Clinical trial NCT03722199: Effects of Flavanoids in Essential Hypertension, Type 2 Diabetes and Healthy Persons
Official title: Effects of Flavanoids on Acute Peripheral Vascular Reactivity in Essential Hypertension, Type 2 Diabetes and Healthy Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Complications, Diabetic
Keywords: flavanols
diabetes type 2
essential hypertension
peripheral vascular function
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Flavanols are natural substances who are frequently found in our nutrition. A lot of research has already been executed in the past to investigate what effects this flavanols could have in the human population. Based on these examinations, the investigators think and suggest that flavanols can have positive effects on the vascularly system, more specifically on the peripheral and cerebral blood vessels. The effects are only observed in a healthy populations, meanwhile patient populations like diabetes patients could really benefit from this. This is why the investigators will execute this study.

Detailed description: The study population is divided into 3 main groups, namely healthy controls, patients with diabetes type 2 (defined by American Diabetes Association's (ADA)) and patients with essential hypertension (the latter group is again divided into 3 subgroups: use of betablockers, angiotensin-converting enzyme (ACE)-inhibitors, angiotensin-receptor blockers (ARBs). Each main goup will consist of minimal 20 subjects.

In this interventional study the investigators ask the patient to come twice. One time they get capsules with real flavanols and the other time they get capsules with a placebo. The study will be double blinded so nor the investigators, nor the patients now at which investigation they get the real flavanols or the placebo.

Before and after the intake of these capsules, a few measurements will take place. These measurements will be compared on the one hand with the second investigation day (inter-patients and intra-patient) and on the other hand with the pre-intake measurements (intra-patient).

The different examinations are a Flow-mediated dilatation (FMD) test, blood pressure analysis and an exercise test.

The investigator who performs the FMD-test, followed a course and needed to pass an examination.

The blood pressure measurements will be continuously for 20 minutes to avoid to much bias.

Eligibility criteria: Inclusion Criteria:

* men and woman, age 18 - 85 years old, diabetes type 2 and/or using 1 sort of blood pressure lowering medication (betablockers, calcium-antagonists, RAAS-inhibitors)

Exclusion Criteria:

* GENERAL: diabetes type 1, maturity-onset diabetes of youth (MODY), Latent Autoimmune Diabetes of the Adult (LADA), smokers, alcohol abuse, active cancer, chronic inflammatory disease
* MICROVASCULAR: retinopathy, diabetic/hypertensive nephropathy, peripheral sensoric neuropathy, autonomic neuropathy
* MACROVASCULAR: cardiovascular diseases, cerebrovascular diseases, active or chronic palindromic vasculitis
* MEDICATION with impact on endothelial function: NO-containing medication, phosphodiesterase Type 5 -inhibitors
* DISEASES who can affect the exercise test: chronic obstructive pulmonary disease (COPD) with Global Initiative for Chronic Obstructive Lung Disease (GLOD) -stages III and IV, Heart failure class 3 and 4, serious musculoskeletal diseases
* OTHER: pregnancy

Primary outcomes:
measure: FMD -Flow mediated dilatation test
timeFrame: 20 minutes
Secondary outcomes:
measure: blood pressure analysis
timeFrame: 25 minutes
Other outcomes:
measure: Near-infrared spectroscopy during exercise
timeFrame: 25 minutes
measure: exercise test with hand held dynamometer
timeFrame: 25 minutes
Locations:
city: Ghent
country: Belgium
facility: University of Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: Universal hospital of Ghent and university of Ghent
name: Samyah Shadid, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tanghe A, Celie B, Shadid S, Rietzschel E, Op 't Roodt J, Reesink KD, Heyman E, Calders P. 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. Front Cardiovasc Med. 2021 Mar 15;8:602086. doi: 10.3389/fcvm.2021.602086. eCollection 2021.