Status:
UNKNOWN
Anti-inflammatory Status in DM2 Treated Patients
Lead Sponsor:
University of Catanzaro
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- DMT2 patients were enrolled in presence of
- Age \>35 and \<75 years old
- Uncontrolled diabetes during treatment (glycosylated hemoglobin (HbA1c) \> 75 mmol/mol )
- Combined therapy at least by 6 months.
Exclusion
- HbA1c \< 75 mmol/mol (9%);
- 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;
- Estimated glomerular filtration rate (GFR) \<30 ml/min (according to MDRD formula)
- .Liver Failure
- Recent history of Heart stroke, systemic infections, dehydration, lactic acidosis
- Heart failure (NYHA I - IV)
- Active bladder cancer or history of bladder cancer
- macroscopic haematuria of unidentified nature
- hypersensitivity to drug used (metformin, alogliptin, pioglitazone)
- breastfeeding
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04392557
Start Date
July 1 2020
End Date
June 20 2021
Last Update
September 16 2020
Active Locations (1)
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1
ASP Catanzaro
Catanzaro, Italy, 88100