Chronotherapeutic lifestyle intervention for diabetes and obesity to reset the circadian rhythm and improve cardiometabolic risk in the European population - Chronotherapeutic Lifestyle Intervention for Diabetes (Eurhythdia)

niversity of Leeds0 sites160 target enrollmentAugust 11, 2014

Overview

No summary available.

Registry

who.int

Start Date

August 11, 2014

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity of Leeds

•Ability to understand and personally sign and date the informed consent form.
•Male and female subjects above the age of 18;
•At least one first degree relative with a confirmed diagnosis of type 2 diabetes
•No personal history of type 2 diabetes
•Absence of clinical symptoms and signs of infection
•Absence of systemic disease which may interfere with glucose metabolism.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 120

•subjects with diabetes on OGTT criteria at baseline will be excluded from study and referred to their primary care physician for advice
•Pregnancy or breast feeding;
•Illness that makes the subject unlikely to fully complete the study
•Evidence of relevant renal insufficiency as indicated by an estimated glomerular filtration rate below 50 ml/min/m2\.
•Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT, AST, GGT, alkaline phosphatase, or serum bilirubin (2\.5 fold above upper limit of reference range).
•Known or suspected intolerance or hypersensitivity to the study medication, closely related compounds, or any of the stated ingredients.
•Use of melatonin, fluvoxamine, cimetidine, quinolones, carbamazepine, rifampicine, 5\-methoxypsoralene or 8\-methoxypsoralene within 4 weeks prior to the inclusion into the study.
•Clinical symptoms and signs of infection
•Subjects who consume more than 750mg caffeine/day (7 regular cups)