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

Mass General Brigham

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Captopril; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01626469

2011P002805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Arm A

Active Comparator group

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)

Treatment:

Drug: placebo

Drug: Captopril

Captopril

Placebo Comparator group

Description:

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)

Treatment:

Drug: placebo

Drug: Captopril