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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT05028803
Eligibility Criteria:
Inclusion Criteria:
* • Participant is willing and able to give informed consent for participation in the study
* Not currently taking any medications
* Males between the ages of 18 - 60
* BMI ≥ 30 kg·m2
* FBG ≥ 6 mmol/L ≤ 7mmol/L or HbA1c ≥ 42 mmol/mol 48 ≤ mmol/mol
Exclusion Criteria:
* • Specify any diseases/disorders/ conditions that would preclude entry into the study
* Females
* History or current psychiatric illness
* History or current neurological condition (e.g. epilepsy)
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)
* A BMI \< 30kg·m2
* FBG \>7mmol/L/ or HbA1c \>48mmol/mol
* Metabolic disease; Active inflammatory bowel disease
* Chronic kidney disease
* Malignancy
* Recent (6 mo) steroid/ hormone therapy
* Clotting dysfunction
* Musculoskeletal/ neurological disorders
* Active cardiovascular disease or recent cardiac event
* Respiratory disease (not including well-controlled asthma)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05028803
Study Brief:
Protocol Section:
NCT05028803