Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT01626469

Conditions

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Captopril

placebo

Study Details

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.

Conditions

Type 2 Diabetes Mellitus

Study ID

NCT01626469

Start date

May, 2012

Status verified date

Jul, 2019

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: 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)

placebo comparator: 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)

Interventions

Captopril

25mg Captopril

placebo

placebo

Primary outcome measure

  • Change in ophthalmic artery blood flow from baseline [ Time Frame: 1 hour post drug, 2 hours post drug, 3 hours post drug ]

Central Contacts and Locations

Central contacts

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

617-732-6901ebarkoudah@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 1, 2019

Last verified

Jul, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2019-08-01.