The VALIDATE-D Study

Completed · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes, Obesity

In brief

The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.

Key facts

Study ID

NCT01635062

Run by

Brigham and Women's Hospital

People needed

41

Starts

2012-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily)
• Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug.
• Age >18 years and <70 years
• Estimated GFR > 60ml/min
• Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis
• Electrocardiogram without any signs of prior infarction, ventricular conduction abnormality, or supraventricular arrhythmia.

You may not qualify if…

• Chronic Kidney Disease or eGFR<60
• History of nephrolithiasis (kidney stones)
• Multiple (more than one) insulin injections daily (since insulin can alter the RAS)
• Poorly controlled type 2 diabetes (That may require more aggressive therapy) as defined by an HbA1c>8.5%
• Type 1 diabetes
• Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
• Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs by a physician.
• The use of prescribed doses of potassium supplements.
• History of liver failure
• History of parathyroid or granulomatous disorders
• History of heart failure, cerebrovascular disease or coronary heart disease
• History of known microvascular complications of diabetes (including retinopathy, neuropathy, nephropathy)
• Illness requiring overnight hospitalization in the past 6 months
• Active tobacco or recreational drug use
• Pregnancy or current breast feeding

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.