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

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Captopril; Drug: placebo

• Registration Number: NCT01626469
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Type 2 Diabetes Mellitus

Read More

Exclusion Criteria

• Type 1 Diabetes Mellitus
• Heart Attack or Stroke within the last 6 months
• Pregnant or lactating females

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm A	placebo	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)
Captopril	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)
Captopril	placebo	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)
Arm A	Captopril	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States