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

SDF-1 is an Important Cytokine for Neovascularization. Cleavage of SDF-1 is Reduced by DPPIV Inhibitors Clinical Trial

— FINNjA-DM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00936234
• Other study ID #: FINNjA-DM
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 2009
• Est. completion date: May 2013

Study information

• Verified date: August 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Neovascularization, Pathologic
• SDF-1 is an Important Cytokine for Neovascularization. Cleavage of SDF-1 is Reduced by DPPIV Inhibitors

Intervention

Drug:
• Vildagliptin
Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo

Locations

Country	Name	City	State
Germany	Department of Cardiology	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function		30 days
Secondary	Number and Function of Progenitor Cells		30 days