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

Type 2 Diabetes Clinical Trial

— PILCHARDUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294526
• Other study ID #: CIBERDEM-PILCHARDUS
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: January 28, 2015
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Work hypothesis

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Sardine diet
Diet rich in sardine: 100g/day of sardine 5 times a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycated hemoglobin (HbA1c) at 6 months		Baseline and 6 months	Yes
Primary	Change from baseline in fasting glucose at 6 months		Baseline and 6 months	Yes
Primary	Change from baseline in fasting insulin at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in adiponectin at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in leptin at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in ultra sensitive C-reactive protein (us-CRP) at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in interleukin-6 (IL-6) at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in interleukin-8 (IL-8) at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in interleukin-10 (IL-10) at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in tumor necrosis factor alpha (TNFa) at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in erytrocite membrane fatty acid composition (EMFA) at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in specific bacterial groups of gut microbiota at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in total cholesterol at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in LDL cholesterol at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in HDL cholesterol at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in triglycerides at 6 months		Baseline and 6 months	Yes
Secondary	Change from baseline in blood pressure at 6 months		Baseline and 6 months	Yes