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

Study Overview
=================
Brief Summary
-----------------
Work hypothesis A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.

Official Title
-----------------
PILCHARDUS STUDY: A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Sardine diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sardine diet<br>Subjects follow general dietary recommendations for diabetes including a fixed amount of sardine in daily meals (100g per day, 5 days a week) as part of their usual diet. | Other: Sardine diet<br>* Diet rich in sardine: 100g/day of sardine 5 times a week<br>|
| No Intervention: Control diet<br>Subjects only follow general dietary recommendations for diabetes. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in adiponectin 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 | 
| 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 specific bacterial groups of gut microbiota 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sardine, Diet, Type 2 diabetes