Vildagliptin and Endothelium-dependent Vasodilatation

Radboud University Medical Center16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Endothelial Dysfunction

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose

Time frame: 8 weeks

Secondary Outcomes

Effect of vildagliptin on inflammatory markers and adipokines

Time frame: 8 weeks

Effect of vildagliptin on fat cell morphology and gene expression

Time frame: 8 weeks

Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli

Time frame: 8 weeks

Vildagliptin and Endothelium-dependent Vasodilatation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes