Tanghe Anouk, Celie Bert, Shadid Samyah, Rietzschel Ernst, Op 't Roodt Jos, Reesink Koen D, Heyman Elsa, Calders Patrick
Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.
Univ. Lille, Univ. Artois, Univ. Littoral Côte d'Opale, ULR 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, Lille, France.
Front Cardiovasc Med. 2021 Mar 15;8:602086. doi: 10.3389/fcvm.2021.602086. eCollection 2021.
Patients with type 2 diabetes mellitus are at high risk to develop vascular complications resulting in high morbidity and mortality. Cocoa flavanols are promising nutraceuticals with possible beneficial vascular effects in humans. However, limited research is currently available on the vascular effects in a diabetic population with inconsistent results. Possible reasons for this inconsistency might be heterogeneity in the given intervention (dose per time and day, single dose vs. split-dose, placebo formula) and the studied population (blood pressure at baseline, duration of diabetes, use of vasoactive antihypertensive and antidiabetic drugs, sex). Therefore, we aimed to develop a randomized, double-blinded, placebo-controlled cross-over trial to investigate whether cocoa flavanols have an acute impact on blood pressure and vascular reactivity in patients with type 2 diabetes with and without arterial hypertension. We will include participants in four groups: (i) patients with type 2 diabetes without arterial hypertension, (ii) patients with type 2 diabetes with arterial hypertension and 1 antihypertensive drug, (iii) non-diabetic participants with essential hypertension and 1 antihypertensive drug, and (iv) healthy controls. All participants will complete the same protocol on both testing days, consuming high-flavanol cocoa extract (790 mg flavanols) or placebo. Macrovascular endothelial function (flow-mediated dilation) and blood pressure will be measured before and after capsule ingestion. Forearm muscle vasoreactivity (near-infrared spectroscopy) and brachial artery blood flow (echo-doppler) will be assessed in response to a dynamic handgrip exercise test after capsule ingestion. Data will be analyzed with a random intercept model in mixed models. www.Clinicaltrials.gov, identifier: NCT03722199.
2型糖尿病患者发生血管并发症的风险很高，会导致高发病率和死亡率。可可黄烷醇是很有前景的营养保健品，可能对人体血管产生有益影响。然而，目前关于糖尿病患者血管影响的研究有限，结果也不一致。这种不一致的可能原因可能是给定干预措施（每次和每天的剂量、单剂量与分剂量、安慰剂配方）和研究人群（基线血压、糖尿病病程、血管活性抗高血压和抗糖尿病药物的使用、性别）的异质性。因此，我们旨在开展一项随机、双盲、安慰剂对照的交叉试验，以研究可可黄烷醇是否对患有和未患有动脉高血压的2型糖尿病患者的血压和血管反应性有急性影响。我们将纳入四组参与者：（i）无动脉高血压的2型糖尿病患者，（ii）患有动脉高血压且正在服用1种抗高血压药物的2型糖尿病患者，（iii）患有原发性高血压且正在服用1种抗高血压药物的非糖尿病参与者，以及（iv）健康对照者。所有参与者在两个测试日都将完成相同的方案，服用高黄烷醇可可提取物（790毫克黄烷醇）或安慰剂。在摄入胶囊前后测量大血管内皮功能（血流介导的血管舒张）和血压。在摄入胶囊后，通过动态握力运动试验评估前臂肌肉血管反应性（近红外光谱法）和肱动脉血流（超声多普勒）。数据将在混合模型中用随机截距模型进行分析。Clinicaltrials.gov网站，标识符：NCT03722199。
