Effect of L-arginine Supplementation on Microcirculation, Endothelial Function and Vascular Smooth Muscle of Young, Elderly and Patients With Sarcopenia and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in Endothelium-dependent and endothelium-independent vasodilation
研究概览
简要总结
This study aims was evaluated the effect of L-arginine on microcirculation, vasoreactivity / endothelial function and vascular smooth muscle of young and old women with Sarcopenia or Type 2 Diabetes Mellitus measured by Nailfold videocapillaroscopy and venous occlusion plethysmography before and after 14 days of consumption 5g oral L-arginine supplementation.
详细描述
Aging causes responsible endothelial changes, in part by a decrease in the blood flow of the skeletal muscles of the elderly. Reduction of muscle mass / function (Sarcopenia) and Diabetes Mellitus are frequent pathologies in the elderly. L-Arginine is a semi-essential amino acid precursor to nitric oxide synthesis (NO), an important vasodilator and protector cardiovascular.
Seventy-five women were allocated into three groups: twenty-five healthy young (HY) recruited among University students, and fifty women elderly, this was stratified in twenty-five healthy elderly (HE) control and twenty-five with hyperglycemia (HG) elderly from the ambulatories of the Geriatric and Diabetology at the State University of Rio de Janeiro (UERJ) and private supplementary health program. To control group was considered absence cardiovascular risk factor except advanced age. Participants were subjected to screening phase before being eligible for the study by telephone, which comprised of individual clinical history. All subjects signed the written Informed Consent Form enclosed in the protocol approved by Ethics Committee from the State University of Rio de Janeiro according to Helsinki Declaration.
The subjects elected for research made 4 visits to the Biovasc laboratory for data collection. First day: the protocol was explained and agreement from the voluntary obtained, followed and anamnesis and physical exam that included measure at-rest blood pressure, weight and height. Moreover, women examined after 6 hours fasting the microcirculation function using nailfold vidiocapilaroscopy (NVC), followed of the measure of forearm blood flow (FBF) and vascular reactivity by venous occlusion plethysmography (VOP). Second day: Venous blood sample collection after 12 hours fasting. In sequence, they realized whole-body dual-energy X-ray absorptiometry (DXA) to calculate the body composition main measure lean and fat mass. After, was delivered a box with 14 sachets content 5g L-arginine supplementation, and it was recommended to ingest with water 30 minutes before breakfast during 14 days. Third day: Return after the supplementation to realize measurement weight, and exams NVC and VOP. Fourth day: blood sample were taken after 12 hours fasting under effect of the L-arginine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •young women aged between 20 - 30 years, IMC < 24.9 kg/m2
- •older women over 65 years healthy, BMI <35 kg/m
- •Elderly women with or without a preexisting diagnosis of diabetes mellitus with fasting plasma glucose (FPG) > 100 mg/dL were classified into type 2 diabetes mellitus.
排除标准
- •involved type 1 diabetes mellitus
- •insulin use, cognitive impairment
- •disorders cardiometabolic
- •liver and/or kidney dysfunction
- •autoimmune diseases
- •rigorous exercise
- •uncontrolled hypertension with pressure level > 140/90 mmHg, with up to two antihypertensive drugs of different classes.
研究组 & 干预措施
Maltodextrin
Maltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
干预措施: Maltodextrin (Dietary Supplement)
L-arginine
L-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
干预措施: L-arginine (Dietary Supplement)
结局指标
主要结局
Changes in Endothelium-dependent and endothelium-independent vasodilation
时间窗: before and after 14 days of intervention
Changes in vasodilatation by endothelial reactivity and smooth muscle responsiveness were assessed by Venous occlusion plethysmography
Changes in Microcirculation
时间窗: before and after 14 days of intervention
Assessing microvascular changes in the peripheral circulation by microcirculatory image recordings were used Nailfold vidiocapilaroscopy.
次要结局
- Change in metabolic markers(before and after 14 days of intervention)
- change in circulating muscle growth and degradation factors(before and after 14 days of intervention)
- Body composition by DXA(before of intervention)
研究者
Gerusa Maritimo da Costa
Principal Investigator
Rio de Janeiro State University
