Caffeine Ingestion to Counter the Exercise-mediated Fall in Glycaemia in Type 1 Diabetes (NCT04671043) | Clinical Trial Compass
CompletedNot Applicable
Caffeine Ingestion to Counter the Exercise-mediated Fall in Glycaemia in Type 1 Diabetes
Switzerland21 participantsStarted 2022-02-04
Plain-language summary
This project will aim to investigate the clinical efficacy and metabolic effects of a pre-exercise dose of caffeine with a low (10g) dose of carbohydrate (CAF+lowCHO) without modification of insulin degludec on exercise metabolism in people with T1D.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Type 1 diabetes for ≥1 year and negative C-peptide (\<100pmol/l)
* Male and female aged 18-45 years old
* HbA1c \<8.5% (69 mmol/mol) based on analysis from the central laboratory unit of Bern University Hospital
* Using multiple daily injections
* Using insulin degludec (Tresiba; Novo Nordisk A/S, Bagsværd, Denmark) as basal insulin for a minimum of 3 months
* Written informed consent
* Able and willing to adhere to safe contraception during the study and for 2 weeks after completion of the study. Safe contraception comprises double barrier methods (hormonal contraception \[like: oral contraceptive pills or intrauterine contraceptive devices\] together with a mechanical barrier \[like: condom, diaphragm\]).
Exclusion Criteria:
* Physical or psychological disease likely to interfere with the normal conduct of the study as judged by the investigator
* Continuous subcutaneous insulin infusion (using an insulin pump)
* Hypoglycaemic unawareness (Gold likert score ≥4) or having experienced any episode of a severe hypoglycaemic event within the last 6 months (i.e. need of third-party assistance).
* Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, SGLT2 inhibitors, Glucagon like 1 peptide- receptor agonists, or metformin.
* Relevant diabetic complications as judged by the investigator and based on medical record check (no cardiovascular disease and no significant microvascular disease)
* Microalbuminuria (as defi…