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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01015794
Eligibility Criteria:
Inclusion Criteria: healthy group
* Males aged 20 - 40 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Fasting plasma glucose \< 6.1 mmol/L and 2 hour OGTT glucose \< 7.8 mmol/L
* Unmedicated
* No major illness
* BMI 18 - 25
Inclusion Criteria: obese group
* Males aged 20 - 40 years
* Free of overt coronary disease (on history, medical examination and ECG)
* Unmedicated
* No major illness
* BMI 30+
* Weight \< 100 kg
* Height \< 185 cm
The inclusion criteria (Obese participants) of body weight less than \~100 kg is implemented as the PET-CT scanner to be utilised (protocol described subsequently) has a limited patient volume. Therefore to fit within the criteria of BMI \> 30, only patients of height \~183 cm or less can be recruited, and inclusion of borderline participants will be discussed with co-investigators from the Alfred Hospital Nuclear Medicine Department.
Exclusion Criteria: healthy group
* Unable to give informed consent
* Smokers
* Lactose intolerance
Exclusion Criteria: obese group
* Unable to give informed consent
* Smokers
* Lactose intolerance
* Participant in research projects involving ionising radiation within the past 5 years
* claustrophobia
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT01015794
Study Brief:
Protocol Section:
NCT01015794