Type 2 Diabetes | The VALIDATE-D Study
Type 2 Diabetes research study
What is the primary objective of this study?
The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 2 Diabetes
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:CalcitriolSubjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.
Drug:PlaceboSubjects will receive placebo for 3 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
calcitriolSubjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
placeboSubjects will receive placebo for 3 weeks.
Start Date: September 2012
Completed Date: December 2015
Primary Outcome: The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy
Secondary Outcome: Change in Renal Plasma Flow After Calcitriol/Placebo Therapy
Study sponsors, principal investigator, and references
Principal Investigator: Anand Vaidya, MD, MMSc
Lead Sponsor: Brigham and Women's Hospital