Observational analysis of glycaemic, dietary and GPS data of Team Novo Nordisk Professional cyclists during a training camp
- Conditions
- E10Type 1 diabetes mellitus
- Registration Number
- DRKS00019923
- Lead Sponsor
- Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), A111 Engineering East, Fabian Way, Crymlyn Burrows
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 16
Informed consent obtained
- Male aged 18-65 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically)
- Treated with multiple daily insulin injections = 12 months
- Receipt of any investigational medicinal product within 1 month prior to screening in this trial
- Haemoglobin <8.0 mmol/L (male)
- Systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone and non-routine vitamins and herbal products. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
- Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full re-mission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted through-out the run of the trial. Furthermore, it does not exclude patients how have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten-free diet.
- Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time
- Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening Visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives
- Clinically significant abnormal ECG issues, as judged by the Medical Team
- Severe retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Medical Team
- Any chronic disorder or severe disease which, in the opinion of the Medical Team might jeopardise participant’s safety or compliance with the protocol
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- Significant history of alcoholism or drug/chemical abuse as per Investigator’s judgement or a positive result in the urine drug/alcohol screen at the screening Visit.
- Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking or use of nicotine substitute products during the monitoring period.
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event requiring assistance during the past 6 months)
- Hypoglycaemic unawareness as judged by the Medical Team or hospitalisation for diabetic ketoacidosis during the previous 6 months
- Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Medical Team, should not participate in the trial
- Potentially non-compliant or uncooperative during the trial, as judged by the Medical Team
- Any condition that would interfere with trial participation or evaluation of results, as judged by the Medical Team
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The endpoints of this study are the characterisation of:<br>- Glycemic variables<br>- Dietary intake<br>- Insulin amounts and timing<br>- Physical exercise and heart rate during cycling sessions
- Secondary Outcome Measures
Name Time Method