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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Eye Blood Flow and the Kidney

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01626469
• Other study ID #: 2011P002805
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2012
• Est. completion date: September 2020

Study information

• Verified date: July 2019
• Source: Brigham and Women's Hospital
• Contact: Ebrahim Barkoudah, M.D.,M.P.H.
• Phone: 617-732-6901
• Email: ebarkoudah[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Captopril
25mg Captopril
• placebo
placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ophthalmic artery blood flow from baseline	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	Change in blood pressure from baseline	Blood pressure will be monitored throughout the study starting at baseline	Every 15 minutes for 3 hours
Secondary	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)	1 hour post drug, 2 hours post drug, 3 hours post drug