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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT04449120
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 2 Diabetes Mellitus without treatment with insulin, sulfonylureas and glinides.
* Overweight or obesity (BMI between 25 and 40 kg/m2).
* Stable treatment with oral antidiabetics, other than sulfonylureas or glinides, at least for 3 months.
Exclusion Criteria:
* Treatment with insulin, sulfonylureas or glinides
* Glycosylated hemoglobin (HbA1c) concentration greater than 10%
* Weight loss exceeding 5 kg in the past three months
* Pregnant or breastfeeding women
* Serious medical condition that impedes from conducting the dietary intervention or that limits the survival to less than one year
* Consumption of illegal drugs, chronic alcoholism or alcohol total consumption above 80 g/day
* Participation in other clinical trial with drugs or nutritional intervention during the previous year to inclusion
* Major difficulties or inconveniences in changing dietary habits and following the Mediterranean Diet (allergies, intolerances)
* Difficulties for regular home cooking and/or eating out more than 2 days per week
* Current diagnosis of an eating disorder, schizophrenia, other psychotic disorder or bipolar disorder
* Hospitalization for any mental illness in the previous year
* History of bariatric surgery or extensive bowel resection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04449120
Study Brief:
Protocol Section:
NCT04449120