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NCT Number: NCT03722199

Effects of Flavanoids in Essential Hypertension, Type 2 Diabetes and Healthy Persons

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.

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Key information

Conditions

Vascular Complications, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Endocrine System Diseases Essential Hypertension Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Dietary Supplement

single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Other names: flavanoids

Placebo

Other

single intake of capsules with a placebo

Primary outcomes

  1. FMD -Flow mediated dilatation test

    Time frame: 20 minutes

    Flow mediated dilatation test

Secondary outcomes

  1. blood pressure analysis

    Time frame: 25 minutes

    analysis of changes in systolic or diastolic blood pressure

Other outcomes

  1. Near-infrared spectroscopy during exercise

    Time frame: 25 minutes

    analysis of changes in oxygenated blood during exercise

  2. exercise test with hand held dynamometer

    Time frame: 25 minutes

    analysis of changes in maximal capacity

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Effects of Flavanoids on Acute Peripheral Vascular Reactivity in Essential Hypertension, Type 2 Diabetes and Healthy Persons

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2018
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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