Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data.

ABSTRACT:

Objectives

To assess the effects of early management of hyperglycaemia with antidiabetic drugs plus lifestyle intervention compared with lifestyle alone, on microvascular function in adults with pre-diabetes.

Methods

Trial design: International, multicenter, randomised, partially double-blind, placebo-controlled, clinical trial.

Participants

Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey.

Intervention

Participants were randomized to placebo; metformin 1.700 mg/day; linagliptin 5 mg/day or fixed-dose combination of linagliptin/metformin. All patients were enrolled in a lifestyle intervention program (diet and physical activity). Dru

SUBMITTER: Gabriel R 

PROVIDER: S-EPMC7153858 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature