Last reviewed · How we verify
NCT05449782
Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes
NA trial testing Cocoa flavanol in Microangiopathy, Diabetic in 22 participants. Completed in 17 May 2022.
1 June 2021
Quick facts
| Lead sponsor | University of Surrey |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 22 |
| Start date | 17 May 2021 |
| Primary completion | 1 June 2021 |
| Estimated completion | 17 May 2022 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Cocoa flavanol
- Placebo
Conditions studied
- Microangiopathy, Diabetic — all drugs for Microangiopathy, Diabetic →
- Polyphenol — all drugs for Polyphenol →
- Optical Tomography — all drugs for Optical Tomography →
- Vascular Endothelium — all drugs for Vascular Endothelium →
Sponsor
University of Surrey
Who can join
Adults 20 to 70, any sex, with Microangiopathy, Diabetic or Polyphenol. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05449782
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05449782 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Surrey
- Last refreshed: 8 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05449782.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing