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Work hypothesis
A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control diet | No Intervention | Subjects only follow general dietary recommendations for diabetes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sardine diet | Other | Diet rich in sardine: 100g/day of sardine 5 times a week |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ramon Gomis, Professor | CIBERDEM - IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer) - Hospital Clínic of Barcelona | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27090218 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D004700 | Endocrine System Diseases |