Clinical trial NCT01000688: Vildagliptin and Endothelium-dependent Vasodilatation
Official title: The Effect of Vildagliptin on Endothelium-dependent Vasodilatation. A Double Blind Cross-over Study in Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Endothelial Dysfunction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 16
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Age 35-75 years
* Treatment with metformin monotherapy or metformin combination therapy
* HbA1c \<8.0%

Exclusion Criteria:

* Renal disease defined as creatinine level \> 130 umol/l
* Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
* Current use of acetylsalicylic acid or vitamine K antagonists
* History of smoking within the past year
* History of or current abuse of drugs or alcohol
* History of heartfailure (NYHA class III or IV)
* Abnormalities on ECG that might interfere with current study protocol
* Pregnancy or breastfeeding
* Inability to understand the nature and extent of the trial and procedures required
* Presence of any medical condition that might interfere with the current study protocol
* Participation in a drug trial within 60 days prior to the first dose

Primary outcomes:
measure: Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of vildagliptin on inflammatory markers and adipokines
timeFrame: 8 weeks
measure: Effect of vildagliptin on fat cell morphology and gene expression
timeFrame: 8 weeks
measure: Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: C.J. Tack, MD, PhD, Prof. of Diabetology
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.