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Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626469
First Posted: June 22, 2012
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Eye Blood Flow and the Kidney

Resource links provided by NLM:


Further study details as provided by Norman K. Hollenberg, MD, PhD, 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 ]
    Eye blood flow will be measured at baseline and post drug time points (3 total)


Secondary Outcome Measures:
  • Change in blood pressure from baseline [ Time Frame: Every 15 minutes for 3 hours ]
    Blood pressure will be monitored throughout the study starting at baseline

  • Change in renal plasma flow (RPF) from baseline [ Time Frame: 1 hour post drug, 2 hours post drug, 3 hours post drug ]
    Renal Plasma Flow (to measure kidney function) will be measured at baseline and post drug time points (3 total)


Estimated Enrollment: 24
Actual Study Start Date: May 2012
Estimated Study Completion Date: January 31, 2019
Estimated Primary Completion Date: January 31, 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626469


Locations
United States, Massachusetts
Brigham and Women's Hospital
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
First Submitted: June 19, 2012
First Posted: June 22, 2012
Last Update Posted: October 26, 2017
Last Verified: October 2017

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