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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626469
First Posted: June 22, 2012
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
June 19, 2012
June 22, 2012
October 26, 2017
May 2012
January 31, 2019   (Final data collection date for 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 ]
Eye blood flow will be measured at baseline and post drug time points (3 total)
Change in ophthalmic artery blood flow from baseline [ Time Frame: 1 hour post drug, 3 hours post drug, 5 hours post drug ]
Complete list of historical versions of study NCT01626469 on ClinicalTrials.gov Archive Site
  • Change in blood pressure from baseline [ Time Frame: 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 [ Time Frame: 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)
Not Provided
Not Provided
Not Provided
 
Measurement of Eye Blood Flow and Renal Function in Healthy and Diabetic Patients
Eye Blood Flow and the Kidney
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: Captopril
    25mg Captopril
  • Drug: placebo
    placebo
  • 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)
    Interventions:
    • Drug: Captopril
    • Drug: placebo
  • 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:
    • Drug: Captopril
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
January 31, 2019
January 31, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01626469
2011P002805
No
Not Provided
Not Provided
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
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
Brigham and Women's Hospital
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP