Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants with type 2 diabetes mellitus will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups for 12 weeks. Randomisation will be stratified by sex and baseline HbA1c
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Men or women aged between 40 and 70 years 2. Diagnosis of type 2 diabetes mellitus established according to the criteria of the American Diabetes Association (ADA) 3. Excess body fat (preclinical or clinical obesity, according to the definition and diagnostic criteria for clinical obesity established by the 2025 Lancet Diabetes & Endocrinology Commission) determined by direct body fat measurement (DEXA scan) or fulfillment of at least two of the following criteria: 3.1. BMI = 25 kg/m² 3.2. Waist circumference = 102 cm for men or = 88 cm for women 3.3. Waist-to-hip ratio > 0.90 for men or > 0.85 for women 3.4. Waist-to-height ratio > 0.5 for all participants 3.5. Excess body fat will be pragmatically assumed if BMI is > 40 kg/m². 4. Stable pharmacological treatment for T2DM for at least 3 or 6 months prior to inclusion, which may include: 4.1. Metformin (3 months) 4.2. DPP-4 inhibitors (3 months) 4.3. SGLT2 inhibitors (6 months) 4.4. GLP-1 receptor agonists (6 months) 5. Stable statin treatment, when indicated 6. Ability to understand the study information and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Active chronic inflammatory diseases, such as Crohn's Disease, Ulcerative Colitis, inflammatory arthritis, or other systemic inflammatory disorders 2. Chronic treatment with nonsteroidal anti-inflammatory drugs or systemic corticosteroids within the previous 6 months. 3. Habitual consumption of meals outside the home three or more times per week, which would hinder adequate control of the dietary intervention 4. Use of hormonal contraceptives, pregnancy, breastfeeding, or steroid hormone replacement therapy 5. Current diagnosis of malignant neoplasia or history of neoplasia within the year prior to inclusion 6. Active smoking or former smokers with less than 5 years of abstinence 7. Having been born and having lived for most of the first 18 years of life (more than 10 years during the first 18 years) in countries not aligned with the traditional Mediterranean diet (countries other than Spain, Italy, Greece, Southern France [Provence-Alpes-Côte d’Azur region and the departments of Hérault, Gard, Aude, and Pyrénées-Orientales in the Occitanie region], Portugal, Croatia [Dalmatian Coast], Albania, Turkey [Aegean Coast], Lebanon, Israel, Morocco, and Tunisia) 8. Objective inability to comply with study procedures, defined as the presence of significant cognitive impairment, substantial language barriers, logistical inability to attend scheduled visits, anticipated major therapeutic changes during the intervention period, or any other documented circumstance preventing adequate compliance with the intervention and data collection, as appropriately recorded in the study records
Countries
Spain
Contacts
Public ContactFrancisco-Javier Bermudez-Silva
Outcome results
None listed