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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07467967
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 years
* Type 2 diabetes diagnosed for at least one year
* Well-controlled diabetes on oral antidiabetic drugs for at least 3 months, with a target baseline HbA1c \< 8%
* Duration of diabetes \< 15 years
* Patient available for an 8-week period
* Written informed consent
Non-inclusion Criteria:
* Patients on insulin therapy
* Oral antidiabetic treatment modified within the 3 months prior to inclusion
* Diabetes with established microvascular or macrovascular complications
* Severe intercurrent diseases (severe renal insufficiency, severe liver disease, cardiovascular history, neoplasia, inflammatory disease)
* Pregnancy or breastfeeding
* Known allergy or intolerance to dates
* Dietary regimens incompatible with isocaloric substitution (e.g., strict ketogenic diet, prolonged fasting)
* Inability to understand or comply with study instructions (cognitive impairment, language barrier without interpreter, major logistical constraints)
Exclusion Criteria:
* Initiation of insulin therapy or major modification of antidiabetic treatment
* Occurrence of pregnancy during the study
* Development of a serious adverse event attributable to the intervention (e.g., persistent hyperglycemia, acute metabolic complications)
* Patient refusal to continue the study or withdrawal of informed consent
* Major non-adherence to the intervention (\<80% of planned intake or absence of isocaloric substitution)
* Detection of a severe intercurrent condition requiring discontinuation of the intervention (e.g., heart failure decompensation, severe infection)
* Loss to follow-up preventing the assessment of primary endpoints
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07467967
Study Brief:
Protocol Section:
NCT07467967