Anti-inflammatory Status in DM2 Treated Patients

Diabetes Mellitus, Type 2 Clinical Trial

— INF-DM2-Ther  

Official title:

Comparison of Anti-inflammatory Status Linked to Atherosclerosis Formation/Progression Among Diabetes Mellitus Type 2 Patients Under Combined Pharmacological Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04392557
• Other study ID #: Inflammation-DM2
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: September 2020
• Source: University of Catanzaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 20, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin / alogliptin Oral Product
850 or 1000 mg/ 12.5 mg every 12 hours for 12 months
• Metformin / Pioglitazone Pill
(850 mg/15 mg every 12 hours) for 12 months
• triple therapy
Metformin / Alogliptin/ Pioglitazone

Locations

Country	Name	City	State
Italy	ASP Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory miRNA	Change from Baseline at 12 months	12 months
Primary	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	12 months
Secondary	body weight	effects of each treatment on body mass index (kg/m^2) (as indirect indexes of systemic inflammation and visceral adiposity).	12 months
Secondary	Waist values	effects of each treatment on waist values (cm) (as indirect indexes of systemic inflammation and visceral adiposity).	12 months
Secondary	drug interaction	statistically significant difference (P<0.05) in the development of drug-drug interactions, recorded using the DIPS scale	12 months
Secondary	Fasting blood glucose	effects of each treatment on fasting blood glucose (mg/dL) (as indexes of glucose metabolism);	12 months
Secondary	HbA1c levels	effects of each treatment on HbA1c levels (percent) (as indexes of glucose metabolism);	12 months
Secondary	liver function	alanine aminotransferase, aspartate aminotransferase, gamma glutamyl-transpeptidase levels, and total bilirubin levels (expressed as mg/dL) (as indexes of liver function).	12 months
Secondary	cell count	effects of each treatment on white blood cell count expressed as cell/mm3 (as direct index of systemic inflammation)	12 months
Secondary	lipid metabolism/atheroscelorisis	total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides levels (expressed as mg/dL) (as direct indexes of lipid metabolism and atheroscelorisis).	12 months