跳至主要内容
临床试验/NCT06067113
NCT06067113招募中不适用

Hemodynamic and Functional Characteristics of the Cerebral Circulation in Obesity

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月15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
40
试验地点
1
主要终点
Mean flow velocity in middle cerebral artery

研究概览

简要总结

This prospective study is intended to explore differences in the cerebral hemodynamics and vascular functional characteristics between obese and normo-constituted patients; as well as the changes in the hemodynamic and functional characteristics in those same obese patients following the intense weight-loss that happens after bariatric surgery.

详细描述

Obesity, defined by the World Health Organization (WHO) as a body mass index of 30 or higher, is reaching epidemic proportions worldwide, with some 2.8 million attributable deaths annually. Initially linked to countries with higher incomes, it is now a serious health problem in countries with medium and low incomes.

The increase in body mass index from overweight to obesity is linearly correlated with an increase in coronary and cerebral vascular events, as well as death from vascular causes. Apart from the fact that obese patients are at higher risk of having classic vascular risk factors (independently associated with atherosclerosis and a risk of vascular events), the evident linear relationship between obesity and vascular pathology suggests the existence of pathophysiological mechanisms related to the accumulation of fat that cause structural and functional damage to the vascular system.

Adipokines are a group of pro-inflammatory peptides specifically secreted by fat tissue that have been linked to inflammatory activity, endothelial dysfunction, and insulin resistance in overweight and obese conditions. From these studies, a wealth of knowledge is drawn on the relationship of obesity with large-vessel atherosclerosis; but yet, few studies have focused on the particular relationship of obesity on the cerebral vasculature, despite the strong epidemiological relationship between obesity in middle age (and vascular risk factors in general) and cognitive deficits and vascular dementia in the elderly, possibly driven to a large extent by cerebral small vessel disease.

Small vessel disease (including both radiological signs on MRI in the form of white matter lesions, lacunar infarcts and/or cognitive impairment, and vascular dementia/Alzheimer's disease) have been positively correlated in several retrospective and prospective studies with the Gosling index or pulsatility index (PI) obtained by transcranial Doppler study in the middle cerebral artery. In recent years, much importance has been attached to the potential deleterious impact that small cerebral vessel disease in middle ages may have on degenerative brain diseases over 60 years of age, however, we have not identified a specific study of haemodynamic factors of cerebral circulation in middle-aged patients.

Obese patients with an indication for bariatric surgery constituted, in our opinion, an excellent model for the study of these potential haemodynamic factors (surrogate markers of subclinical cerebrovascular disease) in two ways: by comparing them with normal-constituted volunteers; as well as comparing them with themselves once they achieve an effective reduction in their body weight after surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mean flow velocity in middle cerebral artery

时间窗: through study completion, an average of 1 year

Mean flow velocity in middle cerebral artery

次要结局

  • Intima-media thickness in distal CCA(through study completion, an average of 1 year)
  • Ankle-brachial index(through study completion, an average of 1 year)
  • Endothelium-dependent brachial artery vasodilation(through study completion, an average of 1 year)

研究者

发起方
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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