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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT02497651
Eligibility Criteria:
Inclusion Criteria:
* Both groups
* Caucasian ethnicity
* Healthy males
* Normal haemoglobin
* Age above 18 years
* Informed and written consent
* BMI \>20 kg/m2
Smokers • Minimum 20 cigarettes pr. day for at least 1 year
Non-smokers
• No smoking on a regular basis
Exclusion Criteria:
* Both groups
* Diabetes or prediabetes (fasting plasma glucose levels \>6.5 mM or HbA1c \>6.0%)
* First- or second-degree relatives with diabetes
* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Hypo- or hyperphosphataemia
* Nephropathy (serum creatinine \>150 µM and/or albuminuria
* Treatment with medicine that cannot be paused for 12 hours
* Hypo- or hypercalcaemia
* Hypo- and hyperthyroidism
* Treatment with oral anticoagulants
* Active or recent malignant disease
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Any condition considered incompatible with participation by the investigators
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02497651
Study Brief:
Protocol Section:
NCT02497651