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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06757751
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with type 2 diabetes mellitus for at least 1 year prior to inclusion.
* Older than 18 years old
* Current treatment with diet and/or oral hypoglycemic agents (biguanides, thiazolindiones, α-glucosidase inhibitors, iDPP4, aGLP-1, iSGLT2).
* Body mass index ≥ 25 kg/m2 and \< 40 kg/ m2.
Exclusion Criteria:
* Patients on treatment with insulin, SU or rapid-acting insulin secretagogues.
* History of severe ketosis or hyperglycemic decompensation.
* Pregnancy, pregnancy planning or breastfeeding.
* Body mass index ≥ 25 kg/m2 and \< 40 kg/m2.
* Difficulty or great inconvenience in changing eating habits or a low predicted probability of changing eating habits.
* Serious medical condition that may affect the person's ability to participate in a nutritional intervention study (e.g., digestive disease with fat intolerance, malignant disease, or significant neurological, psychiatric, or endocrine disease).
* Any other medical condition considered to limit survival to less than 1 year.
* Immunodeficiency or HIV positive status.
* Illegal drug use, chronic alcoholism or problematic alcohol use or total daily alcohol intake \> 80 g/d.
* Participation in any clinical trial or use of any investigational drug within the past year.
* Patients institutionalized for chronic care.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06757751
Study Brief:
Protocol Section:
NCT06757751