The VALDIATE-D Study (VALIDATE-D)
The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Evaluating Hormonal Mechanisms for Vitamin D Receptor Agonist Therapy in Diabetes: The VALIDATE-D Study|
- Circulating RAS activity after calcitriol/placebo therapy [ Time Frame: before 2017 ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Subjects will receive calcitriol
Drug: Calcitriol and Lisinopril
Subjects will receive calcitriol and lisinopril to evaluate their influence on the renin-angiotensin system when compared to placebo.
Placebo Comparator: placebo
Placebo will be given
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635062
|Contact: Molly Connors||617-732-5186|
|Contact: Anand Vaidya, MD, MMSc||617-525-8285|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Anand Vaidya, MD, MMSc||Brigham and Women's Hospital, Harvard Medical School|