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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Captopril

placebo

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm A

Captopril

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Change in ophthalmic artery blood flow from baseline

Eye blood flow will be measured at baseline and post drug time points (3 total)

Secondary Outcome Measures

Change in blood pressure from baseline

Blood pressure will be monitored throughout the study starting at baseline

Change in renal plasma flow (RPF) from baseline

Renal Plasma Flow (to measure kidney function) will be measured at baseline and post drug time points (3 total)

Full Information

NCT ID

NCT01626469

First Posted

June 19, 2012

Last Updated

July 30, 2019

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01626469

Brief Title

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

Official Title

Eye Blood Flow and the Kidney

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (Actual)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

Arm Title

Captopril

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Captopril

Intervention Description

25mg Captopril

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Change in ophthalmic artery blood flow from baseline

Description

Eye blood flow will be measured at baseline and post drug time points (3 total)

Time Frame

1 hour post drug, 2 hours post drug, 3 hours post drug

Secondary Outcome Measure Information:

Title

Change in blood pressure from baseline

Description

Blood pressure will be monitored throughout the study starting at baseline

Time Frame

Every 15 minutes for 3 hours

Title

Change in renal plasma flow (RPF) from baseline

Description

Renal Plasma Flow (to measure kidney function) will be measured at baseline and post drug time points (3 total)

Time Frame

1 hour post drug, 2 hours post drug, 3 hours post drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ebrahim Barkoudah, M.D.,M.P.H.

Phone

617-732-6901

ebarkoudah@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norman K Hollenberg, MD, PhD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ebrahim Barkoudah, M.D.,M.P.H.

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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