Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Brigham and Women's Hospital228 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

228

Conditions

Diabetes

Interventions

CocoaOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham & Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Hemodynamic Measurements

Time frame: Hourly measurements (5-6 hours total)

Secondary Outcomes

Blood Pressure

Time frame: Hourly (5-6 hours)

Data from ClinicalTrials.gov

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