Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by the co-existence of renal failure.

One key aspect of chronic inflammatory diseases is the alteration in the polarization profile of circulating monocyte-macrophage cells.

Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which, in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic patients.

M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4 can affect the M1/M2 polarization balance.

In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin, compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without chronic renal failure.

In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the pathobiology of diabetic complications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Treatments: Linagliptin

Criteria

Inclusion Criteria:

• Type 2 diabetes

• eGFR > 60 mL/min/1.73 mq (for the patients without renal failure)

• eGFR 10-60 mL/min/1.73 mq (for the patients with renal failure)

Exclusion Criteria:

• Type 1 diabetes

• Hypersensitivity to Linagliptin or excipients

• Intolerance to other DPP-4 inhibitors

• Terminal renal failure (eGFR < 10 mL/min/1.73 mq)

• Use of GLP-1 analogs or other DPP-4 inhibitors

• Recent (within 1 month) trauma or surgery or acute diseases

• Any acute or chronic inflammatory condition

• Immunosuppression or organ transplantation

• Pregnancy or lactation

• Inability to provide informed consent.