A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients (PILCHARDUS)

Inclusion Criteria:

• Age > 40 years and < 85
• BMI ≥ 25 and < 35
• Patients diagnosed with type 2 diabetes at onset or treated only by diet
• HbA1c between 6.0 and 8.0% (based on the last measured and documented laboratory measurement of the previous 3 months)
• Usual consumption ≤ 3 fish per week

Exclusion Criteria:

• T2D treated with antidiabetic oral drugs and/or insulin
• Current or previous (within 3 months) intake of omega 3 suplements
• Known allergy or intolerance to fish or fish protein
• Diagnosis of active neoplasic disease
• Suffering from an acute illness which requires a recovery period higher than one week
• Currently chronic treatment with oral steroids or nonesteroidal anti-inflammatory for more than 5 days, at least 1 month before randomization
• Pregnant or breast-feeding patients
• Serious acute vascular events (cardiac or cerebral) diagnosed previous 2 months before the randomization
• Current or previous (within 6 months) participation in another study
• Chronic renal insufficiency (creatinine >1,5 mg/dl)
• Any conditions that the investigator considers may render the patient unable to complete the study

During the interventional study, based on current standards of T2D care, doctors will introduce anti-diabetic oral drugs or insulin into the patient's treatment, where they consider it to be necessary.