The VALIDATE-D Study — VALIDATE-D  

Obesity Clinical Trial

Official title: Evaluating Hormonal Mechanisms for Vitamin D Receptor Agonist Therapy in Diabetes: The VALIDATE-D Study

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Type 2 Diabetes

• NCT number: NCT01635062
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Completion date: December 2015