Clinical trial NCT02294526: A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients
Official title: PILCHARDUS STUDY: A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diet
Sardine
Type 2 diabetes
Lead sponsor: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Work hypothesis

A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.


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.

Primary outcomes:
measure: Change from baseline in glycated hemoglobin (HbA1c) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in fasting glucose at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in fasting insulin at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change from baseline in adiponectin at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in leptin at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in ultra sensitive C-reactive protein (us-CRP) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in interleukin-6 (IL-6) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in interleukin-8 (IL-8) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in interleukin-10 (IL-10) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in tumor necrosis factor alpha (TNFα) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in erytrocite membrane fatty acid composition (EMFA) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in specific bacterial groups of gut microbiota at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in total cholesterol at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in LDL cholesterol at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in HDL cholesterol at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in triglycerides at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in blood pressure at 6 months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: CIBERDEM - IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer) - Hospital Clínic of Barcelona
name: Ramon Gomis, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balfego M, Canivell S, Hanzu FA, Sala-Vila A, Martinez-Medina M, Murillo S, Mur T, Ruano EG, Linares F, Porras N, Valladares S, Fontalba M, Roura E, Novials A, Hernandez C, Aranda G, Siso-Almirall A, Rojo-Martinez G, Simo R, Gomis R. Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naive patients with type 2 diabetes: a pilot randomized trial. Lipids Health Dis. 2016 Apr 18;15:78. doi: 10.1186/s12944-016-0245-0.