Vascular Inflammation Clinical Trial
Official title:
Linagliptin as a Modulator of Vascular Inflammation in Patients With Type 2 Diabetes Mellitus
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.
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