Eye Blood Flow and the Kidney

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 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: July 18, 2016
Last verified: July 2016
  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 ]
  • Change in renal plasma flow (RPF) from baseline [ Time Frame: 1 hour post drug, 2 hours post drug, 3 hours post drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in blood pressure from baseline [ Time Frame: Every 15 minutes for 3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Captopril 25 mg (Admission 1, Day 1, low salt diet) Matched Placebo (Admission 1, Day 2, low salt diet) Captopril 25 mg (Admission 2, Day 1, high salt diet) Matched Placebo (Admission 2, Day 2, high salt diet)
Drug: Captopril
25mg Captopril
Drug: placebo
placebo
Placebo Comparator: Captopril
Matched Placebo (Admission 1, Day 1, low salt diet) Captopril 25 mg (Admission 1, Day 2, low salt diet) Matched Placebo (Admission 2, Day 1, high salt diet) Captopril 25 mg (Admission 2, Day 2, high salt diet)
Drug: Captopril
25mg Captopril
Drug: placebo
placebo

Detailed Description:

The overall objective of this study is to ascertain if salt intake affects ophthalmic artery (OA) blood flow. In addition, we will study both the eye and kidney response to ACE inhibition compared to placebo while controlling salt intake in subjects with Type 2 diabetes mellitus.

We hypothesize that salt intake will affect OA blood flow.

We will initially look at both eye and renal response to subjects on a low salt diet (10mEq Na/day) followed by response to high salt diet (200mEq Na/day). In addition, we may look at eye response while subjects consume their regular diet.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626469

Contacts
Contact: Ebrahim Barkoudah, M.D.,M.P.H. 617-732-6901 ebarkoudah@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

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: July 18, 2016
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
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 28, 2016