Eye Blood Flow and the Kidney

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Norman K. Hollenberg, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01626469
First received: June 19, 2012
Last updated: March 30, 2015
Last verified: March 2015

June 19, 2012
March 30, 2015
May 2012
November 2015   (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 ] [ Designated as safety issue: No ]
Change in ophthalmic artery blood flow from baseline [ Time Frame: 1 hour post drug, 3 hours post drug, 5 hours post drug ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01626469 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Eye Blood Flow and the Kidney
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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: Captopril
    25mg Captopril
    Other Name: Captopril
  • Drug: placebo
    placebo
    Other Name: 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.
 
Recruiting
24
December 2015
November 2015   (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
Both
18 Years to 75 Years
No
Contact: Ebrahim Barkoudah, M.D.,M.P.H. 617-732-6901 ebarkoudah@partners.org
United States
 
NCT01626469
2011P002805
No
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
March 2015

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