the dipeptidyl peptidase IV inhibitor vildagliptin (Galvus®) on endothelial function as well as number and functional activity of progenitor cells in patients with documented diabetes mellitus.

The peptidase CD26 (DPPIV/dipeptidyl peptidase IV) removes dipeptides from the amino terminus of proteins and thereby inactivates these cleaved proteins. It was shown, that CD26 cleaves SDF-1 into a non-mitogenic molecule. Inhibition or deletion of CD26 leads to an increased homing of hematopoietic progenitor cells to the bone marrow after transplantation by increasing the invasion capacity of these cells {Campbell et al. 2008; Christopherson et al. 2004}.

The cytokine SDF-1 is released in response to hypoxia, is crucial for progenitor cell homing and recruitment of cells for neovascularisation. Invasion capacity is closely related to the cytokine SDF-1 and the SDF-1 receptor CXCR4 {Ceradini et al. 2004}. The in vivo neovascularisation capacity of progenitor cells is closely correlated to their functional capacity as SDF-1 induced invasion or colony-forming capacity {Heeschen et al. 2004; Britten et al. 2003; Assmus et al. 2007}.

Therefore, the aim of this study is to assess the effect of the dipeptidyl peptidase IV inhibitor vildagliptin on endothelial function as well as number and functional activity of progenitor cells in patients with documented diabetes mellitus.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
SDF-1 is an Important Cytokine for Neovascularization. Cleavage of SDF-1 is Reduced by DPPIV Inhibitors
Drug: Vildagliptin
Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo
Other Name: Galvus (R)
  • Active Comparator: Vildagliptin
    starting with vildagliptin for 30 days followed by placebo for 30 days
    Intervention: Drug: Vildagliptin
  • Placebo Comparator: Placebo
    starting with placebo for 30 days followed by vildagliptin for 30 days
    Intervention: Drug: Vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
November 2012
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with diabetes mellitus type 2 under stable medication
  • HbA1c between 7% an 10%
  • age between 18 and 80 years
  • signed informed consent

Exclusion Criteria:

  • Atrial fibrillation (plethysmographic recordings can only obtained in sinus-rhythm)
  • CAD with reduced left ventricular ejection fraction (LVEF <45%)
  • Pregnancy, chronic or acute infection, fever
  • Diabetes mellitus type 1
  • Newly diagnosed diabetes, uncontrolled diabetes
  • Neoplasm
  • Known allergy to study drug
  • Severe liver/kidney disease
  • HIV, Hepatitis
  • Participation at other studies within the last 30 days
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00936234
FINNjA-DM
Yes
Not Provided
Not Provided
Prof. Dr. A.M. Zeiher, University of Frankfurt, Department of Cardiology
Johann Wolfgang Goethe University Hospital
Not Provided
Principal Investigator: Andreas M. Zeiher, MD Cardiology, University of Frankfurt
Johann Wolfgang Goethe University Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP