Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in ambulatory blood pressure
研究概览
简要总结
Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential. The time course and the mechanism behind this effect are unknown.
Objectives: To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes
Design: Open-label study with intervention and subsequent washout period
Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2 diabetes.
Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once daily for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide treatment.
Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV
详细描述
Hypotheses Primary hypothesis • Liraglutide treatment causes a reduction in 24h BP
Secondary hypothesis:
- The effect on BP may be mediated by an increase in natriuresis, thereby affecting ECV
- The effect on BP may be mediated by a decrease in arterial stiffness and central aortic pressure
Purpose Primary purpose
• To assess how quickly the antihypertensive effect of liraglutide treatment set in after initiation in patients with type 2 diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee
- •Male or female patients > 18 years with type 2 diabetes (WHO criteria).
- •Patients must be on treatment with metformin. Any form of treatment with SU compounds will be discontinued and washed out for two weeks prior to the start of study drug.
- •eGFR ≥ 60 ml/min/1.73 m2 (estimated by MDRD formula)
- •Fertile female patients must use chemical, hormonal and mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening
- •Patients must be on antihypertensive treatment or having elevated blood pressure (SBP ≥130 mm Hg and DBP ≥80 mmHg), lower than 170/105 mm Hg at baseline and the patients must be stable antihypertensive medication for at least 4 weeks prior to baseline
- •Patients must be on stable hypoglycemic medication for at least two weeks before the first visit.
- •Must be able to communicate with the investigator
排除标准
- •Ongoing insulin therapy
- •BP > 170/105 mm Hg at baseline
- •Type 1 diabetes mellitus
- •Chronic pancreatitis / previous acute pancreatitis
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
- •Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
- •Inflammatory bowel disease
- •Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
- •Previous bowel resection
- •Body mass index <18.5 kg/m2
- •Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
- •Clinical signs of diabetic gastroparesis
- •Impaired liver function (transaminases > two times upper reference levels)
研究组 & 干预措施
Liraglutide
single-group study were participants recieve Liraglutide
干预措施: liraglutide (Drug)
结局指标
主要结局
Change in ambulatory blood pressure
时间窗: 50 days
Change in 24h BP from day 1 to day 49 (baseline to end of treatment) and time to statistically significant change in BP 24h after initiation of or increased dose of liraglutide
次要结局
- Change in ECV(50 days)
- Washout analysis(21)
研究者
Peter Rossing
Director of Research, Chief Physician, DMSc
Steno Diabetes Center Copenhagen