type 1 diabetes
Conditions
Interventions
Group 1: Screening Visit: anamnesis, body impedance analysis, blood sampling, blood pressure measurement, 12-channel ECG analysis, written patient consent
Visit 2-6: Laboratory visit with monitoring o
Sponsors
BaySpo, Sportwissenschaften IV - Exercise Physiology and Metabolism, Universität Bayreuth
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Informed consent obtained from participants • Male or female aged 18-65 years (both inclusive) • Diagnosis of T1D for at least 2 years • Fasting C-peptide 60% during the last 4 weeks prior to study enrolment • Stable and sufficient basal rate during the last 4 weeks as judged by the investigator in charge • HbA1c < 7,5% at screening
Exclusion criteria
Exclusion criteria: • Enrolement in another study • Hypoglycemic unawareness via gold score • Previous clinically relevant hypoglycaemia or diabetic ketoacidosis requiring third party help during the last 6 months • 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 • Suffering 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 with T1D or patients taking medications that influence the metabolism (e.g. statin) 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. Furthermore, it does not exclude patients who have celiac disease (or similar diseases or allergies), as long as the disease is stable and participants do not require specific medication (e.g. cortisone), and patients are able to stay on their specific (e.g.) gluten-free diet • Participant with a heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position) • Supine systolic or diastolic blood pressure at screening (after resting for 5 min in supine position) over 150 mmHg (hypertension threshold; 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 (other than T1D) which, in the opinion of the investigator, might jeopardize participant’s safety or compliance with the protocol • History of any major cardiovascular disease or cancer • History of previous systemic GC-therapy lasting for more than 1 week • History of bone disease (e.g. osteoporosis, osteopenia, Mb. Paget) • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction • Participants with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, are not able to meet the cognitive or language requirements of the study • Potentially non-compliant or uncooperative participants, as judged by the Investigator • Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator • Female participants of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or who are not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner; assessed at screening in a personal conversation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective To determine the insulin infusion rate during the following 24 hours assessed by the AID system in response to the oral administration of each of following agents: prednisolone 10 mg, prednisolone 20 mg, dexamethasone 1,5 mg, dexamethasone 3 mg and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Venous blood samples for determination of cortisol, ACTH and lipid profiles will be taken at baseline as well as 120, 240, 360 and 480 minutes after administration of the specific tablet. In addition, capillary blood glucose measurements will be taken every 60 minutes and measured by a standardized laboratory device (Biosen C-line; EKF diagnostics) to assess sensor accuracy. | — |
Countries
Germany
Contacts
Public ContactOthmar Moser
BaySpo, Sportwissenschaften IV - Exercise Physiology and Metabolism, Universität Bayreuth
Outcome results
None listed