Vascular Effects of Sitagliptin in Diabetes Mellitus
Study Details
Study Description
Brief Summary
Glucagon-like peptide 1 (GLP-1) is a 30-amino acid gut hormone secreted in a nutrient-dependent manner that stimulates insulin secretion and inhibits glucagon secretion and gastric emptying, thereby reducing postprandial glycemia.1,2 GLP-1 is derived from posttranslational proteolysis of preproglucagon, and its peptide sequence is identical in mouse, rat, and human.2,3 After secretion from enteroendocrine L cells, GLP-1(7-36) amide is rapidly degraded by dipeptidyl peptidase-4 (DPP-4) to its N-terminally truncated metabolite GLP-1(9-36), which does not interact with the known GLP-1 receptor.4,5 The diverse actions of GLP-1 include the proliferation, differentiation, and protection from apoptosis of pancreatic β cells and the induction of satiety. GLP-1 also improves memory and learning, stimulates afferent sensory nerves, and has neuroprotective functions.1,6 Furthermore, GLP-1 receptor agonists have been reported to have cardiac and vascular actions in rodents and humans that include effects on contractility, blood pressure, cardiac output,7-10 and cardioprotection.11-14
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The aim of this study is to evaluate the effect of a therapy with the DPP-4-inhibitor sitagliptin on the prognostic relevant endothelial function and endothelial progenitor cells in patients with type 2 diabetes mellitus.
Primary endpoint: Endothelium-dependent vasodilation before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor Sitagliptin and placebo treatment respectively.
Secondary endpoint: effect of sitagliptin on mobilization, NO-production and in vivo regenerative capacity of human endothelial progenitor cells before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sitagliptin 100 mg sitagliptin per day for 2 weeks |
Drug: Sitagliptin
oral tablets 100 mg per day for two weeks
|
| Placebo Comparator: Placebo 1 placebo tablet per day for 2 weeks |
Drug: Placebo
oral tablet, one per day for two weeks
|
| No Intervention: Healthy Control Healthy control subjects |
Other: Control
no intervention
|
Outcome Measures
Primary Outcome Measures
- Endothelial function [Before and after two week treatment]
Effect of sitagliptin on endothelium-dependent vasodilation before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively
Secondary Outcome Measures
- Effect on EPCs [Before and after two week treatment]
Effect of sitagliptin on mobilization, NO-production and in vivo regenerative capacity of human endothelial progenitor cells before and after treatment of patients with type 2 diabetes mellitus with the DPP-4-inhibitor sitagliptin and placebo treatment respectively
Eligibility Criteria
Criteria
Inclusion Criteria:
- Type 2 Diabetes mellitus
Exclusion Criteria:
-
Allergy to sitagliptin
-
Treatment with PPAR-gamma agonist
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hannover Medical School | Hannover | Germany | 30625 |
Sponsors and Collaborators
- Hannover Medical School
Investigators
- Principal Investigator: Sajoscha A. Sorrentino, M.D., Hannover Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MHH_NPH_SS_1/2010
- MHH_NPH_SS_1/2010