Clinical trial NCT04392557: Anti-inflammatory Status in DM2 Treated Patients
Official title: Comparison of Anti-inflammatory Status Linked to Atherosclerosis Formation/Progression Among Diabetes Mellitus Type 2 Patients Under Combined Pharmacological Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center single blind study
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* DMT2 patients were enrolled in presence of

  1. Age \>35 and \<75 years old
  2. Uncontrolled diabetes during treatment (glycosylated hemoglobin (HbA1c) \> 75 mmol/mol )
  3. Combined therapy at least by 6 months.

Exclusion Criteria:

1. HbA1c \< 75 mmol/mol (9%);
2. History of drug abuse or alcohol abuse, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1 drink per day: 7 drinks per week) in the previous one year;
3. Estimated glomerular filtration rate (GFR) \<30 ml/min (according to MDRD formula)
4. .Liver Failure
5. Recent history of Heart stroke, systemic infections, dehydration, lactic acidosis
6. Heart failure (NYHA I - IV)
7. Active bladder cancer or history of bladder cancer
8. macroscopic haematuria of unidentified nature
9. hypersensitivity to drug used (metformin, alogliptin, pioglitazone)
10. breastfeeding

Primary outcomes:
measure: inflammatory miRNA
timeFrame: 12 months
measure: side effects
timeFrame: 12 months
Secondary outcomes:
measure: body weight
timeFrame: 12 months
measure: Waist values
timeFrame: 12 months
measure: drug interaction
timeFrame: 12 months
measure: Fasting blood glucose
timeFrame: 12 months
measure: HbA1c levels
timeFrame: 12 months
measure: liver function
timeFrame: 12 months
measure: cell count
timeFrame: 12 months
measure: lipid metabolism/atheroscelorisis
timeFrame: 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: ASP Catanzaro
Study officials:
References: