Type 1 Diabetes
Conditions
Interventions
Group 1: Treadmill running (continuous endurance exercise) for 1 hour
Group 2: Treadmill running (interval running) for 60 minutes
Group 3: Cycling on an ergometer (continuous endurance exercise) for
Sponsors
Division Exercise Physiology and Metabolism
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Adults with type 1 diabetes mellitus (as diagnosed clinically) = 12 months - Treated with multiple daily injections = 12 months - Body mass index 18.0-29.4 kg/m2 (both inclusive) - Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min - HbA1c = 10% (86 mmol/mol) - Using a CGM/isCGM
Exclusion criteria
Exclusion criteria: - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the past 12 months) - Impaired awareness of hypoglycaemia as judged by the Investigator based on Gold Score (=4) - Hospitalisation for diabetic ketoacidosis during the previous 12 months. - Enrolment in other study - Known or suspected hypersensitivity to trial product(s) or related products - Receipt of any investigational medicinal product within 1 week prior to screening in this trial - Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission 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 and cardiopulmonary systems (e.g. insulin, oral antidiabetic medication, lipid lowering medication, medication referring heart failure) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. - Participant with a heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position) - Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 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 - Significant abnormal ECG at screening, as judged by the Investigator - Any chronic (metabolic) disorder or severe disease which, in the opinion of the Investigator 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 - Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial - Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator - Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until (min) first carbohydrate supplementation (BG =90 mg/dL) to prevent hypoglycaemia during metabolically matched cycle ergometer vs. treadmill exercise as continuous exercise session and high-intensity interval exercise sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare the amount of carbohydrates and frequency of carbohydrate supplementation needed to avoid hypoglycaemia (BG =90 mg/dL) during metabolically matched cycle ergometer vs. a treadmill exercise sessions - To compare the blood glucose response (BGdelta) following a 50% reduced prandial insulin dose during metabolically matched cycle ergometer vs. a treadmill cardio-pulmonary exercise test until volitional exhaustion - To compare the blood glucose response (BGdelta) following a 50% reduced prandial insulin dose during metabolically matched cycle ergometer vs. a treadmill continuous exercise session - To compare the blood glucose response (BGdelta) following a 50% reduced prandial insulin dose during metabolically matched cycle ergometer vs. a treadmill high-intensity interval exercise sessions - To compare number of hypoglycaemic (Hypoglycaemian) episodes during metabolically matched cycle ergometer vs. a treadmill exercise sessions - To compare time in prespecified glycaemic response (%time in range [%TIR]/ euglycaemia (3.9 - 10.0 mmol/L [70 - 180 mg/dL]); %time above range [%TAR]/ (= 10 mmol/L, [= 180 mg/dL]) and %time below range [%TBR]/ (= 3.9 mmol/L [< 70 mg/dL]) during metabolically matched - To compare hormonal changes prior to – and post cardio-pulmonary exercise testing until volitional exhaustion - To compare hormonal changes prior to- during and post-exercise during metabolically matched continuous and high-intensity interval exercise sessions on a cycle ergometer and on a treadmill - To compare changes in heart rate variability (HRV?), heart rate response (HRrep) and cardiac alterations in comparison before and after cycle ergometer vs. treadmill exercise sessions | — |
Countries
Germany
Contacts
Public ContactOthmar Moser
Division Exercise Physiology and Metabolism
Outcome results
None listed