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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT06144593
Eligibility Criteria:
Inclusion Criteria:
* Men or women
* 35-75 years old
* BMI \>27 kg/m2
* Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c \>48 mmol/mol if no glucose lowering therapy
Exclusion Criteria:
* Anemia (hemoglobin \<8 mmol/L for men and \<7 mmol/L for women)
* TSH outside reference range
* Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
* Treatment with systemic corticosteroids
* HbA1c \>70 mmol/mol
* eGFR \<60 ml/min/1.73 m2
* Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
* Food allergies (including lactose and gluten intolerance)
* Vegetarian/vegan diet or following of specific dietary plans
* Alcohol consumptions \>84/168 g/week (women/men)
* Strenuous activity level \> 120 minutes per week
* Weight loss (\>5 kg) within the last three months or previous bariatric surgery
* High risk of fibrosis of the liver (estimated by FIB4 score \> 3.25)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT06144593
Study Brief:
Protocol Section:
NCT06144593