Endothelial Dysfunction, Type 2 Diabetes
Conditions
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.
Interventions
DRUGvildagliptin + acarbose
4 week treatment
DRUGacarbose + vildagliptin
4 week treatment
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 8 weeks |
Countries
Netherlands
Outcome results
None listed