Overview

The VALIDATE-D Study

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brigham and Women's Hospital
Treatments:
Calcitriol
Dihydroxycholecalciferols
Lisinopril
Criteria
Inclusion Criteria:

1. Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a
single injection of basal insulin daily)

2. Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or
adequately treated with a single anti-hypertensive drug.

3. Age >18 years and <70 years

4. Estimated GFR > 60ml/min

5. Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver
enzymes, urinalysis

6. Electrocardiogram without any signs of prior infarction, ventricular conduction
abnormality, or supraventricular arrhythmia.

Exclusion Criteria:

1. Chronic Kidney Disease or eGFR<60

2. History of nephrolithiasis (kidney stones)

3. Multiple (more than one) insulin injections daily (since insulin can alter the RAS)

4. Poorly controlled type 2 diabetes (That may require more aggressive therapy) as
defined by an HbA1c>8.5%

5. Type 1 diabetes

6. Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug

7. Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that
are treated with prescribed doses of NSAIDs by a physician.

8. The use of prescribed doses of potassium supplements.

9. History of liver failure

10. History of parathyroid or granulomatous disorders

11. History of heart failure, cerebrovascular disease or coronary heart disease

12. History of known microvascular complications of diabetes (including retinopathy,
neuropathy, nephropathy)

13. Illness requiring overnight hospitalization in the past 6 months

14. Active tobacco or recreational drug use

15. Pregnancy or current breast feeding