Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02308293
Eligibility Criteria:
Inclusion criteria for healthy subjects
* Age: 18-40 years
* Body-Mass Index: 18-30 kg/m2
* Blood pressure: \<160/90 mmHg
* Recreationally active: i.e. taking part in competitive sport or regular exercise training, of a non-professional nature, once or more a week.
Inclusion criteria T1DM patients with normal hypoglycemic awareness
* Diabetes duration ≥ 1 year
* Age: 18-40 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: 0-1
* Blood pressure: \<160/90 mmHg
* Recreationally active: i.e. taking part in competitive sport or regular exercise training, of a non-professional nature, once or more a week
Inclusion criteria T1DM patients with hypoglycemia unawareness
* Diabetes duration ≥ 1 year
* Age: 18-40 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: =\>3
* Blood pressure: \<160/90 mmHg
* Recreationally active
Exclusion criteria:
* Inability to provide informed consent
* Presence of any medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders
* Use of any medication, except for oral contraceptives
* MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
* Orthopedic and/or neurological diseases that impair exercise
* Cardiopulmonary disease as stated in the 2001 American heart association and 2002 American college of cardiology/American heart association guidelines
Additional exclusion criteria for all T1DM patients:
* Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy
* complications of T1DM, including proliferative retinopathy, neuropathy or nephropathy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02308293
Study Brief:
Protocol Section:
NCT02308293