Diabetes mellitus Type 2 (DMT2) - a progressive insulin secretory defect on the background of insulin resistance - is one of the major risk factors for atherosclerosis, an inflammatory disease of the arterial wall, in which leukocytes and oxidized lipoproteins accumulate leading to formation of fatty streaks and atherosclerotic plaques. Atherosclerosis accounts for more than 600,000 deaths annually in the U.S. mainly due to acute myocardial infarction and stroke. Pharmacological therapy of DMT2 includes several drugs used as monotherapy, although combination therapy between metfomin plus thiazolidinediones (TZD) and/or dipeptidyl-peptidase 4 inhibitors (DPP4I) plus TDZ, may delay atherosclerosis progression even if the molecular mechanisms are not clear. Even if normoglycemia is achieved, DMT2 patients still displayed a higher risk for developing atherosclerosis suggesting that other mechanisms of the inflammatory status are involved
Diabetes mellitus Type 2 (DMT2) - a progressive insulin secretory defect on the background of insulin resistance - is one of the major risk factors for atherosclerosis, an inflammatory disease of the arterial wall, in which leukocytes and oxidized lipoproteins accumulate leading to formation of fatty streaks and atherosclerotic plaques. Atherosclerosis accounts for more than 600,000 deaths annually in the U.S. mainly due to acute myocardial infarction and stroke. Pharmacological therapy of DMT2 includes several drugs used as monotherapy, although combination therapy between metfomin plus thiazolidinediones (TZD) and/or dipeptidyl-peptidase 4 inhibitors (DPP4I) plus TDZ, may delay atherosclerosis progression even if the molecular mechanisms are not clear . Even if normoglycemia is achieved, DMT2 patients still displayed a higher risk for developing atherosclerosis suggesting that other mechanisms of the inflammatory status are involved
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
850 or 1000 mg/ 12.5 mg every 12 hours for 12 months
(850 mg/15 mg every 12 hours) for 12 months
Metformin / Alogliptin/ Pioglitazone
ASP Catanzaro
Catanzaro, Italy
RECRUITINGinflammatory miRNA
Change from Baseline at 12 months
Time frame: 12 months
side effects
statistically significant difference (P\<0.05) in the development of side effects between the groups, recorded using the Naranjo adverse drug reactions scale
Time frame: 12 months
body weight
effects of each treatment on body mass index (kg/m\^2) (as indirect indexes of systemic inflammation and visceral adiposity).
Time frame: 12 months
Waist values
effects of each treatment on waist values (cm) (as indirect indexes of systemic inflammation and visceral adiposity).
Time frame: 12 months
drug interaction
statistically significant difference (P\<0.05) in the development of drug-drug interactions, recorded using the DIPS scale
Time frame: 12 months
Fasting blood glucose
effects of each treatment on fasting blood glucose (mg/dL) (as indexes of glucose metabolism);
Time frame: 12 months
HbA1c levels
effects of each treatment on HbA1c levels (percent) (as indexes of glucose metabolism);
Time frame: 12 months
liver function
alanine aminotransferase, aspartate aminotransferase, gamma glutamyl-transpeptidase levels, and total bilirubin levels (expressed as mg/dL) (as indexes of liver function).
Time frame: 12 months
cell count
effects of each treatment on white blood cell count expressed as cell/mm3 (as direct index of systemic inflammation)
Time frame: 12 months
lipid metabolism/atheroscelorisis
total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides levels (expressed as mg/dL) (as direct indexes of lipid metabolism and atheroscelorisis).
Time frame: 12 months
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