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:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT01048268
Eligibility Criteria:
Inclusion Criteria:
* Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
* Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
* Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
* Normal hemoglobin
* Informed consent
Exclusion criteria:
* Unwillingness to participate or the wish to leave the present study
* HbA1c \> 9 %
* Liver disease (ALAT or ASAT \> 2 times normal value)
* Diabetic nephropathy (serum creatinin \> 130 microM and/or albuminury)
* Proliferative diabetic retinopathy (anamnetic)
* Atherosclerotic heart disease or heart failure (NYHA group III and IV)
* Anemia
* Treatment with medicine which cannot be paused for 12 hours
* Pregnancy and/or breast feeding
* Fasting plasma glucose \> 15 mM on the day of the experiment
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01048268
Study Brief:
Protocol Section:
NCT01048268