Exercise and blood glucose levels in patients with type I Diabetes

Conditions: Type 1 diabetes
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2013-004631-77-AT

Lead Sponsor: Medizinische Universität Graz/Endokrinologie und Stoffwechsel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

•Subjects must give their signed and dated informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
•Male subjects with type 1 diabetes with duration =12 month
•Age = 18 to = 35 years, both inclusive
•HbA1c = 64 mmol/mol
•Fasting C-peptide negative (= 0.3 nmol/l)
•Treatment with intensified insulin therapy or insulin pump therapy
•No diabetic long term complications
•No other physical and/or mental disease

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous participation (randomisation) in this trial
•History of any illness or disease that, in the opinion of the Investigator might confound the results of the trial
•Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilisation, or recovery from hypoglycemia
•Current addiction to alcohol or substances of abuse as determined by the investigator
•Known or suspected allergy to trial products or related products
•Any condition that the investigator feels would interfere with the trial participation or evaluation of data

Testing day inclusion criteria:
•48h before testing no hypoglycemia
•24h before testing no alcohol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the present study is to aoid hypoglycemia during and after testing and therefor to calculate a critical time by a pre exercise standardized insulin regimen during standardized cycle ergometer exercises dependent on different modes, intensity, duration and energy expenditure as well as counter regulatory hormones. ;Secondary Objective: Not applicable;Primary end point(s): As a hypothesis we expect no hypoglycemia during the cycle ergometer exercises dependent on an standardized pre exercise standardized insulin regimen in relation to the intensity, duration and the energy expenditure of the exercise and no post exercise hypoglycemia.;Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures