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临床试验/NCT07083232
NCT07083232已完成4 期

Comparative Study on the Effect of Sitagliptin, Pioglitazone and Dapagliflozine on Myocardial Infarction Induced Experimentally in Diabetic Rats

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
blood glucose

研究概览

简要总结

The aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.

详细描述

The American Diabetes Association defined diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction and failure of different organs, especially the eyes, kidneys, nerves, heart and blood vessels.

Myocardial ischemia represents a condition of sufferance for cardiomyocytes due to coronary blood flow reduction as compared to their metabolic needs, and it may exhibit through several clinical conditions.

People with type 2 diabetes mellitus are at increased risk of cardiovascular disease, heart failure and death, as compared with the general population. Studies show that the excess risks associated with diabetes mellitus are mediated primarily by hyperglycemia and overall poor risk factor control. Effective treatment of traditional cardiovascular risk factors has reduced the excess risk of atherosclerotic cardiovascular disease , such as acute myocardial infarction and stroke in people with type 2 diabetes mellitus.

In the last two decades, several studies have demonstrated reductions in the risk of cardiovascular outcomes and mortality in patients with type 2 diabetes mellitus with improved glucose and cholesterol-lowering therapies. Nevertheless, macrovascular disease remains the most common cause of death in type 2 diabetes mellitus patients and new diabetes therapies are highly desired, especially if they can offer cardiovascular benefits.

Sitagliptin is a potent and highly selective dipeptidyl peptidase-4 competitive inhibitor that does not affect the closely related enzymes dipeptidyl peptidase-8 or dipeptidyl peptidase-9 at therapeutic concentrations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • 50 adult male albino rats obtained from (Experimental Animal Breeding Farm, assuit -Cairo) weighing between 150- 200 g (at the beginning of the study)

排除标准

  • Female rats --Weight >200g

研究组 & 干预措施

standard normal diet and water group

Placebo Comparator

Group I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs.

干预措施: standard normal diet (Dietary Supplement)

low dose Streptozotocin group

Experimental

Group II: Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.)

干预措施: low dose Streptozotocin (Drug)

Sitagliptin group

Experimental

Group III: Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks

干预措施: Sitagliptin (Novartis, USA) (Drug)

Pioglitazone group

Experimental

Group IV : Pioglitazone treated diabetic group ; Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks

干预措施: Pioglitazone hydrochloride (Unipharma., Egypt) (Drug)

Dapagliflozine group

Experimental

Group V : Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks

干预措施: Dapagliflozine hemihydrate (Janssen, USA) (Drug)

结局指标

主要结局

blood glucose

时间窗: one week

次要结局

  • tumor necrosis factor-α(One week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

El Shazly Abdelaal Mohaseb

Assistant lecturer of pharmacology

Al-Azhar University

研究点 (1)

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