Examination of the effect of Linagliptin versus placebo for 6 months on vascular inflammation of the carotic artery and on abdominal adipose tissue inflammation in patients with diabetes mellitus type 2. The effect will be assessed by FDG-PET scan. Furthermore the effect of Linagliptin on the vessel wall volume of the carotid artery will be assessed by MRI scan and biomarkers of vascular inflammation will be analyzed in blood samples.
As part of the screening a PET-CT scan is executed to examine baseline vascular inflammation of the carotid artery and to evaluate abdominal adipose tissues inflammation. Patients who are eligible to participate in the study according to the in- and exclusion criteria will be randomised in one of the two study arms. According to the randomisation the patients will receive 5 mg Linagliptin or placebo per day for a period of 6 months. To evaluate the effect of Linagliptin versus placebo the vessel wall volume of the artery will be assessed by MRI scan and the vascular inflammation of the carotid artery by FDG-PET, furthermore the vascular inflammation will be analyzed by biomarkers in blood samples and the abdominal adipose tissue inflammation will investigated by subcutaneous adipose tissue biopsies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
Department of Internal Medicine I, University Hospital
Aachen, Germany
Cardiovascular Research Institute Maastricht (CARIM)
Maastricht, Netherlands
Effect of linagliptin on vascular inflammation of the carotic artery
Examination of the effect of 5 mg linagliptin qd versus placebo on vascular inflammation of the carotic artery by FDG-PET in patients with diabetes mellitus within 6 months.
Time frame: up to 6 months
Effect of linagliptin on vessel wall volume of the carotid artery
Examination of the effect of 5mg linagliptin qd versus placebo on vessel wall volume of the carotid artery by MRI scan.
Time frame: baseline and 6 months
Effect of linagliptin on abdominal adipose tissue inflammation
Evaluation of the effect of 5mg linagliptin qd versus placebo on abdominal adipose tissue inflammation by FDG-PET in addition to adipose tissue biopsies.
Time frame: baseline and 6 months
Effect of linagliptin on biomarkers of vascular inflammation
Blood analysis to examine the effect of linagliptin on biomarkers of vascular inflammation.
Time frame: baseline and 6 months
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