scholarly journals Acute Effects of Cocoa Flavanols on Blood Pressure and Peripheral Vascular Reactivity in Type 2 Diabetes Mellitus and Essential Hypertension: A Protocol for an Acute, Randomized, Double-Blinded, Placebo-Controlled Cross-Over Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Anouk Tanghe ◽  
Bert Celie ◽  
Samyah Shadid ◽  
Ernst Rietzschel ◽  
Jos Op ‘t Roodt ◽  
...  

Introduction: 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.Methods and Analysis: 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.Clinical Trial Registration:www.Clinicaltrials.gov, identifier: NCT03722199.

2020 ◽  
Vol 16 (4) ◽  
pp. 623-634
Author(s):  
T. Yu. Demidova ◽  
O. A. Kislyak

Arterial hypertension (AH) is powerful and modifying factor of developing macrovascular and microvascular complications of diabetes. Patients with AH and diabetes belong to group with high and very high levels risk of developing cardiovascular complications and chronic kidney disease. The combination of type 2 diabetes mellitus and AH dramatically increases the risk of developing terminal stages of microvascular and macrovascular diabetic complications: blindness, end-stage chronic kidney disease, amputation of the lower extremities, myocardial infarction, cerebral stroke, worsens the patients prognosis and quality of life. There is ample evidence that blood pressure control in diabetic patients may be critical for improving long-term prognosis. This observation does not lose its relevance even with the emergence of new antidiabetic drugs with proven cardio- and nephroprotective effects. Modern clinical researchers and meta-analysis show the priority of combined antihypertensive therapy, which increases the efficacy of blood pressure correction and prophylaxis of long-term complications in patients with type 2 diabetes. In this article we want to pay attention to features of AH in patients with diabetes, to bi-directional pathogenic mechanisms, to discuss the new algorithms of the treatment and therapeutic needs of these patients. It is important to accent the understanding of the integrity and unity of pathogenic mechanisms which are needed in correction. Innovative antihyperglycemic therapy demonstrates the ability of blood pressure decrease. The synergy of effects let us successfully realize the strategy of multi-factor control and reduce a risk of micro- and macrovascular complications.


Author(s):  
Hadi Bazyar ◽  
Seyed Ahmad Hosseini ◽  
Sirous Saradar ◽  
Delsa Mombaini ◽  
Mohammad Allivand ◽  
...  

Abstract Background In patients with type 2 diabetes mellitus (T2DM) the inflammatory and metabolic responses to epigallocatechin-3-gallate (EGCG) are unknown. Objectives Evaluate the impacts of EGCG on metabolic factors and some biomarkers of stress oxidative in patients with T2DM. Methods In this randomized, double-blind, placebo-controlled trial, 50 patients with T2DM consumed either 2 tablets (300 mg) EGCG (n=25) or wheat flour as placebo (n=25) for 2 months. The total antioxidant capacity (TAC), interleukin-6 (IL-6), lipid profile, mean arterial pressure (MAP), atherogenic index of plasma (AIP) were evaluated before and after the intervention. Results The finding of present study exhibited a significant increase in the serum levels of TAC after the EGCG supplementation (p=0.001). Also, in compare with control group, the mean changes of TAC were significantly higher in supplement group (p=0.01). In intervention group, a significant decrease was observed in the mean levels of triglyceride, total cholesterol, diastolic blood pressure (DBP), AIP, and MAP (p<0.05). Taking EGCG resulted in the mean changes of total cholesterol, MAP and DBP were significantly lower in compare with control group (p<0.05). Conclusions This study recommended that EGCG supplementation may be improved blood pressure, lipid profile, AIP, and oxidative status in patients with T2DM.


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