An observational study in Diabetes, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-03-31.
Sponsored by Brigham and Women's Hospital · Observational
Observing how cocoa effects the cardiovascular and renal system.
Study designed to assess the vascular benefits of drinking Cocoa that is rich in polyphenols. Vascular beds studied will include kidney, brain, eye, and periphery (finger). Time course of the effects will be studied in healthy normal (including elderly), and also in subjects with Type I and Type II diabetes. Renal blood flow will be determined by PAH/In u test clearance. Cranial ultrasound will be used to measure brain blood flow. Retinal blood flow will be assessed by specialized ultrasound/doppler device. Peripheral blood flow is measured by plethysmography. Urine and blood samples will be assayed for routine physiologic parameters, including hormone assessment, and also for the presence of cocoa metabolites.
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 228 is close to the median of 210 across 1,358 observational studies indexed under Hypertension.
Browse Hypertension studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Diabetic (Type I and II)
Inclusion Criteria: Diabetes (Type I and II), with or without Hypertension, blood pressure \<165/105
Exclusion Criteria: Under 18 or over 85 years old, women who are pregnant or able to become pregnant, history of heart attack, stroke or chest pain within the past 6 months, kidney disease, heart disease, severe high blood pressure not controlled by medication
Polyphenol rich or poor cocoa was administered to study subjects to measure hemodynamic responses and the role of nitric oxide in the renal vasodilator response.
Hemodynamic Measurements
Time frame: Hourly measurements (5-6 hours total)
Blood Pressure
Time frame: Hourly (5-6 hours)
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital