Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial).

ABSTRACT:

Introduction

The primary aim of this study is to compare the efficacy of three short-term glucose-lowering interventions (exercise, metformin and dapagliflozin) on glycaemic variability in overweight or obese men and women with elevated diabetes risk (ie, prediabetes, defined as haemoglobin A_1c (HbA_1c)39-47 mmol/mol / 5.7%-6.4%). The secondary aims are to investigate the effects of the interventions on body composition and cardiometabolic risk factors.

Methods and analysis

The Pre-D Trial is an investigator-initiated, randomised, controlled, parallel, open-label, superiority trial. The study aims to assign 120 participants in a 1:1:1:1 ratio to receive one of four interventions for 13 weeks: (1) dapagliflozin (10 mg once daily); (2) metformin (850 mg tw

SUBMITTER: Færch K 

PROVIDER: S-EPMC5734208 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature