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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00936234
First received: July 8, 2009
Last updated: June 21, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
SDF-1 is an Important Cytokine for Neovascularization. Cleavage of SDF-1 is Reduced by DPPIV Inhibitors
Drug: Vildagliptin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Functional Improvement of Progenitor Cells and Endothelial Function by Vildagliptin in Diabetes Mellitus (FINNjA-DM).

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number and Function of Progenitor Cells [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vildagliptin
starting with vildagliptin for 30 days followed by placebo for 30 days
Drug: Vildagliptin
Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo
Other Name: Galvus (R)
Placebo Comparator: Placebo
starting with placebo for 30 days followed by vildagliptin for 30 days
Drug: Vildagliptin
Vildagliptin, 50 mg twice a days, orally for 30 days followed by placebo
Other Name: Galvus (R)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936234

Contacts
Contact: Florian H Seeger, MD 0049 69 6301 7343 florian.seeger@kgu.de

Locations
Germany
Department of Cardiology Recruiting
Frankfurt, Germany, 60590
Contact: Florian H Seeger, MD    0049 69 6301 7343      
Sub-Investigator: Florian H Seeger, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Andreas M. Zeiher, MD Cardiology, University of Frankfurt
  More Information

No publications provided

Responsible Party: Prof. Dr. A.M. Zeiher, University of Frankfurt, Department of Cardiology
ClinicalTrials.gov Identifier: NCT00936234     History of Changes
Other Study ID Numbers: FINNjA-DM
Study First Received: July 8, 2009
Last Updated: June 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
CAD
diabetes
SDF-1
endothelial function

Additional relevant MeSH terms:
Diabetes Mellitus
Neovascularization, Pathologic
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metaplasia
Pathologic Processes
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014