Comparison of Anti-inflammatory Status Linked to Atherosclerosis Formation/Progression Among Diabetes Mellitus Type 2 Patients Under Combined Pharmacological Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- inflammatory miRNA
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
metformin/alogliptin
metformin/alogliptin (850 mg/12.5 mg or 1000 mg/12.5 mg every 12 hours) for 12 months
干预措施: Metformin / alogliptin Oral Product (Drug)
metformin/pioglitazone
metformin/pioglitazone (850 mg/15 mg every 12 hours) for 12 months
干预措施: Metformin / Pioglitazone Pill (Drug)
triple therapy
metformin/pioglitazone (850 mg/15 mg every 12 hours)+alogliptin (12.5 mg every 12 hours) for 12 months
干预措施: Metformin / alogliptin Oral Product (Drug)
triple therapy
metformin/pioglitazone (850 mg/15 mg every 12 hours)+alogliptin (12.5 mg every 12 hours) for 12 months
干预措施: Metformin / Pioglitazone Pill (Drug)
triple therapy
metformin/pioglitazone (850 mg/15 mg every 12 hours)+alogliptin (12.5 mg every 12 hours) for 12 months
干预措施: triple therapy (Drug)
结局指标
主要结局
inflammatory miRNA
时间窗: 12 months
Change from Baseline at 12 months
side effects
时间窗: 12 months
statistically significant difference (P\<0.05) in the development of side effects between the groups, recorded using the Naranjo adverse drug reactions scale
次要结局
- HbA1c levels(12 months)
- liver function(12 months)
- body weight(12 months)
- Waist values(12 months)
- drug interaction(12 months)
- Fasting blood glucose(12 months)
- cell count(12 months)
- lipid metabolism/atheroscelorisis(12 months)
研究者
Luca Gallelli
Principal investigator
University of Catanzaro