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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | 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) |
|
| Captopril | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Captopril | Drug | 25mg Captopril |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure from baseline | Blood pressure will be monitored throughout the study starting at baseline | Every 15 minutes for 3 hours |
| Change in renal plasma flow (RPF) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ebrahim Barkoudah, M.D.,M.P.H. | Contact | 617-732-6901 | ebarkoudah@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Norman K Hollenberg, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Ebrahim Barkoudah, M.D.,M.P.H. | Brigham and Women's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002216 | Captopril |
| ID | Term |
|---|---|
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| Drug |
placebo |
|
Renal Plasma Flow (to measure kidney function) will be measured at baseline and post drug time points (3 total)
| 1 hour post drug, 2 hours post drug, 3 hours post drug |
| D004700 | Endocrine System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |