Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients
Eye Blood Flow and the Kidney
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started May 2012
Longer than P75 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 19, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedAugust 1, 2019
July 1, 2019
8.3 years
June 19, 2012
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in blood pressure from baseline
Every 15 minutes for 3 hours
Change in renal plasma flow (RPF) from baseline
1 hour post drug, 2 hours post drug, 3 hours post drug
Study Arms (2)
Arm A
ACTIVE COMPARATORCaptopril 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
PLACEBO COMPARATORMatched 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)
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes Mellitus
You may not qualify if:
- Type 1 Diabetes Mellitus
- Heart Attack or Stroke within the last 6 months
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman K Hollenberg, MD, PhD
Brigham and Women's Hospital
- STUDY DIRECTOR
Ebrahim Barkoudah, M.D.,M.P.H.
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Physiologic Research Division, Department of Radiology
Study Record Dates
First Submitted
June 19, 2012
First Posted
June 22, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
August 1, 2019
Record last verified: 2019-07