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

Eye Blood Flow and the Kidney

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01626469

Enrollment

Registered

2012-06-22

Start date

2012-05-31

Completion date

2020-09-30

Last updated

2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DRUGCaptopril

25mg Captopril

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in ophthalmic artery blood flow from baseline	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

Measure	Time frame	Description
Change in blood pressure from baseline	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	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)

Countries

United States

Contacts

Primary ContactEbrahim Barkoudah, M.D.,M.P.H.

ebarkoudah@partners.org617-732-6901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026