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Rationale: Cardiovascular complications in type 2 diabetes are the leading cause of morbidity and mortality associated with the disease. Endothelial dysfunction is regarded as an important factor in these vascular complications.
The introduction of glucagon-like peptide-1 (GLP-1) analogues and dipeptidyl peptidase IV (DPP-IV) inhibitors for the treatment of type 2 diabetes is of special interest because of possible influences on endothelial function. Numerous reports have shown that GLP-1 improves endothelial function.
Objective: To determine whether a four week treatment with vildagliptin compared to acarbose improves endothelial dysfunction in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vildagliptin treatment first, acarbose treatment second | Experimental |
| |
| acarbose treatment first, vildagliptin treatment second | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin + acarbose | Drug | 4 week treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of vildagliptin on inflammatory markers and adipokines | 8 weeks | |
| Effect of vildagliptin on fat cell morphology and gene expression | 8 weeks | |
| Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C.J. Tack, MD, PhD, Prof. of Diabetology | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Nijmegen | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24485397 | Derived | van Poppel PC, Gresnigt MS, Smits P, Netea MG, Tack CJ. The dipeptidyl peptidase-4 inhibitor vildagliptin does not affect ex vivo cytokine response and lymphocyte function in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2014 Mar;103(3):395-401. doi: 10.1016/j.diabres.2013.12.039. Epub 2014 Jan 3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| acarbose + vildagliptin |
| Drug |
4 week treatment |
|
| 8 weeks |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |