NCT05673668招募中不适用
Clinical Mechanism of Endovascular Denervation (EDN) for the Treatment of Type 2 Diabetes
Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes of islet secretory function (HOMA-β)
研究概览
简要总结
This is a prospective, single-center, single-arm, self-controlled study to evaluate the effects of endovascular denervation (EDN) on insulin secretory function and insulin sensitivity in the treatment of type 2 diabetes mellitus (T2DM) .
详细描述
This is a prospective, single-center, single-arm, self-controlled study. Patients with diagnosed T2DM and poor glycemic control (i.e.. glycated hemoglobin A1c (HbA1c) between 7.5% and 10.5% despite one to three oral antidiabetic drugs (OAD) and/or insulin on the basis of metformin. All included subjects will accept EDN treatment and were followed up at 7, 30 days and 3, 6, 12 months. The primary objectives were evaluate the effects of EDN on insulin secretory function and insulin sensitivity in the treatment of 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with age of #18 years old and#75 years old (both ends included)
- •Subject (or legal guardian) understands the requirements and treatment of this clinical trial and agrees to and is able to complete the trial
- •Diagnosed with T2DM for ≤15 years (according to WHO criteria)
- •On the basis of metformin (daily dose ≥1000mg), using a combination of 1-3 OADs for more than last 3 months, with or without insulin (dose not limited). Defined OADs were: sulfonylureas/ glienides, thiazolidinediones and α-glycosidase inhibitors
- •Glycosylated hemoglobin (HbA1c) levels between 7.5% and 10.5% (based on baseline tests)
- •Body mass index (BMI) ≥ 18 and ≤40kg/m2
排除标准
- •T1DM or any secondary diabetes
- •History of aortic disease (such as aortic aneurysm or aortic dissection) or aortic surgery (including celiac artery dissection)
- •Baseline CTA examination revealed aortic aneurysm or aortic dissection, or abnormal anatomical structure of hepatic artery and its branches, or other vascular structure/status abnormalities (such as severe tortuosity or narrowing of the artery, endovascular thrombosis or unstable plaque, etc.) that were not suitable for endovascular denervation as determined by the researcher
- •More than 2 self-reported or documented events of severe hypoglycemia (defined as hypoglycemia with severe cognitive impairment requiring assistance) within the past 6 months
- •Patients who had a major cardiovascular and cerebrovascular event (MACCE), major surgery, severe infection, gastrointestinal bleeding, and acute pancreatitis in the past 6 months
- •Severe autonomic neuropathy (postural hypotension, etc.)
- •Severe liver insufficiency (ALT and/or AST above 3 times the normal upper limit or serum total bilirubin above 2 times the normal upper limit), renal insufficiency (eGFR < 60mL/ min/1.73m2). eGFR calculation formula is shown in Note e of Table 4.3 Data collection table.), chronic pancreatitis, cocoagulation disorder (PT, APTT or INR higher than 2 times of the normal upper limit; Platelet count < 80×109/L or ≥ 700×109/L) and malignant tumors
- •Suffering from mental illness and unable to cooperate
- •There were conditions that the researchers determined will affect the safety of the subjects or interfere with the evaluation of the test results
- •Patients not eligible for MRI (e.g. paramagnetic metal implants, claustrophobia, etc.)
- •Participating in or currently participating in other clinical studies within 3 months prior to enrollment
结局指标
主要结局
Changes of islet secretory function (HOMA-β)
时间窗: From baseline to 6 months
Changes of islet secretory function (HOMA-β, HOMA-IR) from baseline at 6 months post procedure
次要结局
- Changes in the time in range (TIR) over 14 days of glucose(From baseline to 12 months post procedure)
- Changes in liver fat content(From baseline to 6 months post procedure)
- Changes in liver function(From baseline to 6 months post procedure)
- Incidence of device or procedure-related major adverse events(From baseline to 12 months post procedure)
- Changes in the area under OGTT insulin release curve(From baseline to 12 months post procedure)
- Changes in blood lipids(From baseline to 12 months post procedure)
- Changes in Hba1c(From baseline to 12 months post procedure)
- Changes in the area under OGTT C-peptide release curve(From baseline to 12 months post procedure)
- Changes in the gastric emptying(From baseline to 12 months post procedure)
- Changes in metabolic-related hormones(From baseline to 6 months post procedure)
- Changes in insulin sensitivity(From baseline to 6 months post procedure)
- Changes in plasma cytokines(From baseline to 6 months post procedure)
- Changes in fecal microbiota(From baseline to 6 months post procedure)
- Changes in blood and fecal metabolome(From baseline to 6 months post procedure)
- Change of sympathetic nervous system activity(From baseline to 6 months post procedure)
研究者
Gao-jun Teng
Clinical Professor
Zhongda Hospital
研究点 (1)
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