Vascular Complications, DiabeticNCT03722199
Effects of Flavanoids in Essential Hypertension, Type 2 Diabetes and Healthy Persons
A study testing flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) in people with Vascular Complications, Diabetic, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Complications, Diabetic
- What is being tested?
- flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Flavanoids on Acute Peripheral Vascular Reactivity 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.
Read the 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.
- Conditions
- Vascular Complications, Diabetic
- Being tested
- flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances), Placebo
- Keywords
- flavanols, diabetes type 2, essential hypertension, peripheral vascular function
- Medical subject headings
- Diabetic Angiopathies, Diabetes Mellitus, Type 2, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)Dietary supplement
Also called flavanoids
single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
PlaceboOther
single intake of capsules with a placebo
| Study group | Role | What they receive |
|---|---|---|
| Healthy persons | Experimental | 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 Receives: Dietary Supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances); Other: Placebo |
| Persons with essential hypertension | Experimental | 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 Receives: Dietary Supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances); Other: Placebo |
| Persons with type 2 diabetes | Experimental | 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 Receives: Dietary Supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMD -Flow mediated dilatation test
Flow mediated dilatation test
Measured: 20 minutes
Secondary outcomes (1)
blood pressure analysis
analysis of changes in systolic or diastolic blood pressure
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Sep 2018
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Complications, DiabeticStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samyah Shadid, Prof. Dr., Principal investigator, Universal hospital of Ghent and university of Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722199
- Sponsor's protocol ID
- B670201835660
- Status last verified
- Aug 2020
- First submitted
- 28 Sep 2018
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33791343
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flavanoids on Acute Peripheral Vascular Reactivity in Essential Hypertension, Type 2 Diabetes and Healthy Persons
- ClinicalTrials.gov ID
- NCT03722199
- Acronym / sponsor ID
- B670201835660
- Conditions
- Vascular Complications, Diabetic
- Keywords
- flavanols, diabetes type 2, essential hypertension, peripheral vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy persons | Experimental | Dietary Supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances), Other: PlaceboIn 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 |
| Persons with essential hypertension | Experimental | Dietary Supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances), Other: PlaceboIn 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 |
| Persons with type 2 diabetes | Experimental | Dietary Supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances), Other: PlaceboIn 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)Also: flavanoidssingle intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) | Dietary supplement | Healthy persons, Persons with essential hypertension, Persons with type 2 diabetes |
| Placebosingle intake of capsules with a placebo | Other | Healthy persons, Persons with essential hypertension, Persons with type 2 diabetes |
Primary outcome
FMD -Flow mediated dilatation test
Time frame: 20 minutes
Flow mediated dilatation test
1 secondary outcome
blood pressure analysis
Time frame: 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 33791343Tanghe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samyah Shadid, Prof. Dr. principal investigator
Universal hospital of Ghent and university of Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) in people with Vascular Complications, Diabetic, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMD -Flow mediated dilatation test (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.