Trial intelligence / Profile preview

Melatonin and Sleep Extension for Renal Physiology (MAST)

NCT02631148Phase 2

Key facts

Status: Terminated
Start: Jan 2016
Primary completion: Dec 2017
Countries: 1
Sponsor: Brigham and Women's Hospital
Modality: Small Molecules

Drugs: melatonin
Conditions: obesityprediabetes

Overview

Phase 2, randomised, double-blind trial in obesity and prediabetes comparing Melatonin Arm with Placebo Arm (2 arms). Primary endpoints: Change in Renal Specific Renin-aldosterone-angiotensin System Activity at 6 weeks and Change in Systemic Renin-aldosterone-angiotensin System Activity at 6 weeks. Started Jan 2016; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Melatonin Arm
2mg controlled-release melatonin nightly + sleep extension
Placebo Arm
Placebo nightly + sleep extension

Who it enrols

Obese individuals with pre-diabetes and habitual sleep restriction (<7 hours/night) who are able to extend sleep by one hour.

Endpoints

Primary

Change in Renal Specific Renin-aldosterone-angiotensin System Activity6 weeks
Change in Systemic Renin-aldosterone-angiotensin System Activity6 weeks

Secondary

Change in Glucose Metabolism6 weeks
Change in Central Blood Pressure6 weeks
Change in Nocturnal Blood Pressure6 weeks

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