Effect of Sitagliptin on Endothelial Progenitor Cells
Effects of 4-week Sitagliptin Therapy on Endothelial Progenitor Cells in Type 2 Diabetic Patients. A Non-randomized Controlled Open-label Pilot Trial.
1 other identifier
interventional
40
1 country
1
Brief Summary
Endothelial progenitor cells (EPCs) are involved in cardiovascular homeostasis, through angiogenesis and endothelial healing. Diabetic patients have a high risk of cardiovascular events and low levels of circulating EPCs. Sitagliptin is an oral DPP-IV antagonist, approved for the treatment of type 2 diabetes. It increases the bioavailability of endogenous incretins, thus improving insulin and glucagon secretion. SDF-1, one of the major EPC regulators, is also a substrate of DPP-IV. This study tests the hypothesis that sitagliptin increases the levels of circulating EPCs in type 2 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes-mellitus
Started Oct 2009
Shorter than P25 for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2009
CompletedFirst Posted
Study publicly available on registry
August 28, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedApril 5, 2010
April 1, 2010
3 months
August 26, 2009
April 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in circulating CD34+KDR+ endothelial progenitor cells
4 weeks
Secondary Outcomes (1)
Change in SDF-1alpha concentrations
4 weeks
Study Arms (2)
Treatment
EXPERIMENTALSitagliptin 100 mg once daily for 4 weeks
Control
NO INTERVENTIONNo change in anti-diabetic treatment regimen for at least 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes;
- Both genders
- Age 40-80
- fasting c-peptide \>=1.0 ng/L
- Therapy with metformin or sulphonylureas
- HbA1c \>7.0%
- No contraindications to sitagliptin use
You may not qualify if:
- Type 1 diabetes
- Age \<40 or \>80
- fasting c-peptide \<1.0 ng/L
- Therapy with TZD
- HbA1c \<=7.0%
- Acute concomitant diseases
- Immunological disorders
- Recent (within 3 months) cardiovascular events or surgery
- Pregnancy and lactation
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Padova, Medical School
Padua, 35100, Italy
Related Publications (1)
Fadini GP, Boscaro E, Albiero M, Menegazzo L, Frison V, de Kreutzenberg S, Agostini C, Tiengo A, Avogaro A. The oral dipeptidyl peptidase-4 inhibitor sitagliptin increases circulating endothelial progenitor cells in patients with type 2 diabetes: possible role of stromal-derived factor-1alpha. Diabetes Care. 2010 Jul;33(7):1607-9. doi: 10.2337/dc10-0187. Epub 2010 Mar 31.
PMID: 20357375RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angelo Avogaro, MD PhD
Dept. Clinical and Experimental Medicine, University of Padova, Medical School, Padova (Italy)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 26, 2009
First Posted
August 28, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
April 5, 2010
Record last verified: 2010-04