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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT05495451
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* Ability to give written consent, to use a smartphone application or complete an adherence/compliance diary, and use a blood glucose and blood pressure machine at home.
Exclusion Criteria:
* All types of diabetes other than type 2
* Taking the following glucose-lowering agents: insulin, sulfonylureas
* BMI \< 18,5 kg/m2
* Unintentional weight loss of more than 10 kg in the past year
* Moderate to severe retinopathy
* Pregnant or nursing woman
* Severe organ failure
* Pathologies predisposing to gastrointestinal bleeding, untreated
* Recent cholecystitis (3 months)
* Antibiotic use in the past 3 months, or untreated active infection
* Known impaired nutrient absorption
* Uninvestigated new anemia or Hb \< 110 g/100 mL
* Currently following an intermittent or prolonged fasting protocol
* Currently following a specific diet (vegan, celiac/gluten free, ketogenic)
* Active diagnoses of psychiatric or neurological illness not controlled for at least 6 months
* Taking, stopping or adjusting a medication in the last 3 months resulting in an active weight change.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05495451
Study Brief:
Protocol Section:
NCT05495451