Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of Time in Range % at 7 days, at 1 and 6 months
研究概览
简要总结
The study aims to evaluate the effects of Insulin Degludec/Liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin Basal-bolus.
详细描述
100 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 2022 to April 2024. 50 patients were treated with Insulin Degludec/Liraglutide, 50 were undertaken treatment regime with Insulin Basal Bolus (control group).
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 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, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) 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, CRP, Ferritin, IL-6. These withdrawals were then repeated three months and six 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)
盲法说明
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
- 否
入选标准
- •Diabetes mellitus type 2
- •Mild-moderate Hyperglycemia (180-400 mg/dl)
- •Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)
排除标准
- •Diabetes mellitus type 1
- •Diabetic ketoacidosis
- •Hyperosmolar coma
- •Severe hypoglycaemia
- •Acute Pancreatitis
- •use of corticosteroids
- •pregnancy
- •Chronic kidney disease (< 30 ml/min) or hemodialysis
研究组 & 干预措施
patients treated with Insulin Degludec/Liraglutide
Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas.
干预措施: Insulin Degludec / Liraglutide Injectable Product (Drug)
patients treated with Insulin regime Basal Bolus
Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change of Time in Range % at 7 days, at 1 and 6 months
时间窗: 7 days, 1 months and 6 months
Evaluation of Time in Range % by continuous glycemic monitoring
Change of hypoglycemic events
时间窗: 7 days, 1 months and 6 months
Change of hypoglycemic events (symptoms and serum glycemia \< 60 mg/dl)
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
时间窗: 7 days, 1 months and 6 months
Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI \> 1,27)
次要结局
- Change from Baseline serum of C- Reactive-Protein (CRP)(7 days, 1 months and 6 months)
- Change from Baseline serum levels of Interleukin-6 (IL6)(7 days, 1 months and 6 months)
- Change from Baseline serum levels of ferritin(7 days, 1 months and 6 months)
- Change of intra and extra-hospital mortality(7 days, 1 months and 6 months)
研究者
Antonino Tuttolomondo
University professor
University of Palermo