Status:
COMPLETED
A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
Work hypothesis A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02294526
Start Date
November 1 2012
End Date
November 1 2013
Last Update
January 29 2015
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