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

NCT ID: NCT01626469

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

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)

Group Type ACTIVE_COMPARATOR

Captopril

Intervention Type DRUG

25mg Captopril

placebo

Intervention Type DRUG

placebo

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)

Group Type PLACEBO_COMPARATOR

Captopril

Intervention Type DRUG

25mg Captopril

placebo

Intervention Type DRUG

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Captopril

25mg Captopril

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Norman K. Hollenberg, MD, PhD

Director of Physiologic Research Division, Department of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Norman K Hollenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

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

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

617-732-6901

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011P002805

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Microvascular Reactivity.
NCT00259701 COMPLETED