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

Vascular Complications, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722199
• Other study ID #: B670201835660
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 20, 2021

Study information

• Verified date: August 2020
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Angiopathies
• Essential Hypertension
• Hypertension
• Vascular Complications, Diabetic

Intervention

Dietary Supplement:
• flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Other:
• Placebo
single intake of capsules with a placebo

Locations

Country	Name	City	State
Belgium	University of Ghent	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Near-infrared spectroscopy during exercise	analysis of changes in oxygenated blood during exercise	25 minutes
Other	exercise test with hand held dynamometer	analysis of changes in maximal capacity	25 minutes
Primary	FMD -Flow mediated dilatation test	Flow mediated dilatation test	20 minutes
Secondary	blood pressure analysis	analysis of changes in systolic or diastolic blood pressure	25 minutes