MultI-eLectrode EndovaScular denervaTiOn in patieNts With Type 2 Diabetes mEllitus (MILESTONE) Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Oral Glucose Tolerance Test from baseline to 6 months
研究概览
简要总结
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might reduce sympathetic overactivity and improve glucose metabolism and insulin sensitivity. The purpose of this study is to evaluate the effects of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
详细描述
Sympathetic overactivity induces insulin resistance and type 2 diabetes mellitus (T2DM), so it is assumed that denervation might improve glucose metabolism and insulin sensitivity. Some clinical studies have shown that glucose metabolism is improved in patients with resistant hypertension both 1 and 3 months after denervation, and fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. But in some clinical studies, denervation did not lead to a significant improvement of insulin sensitivity ≤12 months after treatment, and no effect in systemic sympathetic activity was observed after denervation. Therefore, the efficacy of denervation on glucose metabolism is still in controversy. The investigators wish to investigate the effect of multi-electrode catheter-based endovascular denervation on glucose metabolism and insulin sensitivity in patients with T2DM.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years and ≤ 70 years old
- •Able and willing to provide informed consent
- •Patients with established type II diabetes mellitus (HbA1C>7.5%, diet or oral hypoglycaemic agents)
- •Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
- •Anticipated that patients are able to maintain a stable dose of medication for the duration of the study
排除标准
- •Arterial anatomy ineligible for endovascular denervation
- •History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation
- •Type 1 diabetes mellitus
- •Pregnant, nursing or planning to be pregnant
- •Orthostatic hypotension
- •eGFR <30 ml/min (MDRD formula)
- •Patients that have allergy to contrast agent
- •Myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
- •Cerebrovascular accidents and alimentary tract hemorrhage within 3 months before inclusion
- •Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial
结局指标
主要结局
Changes in Oral Glucose Tolerance Test from baseline to 6 months
时间窗: 6 months
To investigate the influence of endovascular denervation on Oral Glucose Tolerance Test (OGTT).
Changes in glycosylated hemoglobin from baseline to 6 months
时间窗: 6 months
To investigate the influence of endovascular denervation on glycosylated hemoglobin (HbA1c).
次要结局
- Changes in glycosylated hemoglobin up to 2 years(3, 12 and 24 months)
- Changes in Oral Glucose Tolerance Test up to 2 years(3, 12 and 24 months)
- Changes in catecholamine up to 2 years(3, 6, 12 and 24 months)
- Changes in creatinine up to 2 years(3, 6, 12 and 24 months)
- Changes in insulin up to 2 years(3, 6, 12 and 24 months)
- Changes in glucagon up to 2 years(3, 6, 12 and 24 months)
- Changes in blood pressure up to 2 years(3, 6, 12 and 24 months)
- Changes in blood urea nitrogen (BUN) up to 2 years(3, 6, 12 and 24 months)
研究者
Gao-jun Teng
President
Zhongda Hospital