Prevention of diabetes through lifestyle intervention and population studies in Europe and around the world - Preview

niversiteit Maastricht0 sites203 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

March 8, 2018

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•Adults: age between 25 and 70;
•BMI \> 25kg/ m2;
•The criteria from IDF (International Diabetes Foundation) for assessing pre\-diabetes will be used as the formal inclusion criteria, i.e. having Impaired Fasting Glucose (IFG): Fasting venous
•plasma glucose concentration 5\.6\-6\.9 mmol/l or
•Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7\.8 \* 11\.0 mmol/l at
•2 h after oral administration of 75 g glucose (oral glucose tolerance
•test, OGTT).
•HOMA\-IR has to be \>\<\=2\.

•1\) Diabetes mellitus
•2\) Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease
•3\) Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months;
•4\) Advanced chronic renal impairment;
•5\) Significant liver disease e.g. cirrhosis (fatty liver disease allowed);
•6\) Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed);
•7\) Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsoption;
•8\) Previous bariatric surgery;
•9\) Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program);
•10\) A recent surgical procedure until after full convalescence (investigators judgement);