The VALDIATE-D Study (VALIDATE-D)

This study is currently recruiting participants.
Verified January 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01635062
First received: July 2, 2012
Last updated: January 16, 2014
Last verified: January 2014

July 2, 2012
January 16, 2014
September 2012
September 2017   (final data collection date for primary outcome measure)
Circulating RAS activity after calcitriol/placebo therapy [ Time Frame: before 2017 ] [ Designated as safety issue: No ]
Circulating RAS activity after calcitriol/placebo therapy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01635062 on ClinicalTrials.gov Archive Site
  • Renal-vascular tissue RAS activity after calcitriol/placebo therapy [ Time Frame: before 2017 ] [ Designated as safety issue: No ]
  • Renal-vascular RAS activity and urien protein after calcitriol/lisinopril therapy [ Time Frame: before 2017 ] [ Designated as safety issue: No ]
  • Adiponectin levels [ Time Frame: Before 2017 ] [ Designated as safety issue: No ]
  • Adipose-tissue RAS measures [ Time Frame: before 2017 ] [ Designated as safety issue: No ]
  • Renal-vascular tissue RAS activity after calcitriol/placebo therapy [ Designated as safety issue: No ]
  • Renal-vascular RAS activity after calcitriol/lisinopril therapy [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The VALDIATE-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 a re-assessment of their RAS parameters. The main outcomes that will be evaluated following calcitriol/placebo include measures of the circulating RAS (primary), as well as measures of the renal-vascular RAS, urine protein, adipocytokine levels, and adipose-tissue RAS activity (secondary)

In an extension phase, Lisinopril will be added to the study drug for another 2 weeks followed by another assessment of the primary and secondary outcome parameters, and subjects will continue lisinopril+study drug for 3 additional months for one final assessment of RAS parameters and urinary protein.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Type 2 Diabetes
  • Obesity
  • Drug: Calcitriol and Lisinopril
    Subjects will receive calcitriol and lisinopril to evaluate their influence on the renin-angiotensin system when compared to placebo.
  • Drug: Placebo
    Placebo will be given
  • Active Comparator: calcitriol
    Subjects will receive calcitriol
    Intervention: Drug: Calcitriol and Lisinopril
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
September 2017   (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
Both
18 Years to 70 Years
No
Contact: Kristina Secinaro, RD 617-278-0305
Contact: Anand Vaidya, MD, MMSc 617-525-8285
United States
 
NCT01635062
2012P000905
Yes
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
January 2014

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