Back to Search
Start Over
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
- Source :
- FRONTIERS IN CARDIOVASCULAR MEDICINE, Frontiers in Cardiovascular Medicine, Frontiers in Cardiovascular Medicine, Frontiers Media, 2021, Frontiers in cardiovascular medicine, 8, pp.602086. ⟨10.3389/fcvm.2021.602086⟩, Frontiers in cardiovascular medicine, 8:602086. Frontiers Media S.A., Frontiers in Cardiovascular Medicine, Vol 8 (2021), Frontiers in Cardiovascular Medicine, 2021, Frontiers in cardiovascular medicine, 8, pp.602086. ⟨10.3389/fcvm.2021.602086⟩
- Publication Year :
- 2021
-
Abstract
- 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.
- Subjects :
- lcsh:Diseases of the circulatory (Cardiovascular) system
medicine.medical_specialty
vascular reactivity
medicine.drug_class
ENDOTHELIAL FUNCTION
FLOW-MEDIATED VASODILATION
Population
030209 endocrinology & metabolism
DARK CHOCOLATE
Type 2 diabetes
Cardiovascular Medicine
RICH COCOA
030204 cardiovascular system & hematology
Essential hypertension
Study Protocol
03 medical and health sciences
0302 clinical medicine
[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system
BRACHIAL-ARTERY
Diabetes mellitus
Internal medicine
medicine
Medicine and Health Sciences
OXIDATIVE STRESS
Antihypertensive drug
education
INSULIN-RESISTANCE
HDL CHOLESTEROL
education.field_of_study
NITRIC-OXIDE
business.industry
INFRARED SPECTROSCOPY NIRS
Type 2 Diabetes Mellitus
blood pressure
[SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
medicine.disease
cocoa flavanols
Crossover study
3. Good health
muscular oxygenation
Blood pressure
lcsh:RC666-701
antihypertensive drugs
type 2 diabetes
[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology
Cardiology
business
Cardiology and Cardiovascular Medicine
Subjects
Details
- Language :
- English
- ISSN :
- 2297055X
- Database :
- OpenAIRE
- Journal :
- FRONTIERS IN CARDIOVASCULAR MEDICINE, Frontiers in Cardiovascular Medicine, Frontiers in Cardiovascular Medicine, Frontiers Media, 2021, Frontiers in cardiovascular medicine, 8, pp.602086. ⟨10.3389/fcvm.2021.602086⟩, Frontiers in cardiovascular medicine, 8:602086. Frontiers Media S.A., Frontiers in Cardiovascular Medicine, Vol 8 (2021), Frontiers in Cardiovascular Medicine, 2021, Frontiers in cardiovascular medicine, 8, pp.602086. ⟨10.3389/fcvm.2021.602086⟩
- Accession number :
- edsair.doi.dedup.....38dc73e89f773b300c41ea67952e75f8