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临床试验/NCT03824002
NCT03824002已完成4 期

Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study

University of Palermo1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年4月1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
92
试验地点
1
主要终点
Change from Baseline Reactive Hyperemia Index at 3 and 9 months

研究概览

简要总结

The study aims to evaluate arterial stiffness and endothelial function indexes and their relationship with clinic and laboratory varible in a group of diabetic patients in treatment with dulaglutide

详细描述

46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2017 to April 2018. For all patients treatment with dulaglutide was undertaken. As control group were recruited 46 patients from the same ward not affected by diabetes mellitus or affected by diabetes mellitus but not in treatment with dulaglutide.

The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.

Each patient treated with dulaglutide was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.

Among the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial hypertension and 26 (56.52%) hypercholesterolemia.

Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess the presence of microalbuminuria. These withdrawals were then repeated three months and nine months from the time of recruitment.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diabetes mellitus

排除标准

  • cancer, severe ckd, end stage liver disease

研究组 & 干预措施

patients treated with dulaglutide

Experimental

Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide

干预措施: Dulaglutide (Drug)

patients treated with dulaglutide

Experimental

Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide

干预措施: Aspart insulin (Drug)

patients treated with dulaglutide

Experimental

Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide

干预措施: Glargine (Drug)

patients treated with dulaglutide

Experimental

Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide

干预措施: Metformin (Drug)

patients treated with dulaglutide

Experimental

Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide

干预措施: Repaglinide (Drug)

patients not treated with dulaglutide

Active Comparator

Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide

干预措施: Aspart insulin (Drug)

patients not treated with dulaglutide

Active Comparator

Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide

干预措施: Glargine (Drug)

patients not treated with dulaglutide

Active Comparator

Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide

干预措施: Metformin (Drug)

patients not treated with dulaglutide

Active Comparator

Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide

干预措施: Repaglinide (Drug)

结局指标

主要结局

Change from Baseline Reactive Hyperemia Index at 3 and 9 months

时间窗: 0 months, 3 months and 9 months

Endothelial function index RHI

次要结局

  • Change from Baseline systolic blood pressure at 3 and 9 months(0 months, 3 months and 9 months)
  • Change from Baseline Body Mass Index at 3 and 9 months(0 months, 3 months and 9 months)
  • Change from Baseline cholesterol at 3 and 9 months(0 months, 3 months and 9 months)
  • Change from Baseline triglycerides at 3 and 9 months(0 months, 3 months and 9 months)
  • Change from Baseline glucose at 3 and 9 months(0 months, 3 months and 9 months)
  • Change from Baseline diastolic blood pressure at 3 and 9 months(0 months, 3 months and 9 months)
  • Change from Baseline Pulse Wave Velocity at 3 and 9 months(0 months, 3 months and 9 months)

研究者

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

Antonino Tuttolomondo

University professor

University of Palermo

研究点 (1)

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