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
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
- 是
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
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
干预措施: Dulaglutide (Drug)
patients treated with dulaglutide
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
干预措施: Aspart insulin (Drug)
patients treated with dulaglutide
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
干预措施: Glargine (Drug)
patients treated with dulaglutide
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
干预措施: Metformin (Drug)
patients treated with dulaglutide
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
干预措施: Repaglinide (Drug)
patients not treated with dulaglutide
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
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
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
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
Antonino Tuttolomondo
University professor
University of Palermo
