NCT02294526

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
Last Updated

January 29, 2015

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

October 31, 2014

Last Update Submit

January 28, 2015

Conditions

Type 2 Diabetes

Keywords

DietSardineType 2 diabetes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (2)

Sardine diet

EXPERIMENTAL

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

Control diet

NO INTERVENTION

Subjects only follow general dietary recommendations for diabetes.

Interventions

Sardine dietOTHER

Diet rich in sardine: 100g/day of sardine 5 times a week

Sardine diet

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27090218DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ramon Gomis, Professor

    CIBERDEM - IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer) - Hospital Clínic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 19, 2014

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 29, 2015

Record last verified: 2014-11