NCT04700241已完成不适用
Acute Effects of Inorganic Nitrate on Brain Insulin-sensitivity in Abdominally Obese Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Brain insulin sensitivity
研究概览
简要总结
Disturbances in brain insulin-sensitivity are not only observed in abdominal obesity and type 2 diabetes mellitus (T2D), but also during brain aging and in dementia. Inorganic nitrate may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin, through beneficial effects on brain vascular function. Therefore, we now hypothesize that inorganic nitrate, which can be found in several vegetables such as beetroot, improves brain insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered insulin, in abdominally obese men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 - 60 years;
- •Waist circumference > 102 cm (abdominally obese);
- •Fasting plasma glucose ≤ 7.0 mmol/L;
- •Fasting serum total cholesterol ≤ 8.0 mmol/L;
- •Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg;
- •Stable body weight (weight gain or loss < 3 kg in the past three months);
- •Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study;
- •Willingness not to use antibacterial mouth wash or toothpaste, chewing-gum and tongue-scraping a week before the study;
- •No difficult venipuncture as evidenced during the screening visit.
排除标准
- •Left-handedness;
- •Current smoker, or smoking cessation < 12 months;
- •Diabetic patients;
- •Familial hypercholesterolemia;
- •Abuse of drugs;
- •More than 3 alcoholic consumptions per day;
- •Use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators;
- •Use medication to treat blood pressure, lipid or glucose metabolism;
- •Pharmacological treatment advised based on the Dutch general practitioners' association (NHG) for cardiovascular risk management;
- •Use of an investigational product within another biomedical intervention trial within the previous 1-month;
- •Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis;
- •Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident;
- •Specific contra-indications for MRI imaging, including pacemakers, surgical clips/material in body, metal splinters in eye, claustrophobia, or tattoos in the facial area, such as permanent make-up.
结局指标
主要结局
Brain insulin sensitivity
时间窗: Change from placebo intervention at 2 hours after supplement intake
MRI arterial spin labeling, cerebral blood flow measurements before and after a nasal insulin spray
次要结局
- Cold pressure test(Change from placebo at 4 hours after supplement intake)
- Postprandial metabolism (1)(During the 5.5 hours following supplement intake)
- Cardiometabolic risk markers (1)(Change from placebo at 4 hours after supplement intake)
- Cardiometabolic risk markers (4)(During the 5.5 hours following supplement intake)
- Cardiometabolic risk markers (3)(Change from placebo at 4 hours after supplement intake)
- Postprandial metabolism (2)(During the 5.5 hours following supplement intake)
- Brain vascular function(Change from placebo intervention at 2 hours after supplement intake)
- Vascular function markers(Change from fasting at 4 hours after supplement intake)
- Cardiometabolic risk markers (2)(Change from placebo at 4 hours after supplement intake)
研究者
研究点 (2)
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