Clinical trial NCT05449782: Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes
Official title: Proof-of-concept Study to Investigate Hand and Foot Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes Participant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microangiopathy, Diabetic
Polyphenol
Optical Tomography
Vascular Endothelium
Arterial Stiffness
Healthy Participants
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 group (healthy and type 2 diabetes) randomised controlled cross-over (2-period, 2-sequence) study
Primary purpose: BASIC_SCIENCE

Brief summary: The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. Specific diets with high polyphenol content are associated with lower incidence of cardiovascular disease and can improve macrovascular function when consumed acutely and chronically. Which role the smallest blood vessels (microcirculation) play in this and if the microcirculation responds to therapies is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation.

The current randomised controlled cross-over proof-of-concept study will test the acute effect of a cocoa flavanol intervention on cutaneous microvascular structure and function of hands and feet together with macrovascular function of upper and lower extremities in healthy and type 2 diabetes participants. It is the hypothesis that cocoa flavanol intervention as compared to placebo can acutely increase microvascular vasodilation and macrovascular endothelial function in arms and legs together with arterial stiffness in both healthy and type 2 diabetes participants.


Eligibility criteria: Healthy:

Inclusion Criteria:

* Healthy, 20-70 years
* BMI 20-30 kg/m\^2

Exclusion Criteria:

* Diabetes mellitus
* Symptoms of acute infection
* Cardiac rhythm other than sinus
* Active malignancy
* Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
* Active vasoactive medication.

Type 2 Diabetes:

Inclusion Criteria:

* Type 2 diabetes mellitus
* 20-70 years
* BMI 20-30 kg/m\^2

Exclusion Criteria:

* Symptoms of acute infection
* Cardiac rhythm other than sinus
* Active malignancy
* Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
* Active vasoactive medication.

Primary outcomes:
measure: Microvascular dilation
timeFrame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
measure: Macrovascular endothelial function
timeFrame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Secondary outcomes:
measure: Arterial stiffness
timeFrame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
measure: Blood pressure
timeFrame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
measure: Leg perfusion pressure
timeFrame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Other outcomes:
measure: Photoplethysmography (PPG) based pulse wave velocity (PWV)
timeFrame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
measure: Photoplethysmography (PPG) blood flow
timeFrame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
Study officials:
affiliation: University of Surrey, Department of Clinical and Experimental Medicine
name: Christian Heiss, Prof.
role: PRINCIPAL_INVESTIGATOR
References: