Type 2 Diabetes
Conditions
Keywords
Diet, Sardine, Type 2 diabetes
Brief summary
Work hypothesis A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.
Interventions
OTHERSardine diet
Diet rich in sardine: 100g/day of sardine 5 times a week
Sponsors
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in glycated hemoglobin (HbA1c) at 6 months | Baseline and 6 months |
| Change from baseline in fasting glucose at 6 months | Baseline and 6 months |
| Change from baseline in fasting insulin at 6 months | Baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in interleukin-6 (IL-6) at 6 months | Baseline and 6 months |
| Change from baseline in interleukin-8 (IL-8) at 6 months | Baseline and 6 months |
| Change from baseline in interleukin-10 (IL-10) at 6 months | Baseline and 6 months |
| Change from baseline in tumor necrosis factor alpha (TNFα) at 6 months | Baseline and 6 months |
| Change from baseline in erytrocite membrane fatty acid composition (EMFA) at 6 months | Baseline and 6 months |
| Change from baseline in adiponectin at 6 months | Baseline and 6 months |
| Change from baseline in total cholesterol at 6 months | Baseline and 6 months |
| Change from baseline in LDL cholesterol at 6 months | Baseline and 6 months |
| Change from baseline in HDL cholesterol at 6 months | Baseline and 6 months |
| Change from baseline in triglycerides at 6 months | Baseline and 6 months |
| Change from baseline in blood pressure at 6 months | Baseline and 6 months |
| Change from baseline in specific bacterial groups of gut microbiota at 6 months | Baseline and 6 months |
| Change from baseline in leptin at 6 months | Baseline and 6 months |
| Change from baseline in ultra sensitive C-reactive protein (us-CRP) at 6 months | Baseline and 6 months |
Outcome results
None listed