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

Show full item record



Permalink

http://hdl.handle.net/10138/316233

Citation

e-PREDICE Consortium , Gabriel , R , Lindström , J & Tuomilehto , J 2020 , ' Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data ' , PLoS One , vol. 15 , no. 4 , 0231196 . https://doi.org/10.1371/journal.pone.0231196

Title: Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data
Author: e-PREDICE Consortium; Gabriel, Rafael; Lindström, Jaana; Tuomilehto, Jaakko
Contributor: University of Helsinki, Clinicum
Date: 2020-04-13
Language: eng
Number of pages: 23
Belongs to series: PLoS One
ISSN: 1932-6203
URI: http://hdl.handle.net/10138/316233
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). Drug intervention will last 2 years. Primary Outcome: composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index. Secondary outcomes in a subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function. Results One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin. A total of 809 people (91.1%) accepted and initiated the assigned treatment. Study sample after randomization was well balanced among the four groups. No statistical differences for the main risk factors analysed were observed between those accepting or rejecting treatment initiation. At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%. Conclusions ePREDICE is the first -randomized clinical trial with the aim to assess effects of different interventions (lifestyle and pharmacological) on microvascular function in people with pre-diabetes. The trial will provide novel data on lifestyle modification combined with glucose lowering drugs for the prevention of early microvascular complications and diabetes. Registration - ClinicalTrials.Gov Identifier: NCT03222765 - EUDRACT Registry Number: 2013-000418-39
Subject: 3121 Internal medicine
IMPAIRED FASTING GLUCOSE
LIFE-STYLE INTERVENTION
CARDIOVASCULAR EVENTS
RISK-FACTORS
FOLLOW-UP
TOLERANCE
MORTALITY
MELLITUS
WEIGHT
SCORE
Rights:


Files in this item

Total number of downloads: Loading...

Files Size Format View
journal.pone.0231196.pdf 1.099Mb PDF View/Open

This item appears in the following Collection(s)

Show full item record