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

This study is currently recruiting participants.

Verified by Brigham and Women's Hospital, November 2008

Sponsors and Collaborators:	Brigham and Women's Hospital Masterfoods
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00639665

Purpose

Observing how cocoa effects the cardiovascular system.

Condition
Diabetes

MedlinePlus related topics: Diabetes High Blood Pressure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Further study details as provided by Brigham and Women's Hospital:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole red blood cells will be retained for DNA analysis. Subjects may "opt-out" of genetic testing.

Estimated Enrollment:	300
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2012

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Diabetic

Criteria

Inclusion Criteria:

Diabetic

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639665

Locations

United States, Massachusetts
Brigham & Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Norman K. Hollenberg, M.D., Ph.D. 617-732-6901 nhollenberg@partners.org
Principal Investigator: Norman K Hollenberg, M.D., Ph.D.

Sponsors and Collaborators

Brigham and Women's Hospital

Masterfoods

Investigators

Principal Investigator:

Norman K Hollenberg, M.D., Ph.D.

Brigham and Women's Hospital

More Information

Responsible Party:	Brigham & Women's Hospital ( Norman K. Hollenberg, M.D., Ph.D. )
Study ID Numbers:	2000P-002347
Study First Received:	March 14, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00639665
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Cocoa, diabetes, polyphenols

Study placed in the following topic categories:

Metabolic Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Healthy
Metabolic disorder
Glucose Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009