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The VALIDATE-D Study (VALIDATE-D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01635062
First received: July 2, 2012
Last updated: February 28, 2017
Last verified: February 2017

July 2, 2012
February 28, 2017
September 2012
December 2015   (Final data collection date for primary outcome measure)
The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy [ Time Frame: baseline and 2 weeks following calcitriol/placebo therapy ]
The below results represent the change in Plasma Renin Activity.
Circulating RAS activity after calcitriol/placebo therapy
Complete list of historical versions of study NCT01635062 on ClinicalTrials.gov Archive Site
  • Change in Renal Plasma Flow After Calcitriol/Placebo Therapy [ Time Frame: baseline and 3 weeks following calcitriol/placebo therapy ]
    Subjects had their renal plasma flow assessed at baseline while sodium loaded, and again after 3 weeks of randomized therapy with either calcitriol (up to 0.75 mcg daily) or placebo.
  • Change in Urine Protein After Calcitriol/Placebo Therapy [ Time Frame: baseline and 3 weeks following calcitriol/placebo therapy ]
    Subjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo.
  • Renal-vascular tissue RAS activity after calcitriol/placebo therapy
  • Renal-vascular RAS activity after calcitriol/lisinopril therapy
Not Provided
Not Provided
 
The VALIDATE-D Study
Evaluating Hormonal Mechanisms for Vitamin D Receptor Agonist Therapy in Diabetes: The VALIDATE-D Study
The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.

This study aims to evaluate whether vitamin D receptor agonist therapy (calcitriol) in diabetes lowers renin-angiotensin system (RAS) activity in a manner similar to an ACE inhibitor. This is a physiology study, focused on evaluating hormonal changes in the circulating and tissue RAS when compared to placebo.

Subjects with type 2 diabetes and obesity and normal kidney function will undergo evaluation of their circulating and renal-vascular RAS activity and urinary protein at baseline, after withdrawing interfering medications, while on a controlled electrolyte diet, and in controlled posture settings. They will then randomly receive a study medication (calcitriol or placebo) for 3 weeks followed by a re-assessment of their RAS parameters. The main outcomes that will be evaluated following calcitriol/placebo include measures of the circulating renin activity (primary), as well as measures of the renal-vascular RAS (renal plasma flow) and urine protein (secondary)

The primary outcome is the change in the plasma renin activity when sodium restricted, before and after intervention. Secondary outcomes include the change in renal plasma flow and urine protein when sodium loaded, before and after intervention.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
  • Type 2 Diabetes
  • Obesity
  • Drug: Calcitriol
    Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.
    Other Name: 1,25-dihydroxyvitamin D3
  • Drug: Placebo
    Subjects will receive placebo for 3 weeks.
  • Experimental: calcitriol
    Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
    Intervention: Drug: Calcitriol
  • Placebo Comparator: placebo
    Subjects will receive placebo for 3 weeks.
    Intervention: Drug: Placebo
Brown JM, Secinaro K, Williams JS, Vaidya A. Evaluating hormonal mechanisms of vitamin D receptor agonist therapy in diabetic kidney disease: the VALIDATE-D study. BMC Endocr Disord. 2013 Aug 23;13:33. doi: 10.1186/1472-6823-13-33.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01635062
2012P000905
Yes
Not Provided
Not Provided
Not Provided
Anand Vaidya, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Anand Vaidya, MD, MMSc Brigham and Women's Hospital, Harvard Medical School
Brigham and Women's Hospital
February 2017

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