Effect of the Weekly Administration of Exenatide LAR or Dulaglutide on the Variability of Blood Pressure and Heart Rate of 24 Hours in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment.
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diastolic blood pressure, daytime, night and 24 h
研究概览
简要总结
Mortality due to cardiovascular problems is increased by having Diabetes Mellitus type 2 (DM2), related to the time of evolution and glucose levels or if alterations in blood pressure coexist. With this variability there is greater damage to the target organ and in patients with DM2 the process is more severe and frequent due to alterations in the coagulation mechanisms that accelerate in the presence of hypertension, figures ≥135 / 85 mmHg are considered risk factors to develop coronary, cerebral or renal events. As a quantitative range, blood pressure is currently monitored ambulatory by (MAP) which is the most used and reliable non-invasive instrument for its evaluation. The American Association of Clinical Endocrinologists (AACE) proposes an algorithm that contemplates initiating management to patients with a diagnosis of diabetes with drugs such as metformin, thiazolidinediones and glucagon-like peptide analogues type 1 (GLP1).
Exenatide LAR and Dulaglutide are GLP-1 analogue drugs with potential to decrease the progressive losses of pancreatic β cell function and mass and cardiovascular risk (CV) factors with maintained use, in addition to hypoglycemic, hypotensive effects, weight decreases and visceral adiposity, however, it has been reported that although they share the same basic mechanism of action, each one has a different molecular structure and pharmacokinetic profile that make their pharmacological and clinical effects different, in particular as regards the variability of blood pressure and heart rate.
详细描述
A randomized, open clinical trial of 30 patients with a diagnosis of diabetes in accordance with the American Diabetes Association (ADA) without treatment.
They will be assigned randomly in two groups of 15 patients each to receive 2 mg subcutaneous of Exenatide LAR (Bydureon by Astra Zeneca) or Dulaglutide .75 mg (trulicity, by Lilly), once weekly before breakfast during 4 weeks.
There will be calculated body mass index (BMI); low-density lipoprotein cholesterol (LDL-c); very-low density lipoprotein (VLDL), glomerular filtration rate and blood pressure variability. This protocol it's already approved by the local ethics committee with number CEI/447/2017 and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency, dispersion, average and deviation standard for quantitative variables, frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
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
- None
入排标准
- 年龄范围
- 31 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients both sexes
- •Age between 31 and 60 years
- •Diagnosis of diabetes according ADA criteria:
- •(Fasting blood glucose levels >125 mg/dl or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose > 200 mg/dl, or glycosylated hemoglobin >6.5%).
- •Informed consent signed
排除标准
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Hypersensibility to ingredients of intervention
- •Physical impossibility for apply the drug
- •Known pancreatic, renal, hepatic, heart or thyroid diseased
- •Hypertension diagnosis
- •Previous treatment for glucose
- •Body Mass Index ≥39.9 kg/m2
- •Triglycerides ≥500 mg/dL
- •Total cholesterol ≥300 mg/dL
- •Night or rotating shift workers
- •Blood Pressure ≥140/90 mmHg
研究组 & 干预措施
Drug: Exenatide LAR
Exenatide LAR 2 mg, once weekly subcutaneously before breakfast during 4 weeks.
干预措施: Exenatide LAR (Drug)
Drug: Dulaglutide
Dulaglutide .75 mg, once weekly subcutaneously Before breakfast during 4 weeks.
干预措施: Dulaglutide (Drug)
结局指标
主要结局
Diastolic blood pressure, daytime, night and 24 h
时间窗: Baseline to Week 4
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3
Heart rate: nighttime, daytime and 24-h
时间窗: Baseline to Week 4
heart rate variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O3
Systolic blood pressure, daytime, night and 24 h
时间窗: Baseline to Week 4
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 h by oscillometric method Microlife WatchBP O33.
Blood pressure
时间窗: Baseline to Week 4
Blood pressure will be measured at baseline and week 4 with a digital sphygmomanometer and the entered values reflect the blood pressure.
次要结局
- Central and peripheral blood pressure(Baseline to Week 4)
- Body Weight(Baseline to Week 4)
- Pulse wave velocity(Baseline to Week 4)
- Cardio-ankle Vascular Index (CAVI)(Baseline to Week 4)
- Categories: dipper o non dipper(Baseline to Week 4)
- Fasting glucose levels(Baseline to Week 4)
- Glycosylated hemoglobin(Baseline to Week 4)
- Body Mass Index(Baseline to Week 4)
- Total cholesterol(Baseline to Week 4)
- Triglycerides levels(Baseline to Week 4)
- High density lipoprotein (c-HDL) levels(Baseline to Week 4)
- Alanine aminotransferase (ALT) levels(Baseline to Week 4)
- Aspartate aminotransferase (AST) levels(Baseline to Week 4)
- Creatinine levels(Baseline to Week 4)
- Uric acid levels(Baseline to Week 4)
- Waist Circumference(Baseline, week 4)
研究者
Manuel González Ortiz
PhD
University of Guadalajara