Status:
COMPLETED
Caffeine Ingestion to Counter the Exercise-mediated Fall in Glycaemia in Type 1 Diabetes
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Caffeine and Carbohydrate
Carbohydrate Only
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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 d...
Detailed Description
Treatment of type 1 diabetes (T1D) involves lifelong use of exogenous insulin to manage blood glucose concentration. As with the rest of the population, people living with T1D are recommended to engag...
Eligibility Criteria
Inclusion
- 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
- 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 defined by area under the curve \>30 mg/g)
- Body mass index more than or equal to 30 kg/m2
- Uncontrolled hypertension (\>180/100 mmHg)
- Pregnant or planning to become pregnant during the study period (females only)
- Breastfeeding
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04671043
Start Date
February 4 2022
End Date
February 2 2023
Last Update
March 14 2023
Active Locations (1)
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1
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
Bern, Switzerland, 3010