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

Primary Purpose

Vascular Complications, Diabetic

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
Placebo
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vascular Complications, Diabetic focused on measuring flavanols, diabetes type 2, essential hypertension, peripheral vascular function

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy persons

Persons with essential hypertension

Persons with type 2 diabetes

Arm Description

In this interventional study the investigators ask the patient (healthy persons) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo

In this interventional study the investigators ask the patient (persons with essential hypertension) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo

In this interventional study the investigators ask the patient (persons with type 2 diabetes) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo

Outcomes

Primary Outcome Measures

FMD -Flow mediated dilatation test
Flow mediated dilatation test

Secondary Outcome Measures

blood pressure analysis
analysis of changes in systolic or diastolic blood pressure

Full Information

First Posted
September 28, 2018
Last Updated
April 19, 2021
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03722199
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Complications, Diabetic
Keywords
flavanols, diabetes type 2, essential hypertension, peripheral vascular function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The different capsules are separated into 2 boxes but both sorts of capsules have the same colour and size. They just have a different number marked on the white box. During the investigation day, the participant chooses an envelope marked with number 1 or number 2 leading to the decision of the box and thus the capsules they will get.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy persons
Arm Type
Experimental
Arm Description
In this interventional study the investigators ask the patient (healthy persons) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo
Arm Title
Persons with essential hypertension
Arm Type
Experimental
Arm Description
In this interventional study the investigators ask the patient (persons with essential hypertension) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo
Arm Title
Persons with type 2 diabetes
Arm Type
Experimental
Arm Description
In this interventional study the investigators ask the patient (persons with type 2 diabetes) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
Other Intervention Name(s)
flavanoids
Intervention Description
single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
single intake of capsules with a placebo
Primary Outcome Measure Information:
Title
FMD -Flow mediated dilatation test
Description
Flow mediated dilatation test
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
blood pressure analysis
Description
analysis of changes in systolic or diastolic blood pressure
Time Frame
25 minutes
Other Pre-specified Outcome Measures:
Title
Near-infrared spectroscopy during exercise
Description
analysis of changes in oxygenated blood during exercise
Time Frame
25 minutes
Title
exercise test with hand held dynamometer
Description
analysis of changes in maximal capacity
Time Frame
25 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samyah Shadid, Prof. Dr.
Organizational Affiliation
Universal hospital of Ghent and university of Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ghent
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33791343
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.
Results Reference
derived

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

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