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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT01610934
Eligibility Criteria:
Inclusion Criteria:
* Caucasian above 18 years of age
* Well characterised MODY3
* Body mass index (BMI) \> 19 kg/m2
* Normal haemoglobin (males \> 8.2 mM, females \> 7.2 mM)
* Normal blood pressure (\< 160/100 mmHg)
* Informed consent
* Capability to perform a light cycling test (heart rate 100-120 beats per minute during 30 minutes)
* Females: use of anticonception (IUC or hormonal)
Exclusion Criteria:
* Heart failure: New York Heart Association class III-IV
* Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine \> 130 µM and/or albuminuria
* Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) \> 2 × upper normal serum levels)
* Anaemia
* Acute or chronic pancreatitis
* Stroma or thyroid cancer
* Pregnancy or breast feeding
* Inability to complete the study
* Treatment naïve patients with HbA1c \< 7.0 %
* Treatment with medicine that can not be paused for 12 hours
* Known allergic reaction to study medication
* Intention to become pregnant
* Unwillingness to complete the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01610934
Study Brief:
Protocol Section:
NCT01610934