Eye Blood Flow and the Kidney

This study is currently recruiting participants.
Verified November 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01626469
First received: June 19, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Captopril
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Eye Blood Flow and the Kidney

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in ophthalmic artery blood flow from baseline [ Time Frame: 1 hour post drug, 2 hours post drug, 3 hours post drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
placebo
Active Comparator: Captopril Drug: Captopril
25mg Captopril

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Heart Attack or Stroke within the last 6 months
  • Pregnant or lactating females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626469

Contacts
Contact: Siobhan Boyce 617-732-6901 sboyce@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Norman K Hollenberg, MD, PhD Brigham and Women's Hospital
Study Director: Ebrahim Barkoudah, M.D.,M.P.H. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Norman K. Hollenberg, MD, PhD, Director of Physiologic Research Division, Department of Radiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01626469     History of Changes
Other Study ID Numbers: 2011P002805
Study First Received: June 19, 2012
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Captopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014