Unravelling the Association Between Neurovascular Uncoupling and Autonomic Neuropathy in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Neurovascular coupling
研究概览
简要总结
Diabetes is a growing global health care challenge. Diabetes patients may also suffer from cardiovascular autonomic neuropathy (CAN) which may affect cerebral perfusion. The main purpose of this project is to investigate the association between CAN and disturbances in the neurovascular coupling in type 2 diabetes patients. Moreover, the purpose is also to investigate coherence between CAN and the enteric nervous system. Finally, this project aims at delineating microstructural changes in the brain tissues as a consequence of CAN.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of type 2 diabetes (Patients)
- •Age between 50-70 years (All)
- •Presence of CAN as diagnosed by cardiovascular reflex tests with two or three pathological results (Patients with CAN only)
- •Exclusion of CAN as diagnosed by cardiovascular reflex tests with no pathological results (Patients without CAN and HC only)
排除标准
- •Participants receiving treatment with direct effects on noradrenergic or cholinergic signaling (for example beta-blockers, tricyclic antidepressants, SSRI's) (All)
- •Acute infections (All)
- •Thyroid disease (All)
- •Substance or alcohol abuse (All)
- •Atrial fibrillation or flutter (All)
- •Respiratory failure (All)
- •Participants in active laser treatment for retinopathy, will be excluded from the Valsalva test (Patients)
- •Non-diabetic causes of neuropathy including a medical history of vitamin B12 deficiency, folic acid deficiency, rheumatoid arthritics, amyloidosis, HIV, syphilis, Borreliosis, drug induced neuropathy and neuropathy caused by toxins (All)
- •Claustrophobia (All)
- •Implanted pacemakers or remaining pacemaker electrodes (All)
- •Previous heart or brain surgery with use of metal clips (All)
- •Any form of non-MR-compatible implants
- •Non-compliance with the study protocol as judged by the investigators (All)
- •Concurrent participation in an intervention study (Patients)
- •Participants who by judgments of the investigator, is incapable of participating (All)
结局指标
主要结局
Neurovascular coupling
时间窗: 1 hour
Ratio between oxygen delivery/oxygen consumption by MRI during visual and hypercapnic stimulation
Regional splanchnic blood (superior mesenteric artery) flow increase in response to meal test
时间窗: 3 hours
Structural differences in brain tissue
时间窗: 1 hour
Change in blood levels of gastrointestinal hormones and markers of metabolism following meal test
时间窗: 3 hours
Cerebrovascular reactivity
时间窗: 1 hour
Change in CBF between normocapnia and hypercapnia
次要结局
未报告次要终点
研究者
Hartwig R. Siebner
Professor, DMSc
Danish Research Centre for Magnetic Resonance