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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT05615558
Eligibility Criteria:
Inclusion Criteria:
* Aged 40-70 y
* Body-mass index of 27-45 kg/m2
* Diagnosed with T2D with their most recent HbA1c value greater than 6.0% (\>43 mmol/mol) and receiving dietary advice and/or antidiabetic medication (metformin, DPP-4 inhibitors only).
* Males and females
Exclusion Criteria:
* Habitual dietary intake of \<0.6 or \>1.2 g/kg/day protein (determined from dietary history interview given at screening)
* Current use of insulin
* HbA1c of 12% or more (≥108 mmol/mol)
* Weight loss of more than 5 kg within the past 6 months
* A recent estimated glomerular filtration rate (eGFR) of less than 30 mL/min,
* Heart failure,
* Participation in another clinical research trial, substance abuse, known cancer, myocardial infarction within the previous 6 months, current treatment with anti-obesity drugs, pregnancy or consideration of pregnancy, and hospital admission for depression or use of antipsychotic drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT05615558
Study Brief:
Protocol Section:
NCT05615558