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

July 30, 2019 updated by: Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital

Eye Blood Flow and the Kidney

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: placebo
placebo
Drug: Captopril
25mg Captopril
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: placebo
placebo
Drug: Captopril
25mg Captopril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 hour post drug, 2 hours post drug, 3 hours post drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 15 minutes for 3 hours
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)
1 hour post drug, 2 hours post drug, 3 hours post drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (ESTIMATE)

June 22, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P002805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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