The VALIDATE-D Study (VALIDATE-D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01635062|
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention|
Type 2 Diabetes
Subjects were recruited from the local Boston community
A total of 41 participants were consented to participate. Subsequently, 13 were found ineligible, 5 withdrew participation, 3 were lost-to follow-up, and 2 were withdrawn for non-compliance with the washout. Therefore, 18 were randomized.
An anti-hypertensive medication washout was conducted to minimize confounding of the renin-angiotensin system.
ACE inhibitors, angiotensin-receptor blockers, and mineralocorticoid receptor antagonists, beta blockers, diuretics, and calcium-channel blockers were withdrawn for 2 weeks to 2 months prior to randomization.