Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes: a pilot randomized trial

Nutrition therapy is the cornerstone of treating diabetes mellitus. The inclusion of fish (particularly oily fish) at least two times per week is recommended by current international dietary guidelines for type 2 diabetes. In contrast to a large number of human studies examining the effects of oily fish on different cardiovascular risk factors, little research on this topic is available in patients with type 2 diabetes. The aims of this pilot study were to investigate the effects of a sardine-enriched diet on metabolic control, adiponectin, inflammatory markers, erythrocyte membrane fatty acid (EMFA) composition, and gut microbiota in drug-naïve patients with type 2 diabetes. METHODS: 35 drug-naïve patients with type 2 diabetes were randomized to follow either a type 2 diabetes standard diet (control group: CG), or a standard diet enriched with 100 g of sardines 5 days a week (sardine group: SG) for 6 months. Anthropometric, dietary information, fasting glycated hemoglobin, glucose, insulin, adiponectin, inflammatory markers, EMFA and specific bacterial strains were determined before and after intervention. RESULTS: There were no significant differences in glycemic control between groups at the end of the study. Both groups decreased plasma insulin (SG: -35.3%, P = 0.01, CG: -22.6%, P = 0.02) and homeostasis model of assessment--insulin resistance (HOMA-IR) (SG: -39.2%, P = 0.007, CG: -21.8%, P = 0.04) at 6-months from baseline. However only SG increased adiponectin in plasma compared to baseline level (+40.7%, P = 0.04). The omega-3 index increased 2.6% in the SG compared to 0.6% in the CG (P = 0.001). Both dietary interventions decreased phylum Firmicutes (SG and CG: P = 0.04) and increased E. coli concentrations (SG: P = 0.01, CG: P = 0.03) at the end of the study from baseline, whereas SG decreased Firmicutes/Bacteroidetes ratio (P = 0.04) and increased Bacteroides-Prevotella (P = 0.004) compared to baseline. CONCLUSIONS: Although enriching diet with 100 g of sardines 5 days a week during 6 months to a type 2 diabetes standard diet seems to have neutral effects on glycemic control in drug-naïve patients with type 2 diabetes, this nutritional intervention could have beneficial effects on cardiovascular risk. Furthermore, both dietary interventions decreased HOMA-IR and altered gut microbiota composition of drug-naïve patients with type 2 diabetes

Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes: a pilot randomized trial

Nutrition therapy is the cornerstone of treating diabetes mellitus. The inclusion of fish (particularly oily fish) at least two times per week is recommended by current international dietary guidelines for type 2 diabetes. In contrast to a large number of human studies examining the effects of oily fish on different cardiovascular risk factors, little research on this topic is available in patients with type 2 diabetes. The aims of this pilot study were to investigate the effects of a sardine-enriched diet on metabolic control, adiponectin, inflammatory markers, erythrocyte membrane fatty acid (EMFA) composition, and gut microbiota in drug-naïve patients with type 2 diabetes. Methods 35 drug-naïve patients with type 2 diabetes were randomized to follow either a type 2 diabetes standard diet (control group: CG), or a standard diet enriched with 100 g of sardines 5 days a week (sardine group: SG) for 6 months. Anthropometric, dietary information, fasting glycated hemoglobin, glucose, insulin, adiponectin, inflammatory markers, EMFA and specific bacterial strains were determined before and after intervention. Results There were no significant differences in glycemic control between groups at the end of the study. Both groups decreased plasma insulin (SG: −35.3 %, P = 0.01, CG: −22.6 %, P = 0.02) and homeostasis model of assessment - insulin resistance (HOMA-IR) (SG: −39.2 %, P = 0.007, CG: −21.8 %, P = 0.04) at 6-months from baseline. However only SG increased adiponectin in plasma compared to baseline level (+40.7 %, P = 0.04). The omega-3 index increased 2.6 % in the SG compared to 0.6 % in the CG (P = 0.001). Both dietary interventions decreased phylum Firmicutes (SG and CG: P = 0.04) and increased E. coli concentrations (SG: P = 0.01, CG: P = 0.03) at the end of the study from baseline, whereas SG decreased Firmicutes/Bacteroidetes ratio (P = 0.04) and increased Bacteroides-Prevotella (P = 0.004) compared to baseline. Conclusions Although enriching diet with 100 g of sardines 5 days a week during 6 months to a type 2 diabetes standard diet seems to have neutral effects on glycemic control in drug-naïve patients with type 2 diabetes, this nutritional intervention could have beneficial effects on cardiovascular risk. Furthermore, both dietary interventions decreased HOMA-IR and altered gut microbiota composition of drug-naïve patients with type 2 diabete

Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes : a pilot randomized trial

Nutrition therapy is the cornerstone of treating diabetes mellitus. The inclusion of fish (particularly oily fish) at least two times per week is recommended by current international dietary guidelines for type 2 diabetes. In contrast to a large number of human studies examining the effects of oily fish on different cardiovascular risk factors, little research on this topic is available in patients with type 2 diabetes. The aims of this pilot study were to investigate the effects of a sardine-enriched diet on metabolic control, adiponectin, inflammatory markers, erythrocyte membrane fatty acid (EMFA) composition, and gut microbiota in drug-naïve patients with type 2 diabetes. 35 drug-naïve patients with type 2 diabetes were randomized to follow either a type 2 diabetes standard diet (control group: CG), or a standard diet enriched with 100 g of sardines 5 days a week (sardine group: SG) for 6 months. Anthropometric, dietary information, fasting glycated hemoglobin, glucose, insulin, adiponectin, inflammatory markers, EMFA and specific bacterial strains were determined before and after intervention. There were no significant differences in glycemic control between groups at the end of the study. Both groups decreased plasma insulin (SG: −35.3 %, P = 0.01, CG: −22.6 %, P = 0.02) and homeostasis model of assessment - insulin resistance (HOMA-IR) (SG: −39.2 %, P = 0.007, CG: −21.8 %, P = 0.04) at 6-months from baseline. However only SG increased adiponectin in plasma compared to baseline level (+40.7 %, P = 0.04). The omega-3 index increased 2.6 % in the SG compared to 0.6 % in the CG (P = 0.001). Both dietary interventions decreased phylum Firmicutes (SG and CG: P = 0.04) and increased E. coli concentrations (SG: P = 0.01, CG: P = 0.03) at the end of the study from baseline, whereas SG decreased Firmicutes/Bacteroidetes ratio (P = 0.04) and increased Bacteroides-Prevotella (P = 0.004) compared to baseline. Although enriching diet with 100 g of sardines 5 days a week during 6 months to a type 2 diabetes standard diet seems to have neutral effects on glycemic control in drug-naïve patients with type 2 diabetes, this nutritional intervention could have beneficial effects on cardiovascular risk. Furthermore, both dietary interventions decreased HOMA-IR and altered gut microbiota composition of drug-naïve patients with type 2 diabetes

Diabetis mellitus tipus 2: Impacte metabòlic d'una dieta rica en sardina

[cat] INTRODUCCIÓ: La teràpia nutricional és un dels pilars del tractament de la diabetis tipus 2 (DM2). Diverses organitzacions nacionals i internacionals de nutrició i diabetis recomanen el consum de peix (preferentment peix blau) com a mínim 2 cops a la setmana per prevenir la malaltia cardiovascular. Tot i això, existeixen molt pocs estudis que hagin investigat els efectes de la inclusió del peix blau en el control glucèmic i la sensibilitat a la insulina de pacients amb DM2. OBJECTIUS: L’objectiu primari d’aquesta tesi va ser investigar els efectes d’una dieta rica en sardina en els valors d’hemoglobina glicosilada (HbA1c) de pacients amb DM2 sense tractament antidiabètic. Els objectius secundaris van ser investigar els efectes de la intervenció dietètica en la resistència a la insulina, les concentracions d’adiponectina, marcadors d’inflamació, la pressió arterial, la freqüència cardíaca, el perfil lipídic, la microbiota intestinal, la composició d’àcids grassos en membranes d’eritròcits i la qualitat de vida dels pacients. METODOLOGIA: 35 pacients amb DM2 sense tractament antidiabètic van ser randomitzats per seguir una dieta amb recomanacions generals per la DM2 (grup control: GC), o una dieta amb recomanacions generals per la DM2 enriquida amb 100g de sardina en llauna 5 cops a la setmana (grup sardina: GS) durant 6 mesos. Abans i després de la intervenció dietètica es van determinar l’antropometria, hàbits alimentaris i història dietètica, l’HbA1c, la glucosa, la insulina, l’adiponectina, marcadors d’inflamació, la pressió arterial, la freqüència cardíaca, la composició d’àcids grassos en membranes d’eritròcits i la composició de grups bacterians específics de la microbiota intestinal. Abans i després de la intervenció dietètica també es va avaluar la qualitat de vida dels pacients. RESULTATS: L’HbA1c i la glucosa en dejú van disminuir en els dos grups als 6 mesos de la intervenció dietètica (GS: -0,2 ± 0,1% HbA1c, -9,6 ± 5,4 mg/dL glucosa; GC: -0,3 ± 0,1% HbA1c, -5,2 ± 5,5 mg/dL glucosa) sent només significativa la reducció de l’HbA1c en el GC (p=0,01) respecte els valors basals. Els dos grups d’intervenció van disminuir de manera significativa la insulina plasmàtica (GS: -35%, p=0,01; GC:-22,6%, p=0,02) i el model homeostàtic de resistència a la insulina (HOMA-IR) (SG: -39,2%, p=0,007; CG: -21,8%, p=0,04) als 6 mesos respecte els valors basals. Tot i això, només el GS va incrementar l’adiponectina en plasma en comparació amb l’inici de l’estudi (+40,7%, p=0,04). L’índex omega-3 va augmentar significativament d’un 5,3% a un 8% al GS respecte el GC (p=0,001). Les dues intervencions dietètiques van disminuir les concentracions del fílum Firmicutes (GS i GC: p=0,04) i van incrementar les de grup E. coli (GS: p=0,01, CG: p=0,03) respecte els valors basals. Només el GS va diminuir el ratio Firmicutes/Bacteroidetes (p=0,04) i va incrementar el grup Bacteroides- Prevotella (p=0,004). Tot i que la pressió arterial i el perfil lipídic no es van modificar en resposta a la dieta enriquida amb sardina, si va disminuir la freqüència cardíaca (p=0,01). Els pàrametres de qualitat de vida valorats no es van modificar de manera significativa en el GS en comparació amb el GC. CONCLUSIONS: Els resultats d’aquesta tesi suggereixen que la inclusió de 100g de sardina 5 dies a la setmana durant 6 mesos no millora el control glucèmic però podria tenir efectes beneficiosos sobre el risc cardiovascular de pacients amb DM2 aconseguint valors òptims d’índex omega-3. A més, l’increment d’adiponectina observat en el GS podria indicar beneficis en la inflamació metabòlica, i la modificació de bactèries intestinals específiques en resposta a la dieta rica en sardina revela l’estreta relació entre components dietètics i la microbiota intestinal. Igualment, els resultats mostren que tan una dieta amb recomanacions generals per la DM2 com una dieta rica en sardina poden millorar la resistència a la insulina de pacients amb DM2.[eng] BACKGROUND: Nutrition therapy is the cornerstone of treating diabetes mellitus. The inclusion of fish (particularly oily fish) at least two times per week is recommended by current international dietary guidelines for type 2 diabetes. In contrast to a large number of human studies examining the effects of oily fish on different cardiovascular risk factors, little research on this topic is available in patients with type 2 diabetes. OBJECTIVES: The main objective of this thesis was to investigate the effects of a sardine-enriched diet on glycemic control of drug-naïve patients with type 2 diabetes. The secondary objectives were to investigate the effects of the dietary intervention on insuline resistance, adiponectin, inflammatory markers, blood pressure, heart rate, lipid profile, gut microbiota, erythrocyte membrane fatty acid (EMFA) composition and quality of life of drug-naïve patients with type 2 diabetes. METHODS: 35 drug-naïve patients with type 2 diabetes were randomized to follow either a type 2 diabetes standard diet (control group: CG), or a standard diet enriched with 100 g of sardines 5 days a week (sardine group: SG) for 6 months. Anthropometric, dietary information, quality of life evaluation, fasting glycated hemoglobin, glucose, insulin, adiponectin, inflammatory markers, blood pressure, heart rate, EMFA and specific bacterial strains were determined before and after intervention. RESULTS: There were no significant differences in glycated hemoglobin and fasting glucose between groups at the end of the study (SG: -0,2 ± 0,1% HbA1c, -9,6 ± 5,4 mg/dL fasting glucose; CG: -0,3 ± 0,1% HbA1c, -5,2 ± 5,5 mg/dL fasting glucose). Both groups decreased plasma insulin (SG: −35.3 %, P  =  0.01, CG: −22.6 %, P  =  0.02) and homeostasis model of assessment - insulin resistance (HOMA-IR) (SG: −39.2 %, P  =  0.007, CG: −21.8 %, P  =  0.04) at 6-months from baseline. However only SG increased adiponectin in plasma compared to baseline level (+40.7 %, P  =  0.04). The omega-3 index increased 2.6 % in the SG compared to 0.6 % in the CG (P  =  0.001). Both dietary interventions decreased phylum Firmicutes (SG and CG: P  =  0.04) and increased E. coli concentrations (SG: P  =  0.01, CG: P  =  0.03) at the end of the study from baseline, whereas SG decreased Firmicutes/Bacteroidetes ratio (P  =  0.04) and increased Bacteroides-Prevotella (P  =  0.004) compared to baseline. Although blood pressure and lipid profile did not show any significant changes after the sardine dietary intervention, heart rate only decreased significantly in SG from baseline (P=0.01). The quality life parameters did not differ between groups at the end of the study. CONCLUSIONS: The results of this thesis suggests that the inclusion of 100 g of sardines 5 days a week during 6 months does not improve glycemic control but it could have beneficial effects on cardiovascular risk of drug-naïve patients with type 2 diabetes by achieving optimal levels of Omega-3 Index. Furthermore, the increase observed in adiponectin levels in SG might indicate beneficial effects on metabolic inflammation, and the gut specific bacterial strains modification in response to sardine diet revealed the close relationship between dietary components and gut microbiota. Additionally, the results show that a diet based on general dietary recomendations for type 2 diabetes and also a diet enriched with sardines could improve insuline resistance of drug-naïve patients with type 2 diabetes

Codesign and Feasibility Testing of a Tool to Evaluate Overweight and Obesity Apps

Background: Digital health interventions and mobile technologies can help to reduce the rates of obesity and overweight conditions. Although weight management apps are widely used, they usually lack professional content and evaluation, so the quality of these apps cannot be guaranteed. The EVALAPPS project aims to design and validate a tool to assess the safety and effectiveness of health-related apps whose main goal is to manage and prevent obesity and overweight conditions. Objective: The aim of this paper is two-fold: (a) to co-create and codesign the EVALAPPS assessment tool and (b) to pilot its feasibility among overweight and obese individuals that use weight control apps. Methods: A mixed-methods approach was used. A multidisciplinary team (n = 12) participated in a co-creation workshop to provide proposals and inputs about the look and feel of the content, usability aspects, appearance, sections, and main features of the EVALAPPS tool. The tool was tested for its feasibility among 31 overweight and obese individuals, attending the CP Endocrinologia i Nutrició SL Clinic for the first time. Participants were asked to use a specific weight control app [Yazio (YAZIO GmbH, Erfurt, Germany), My FitnessPal (MyFitnessPal, Austin, TX, USA) or MyPlate (MyPlate, Santa Monica, CA, USA)] for two weeks and then evaluate them by using the EVALAPPS (EVALAPPS, David Ganyan, Barcelona, Spain) (June 2020, David Ganyan, Barcelona, Spain) tool. Seven participants were phone interviewed to gain more insight into the use of the EVALAPPS tool. Results: The co-creation workshop allowed conceptualizing the EVALAPPS tool. The feasibility study showed that all criteria from the Usability and Functionality dimensions had valid answers, while Reliability, Security, Privacy, and Health indicators were the dimensions with less valid answers. In all three apps, the dimension with the highest score was Usability/functionality, followed by app purpose. Clinical effectiveness and Development were the dimensions with the lowest scores in all three tested weight control apps. Conclusions: The participation of the multidisciplinary team and end-users in the conceptualization and testing of a tool to assess health apps was feasible and relevant for the usability of the tool

Dapagliflozin added to metformin reduces perirenal fat layer in type 2 diabetic patients with obesity

Abstract Sodium-glucose co-transporters type 2 inhibitors (SLGT2i) are highly effective in controlling type 2 diabetes, but reported beneficial cardiovascular effects suggest broader actions on insulin resistance. Weight loss may be initially explained by glycosuria-induced net caloric output and secondary volumetric reduction, but its maintenance could be due to loss of visceral fat mass. Structured ultrasound (US) imaging of abdominal adipose tissue (“eco-obesity”) is a recently described methodology used to measure 5 consecutive layers of abdominal fat, not assessable by DEXA or CT scan: superficial subcutaneous (SS), deep subcutaneous (DS), preperitoneal (PP), omental (Om) and right perirenal (RK). PP, Om and RK are predictors of metabolic syndrome (MS) with defined cut-off points. To assess the effect of SLGT2i on every fat depot we enrolled 29 patients with type 2 Diabetes (HbA1c 6.5–9%) and Obesity (IMC > 30 kg/m2) in an open-label, randomized, phase IV trial (EudraCT: 2019-000979-16): the Omendapa trial. Diabetes was diagnosed < 12 months before randomization and all patients were treatment naïve. 14 patients were treated with metformin alone (cohort A) and 15 were treated with metformin + dapaglifozin (cohort B). Anthropometric measures and laboratory tests for glucose, lipid profile, insulin, HOMA, leptin, ultrasensitive-CRP and microalbuminuria (MAL) were done at baseline, 3rd and 6th months. At 6th month, weight loss was −5.5 ± 5.2 kg (5.7% from initial weight) in cohort A and −8.4 ± 4.4 kg (8.6%) in cohort B. Abdominal circumference showed a −2.7 ± 3.1 cm and −5.4 ± 2.5 cm reduction, respectively (p = 0.011). Both Metformin alone (−19.4 ± 20.1 mm; −21.7%) or combined with Dapaglifozin (−20.5 ± 19.4 mm; −21.8%) induced significant Om fat reduction. 13.3% of cohort A patients and 21.4% of cohort’s B reached Om thickness below the cut-off for MS criteria. RK fat loss was significantly greater in cohort B group compared to cohort A, at both kidneys. Only in the Met + Dapa group, we observed correlations between Om fat with leptin/CRP/MAL and RK fat with HOMA-IR. US is a useful clinical tool to assess ectopic fat depots. Both Metformin and Dapaglifozin induce fat loss in layers involved with MS but combined treatment is particularly effective in perirenal fat layer reduction. Perirenal fat should be considered as a potential target for cardiovascular dapaglifozin beneficial effects

Ultrasound measures of abdominal fat layers correlate with metabolic syndrome features in patients with obesity

Summary Objective Abdominal fat ultrasound (US) is a simple clinical tool that may allow measures of fat depots not visible using common dual‐energy X‐ray absorptiometry (DEXA) or computerized tomography (CT) imaging. The aim of this study was to validate the technique, give measures of superficial and profound subcutaneous, preperitoneal, omental and perirenal (retroperitoneal) fat and correlate them with MS markers. Methods Sequential US measures of these five abdominal fat layers were done at 397 adults. Blood pressure (BP), body mass index (BMI), waist, body fat %, HOMA‐IR index (homeostatic model assessment of insulin resistance), lipid profile and leptin were recorded. Metabolic syndrome (MS) was defined according to Cholesterol education programme adult treatment panel III (ATPIII) criteria. Results Subcutaneous and omental fat were increased among people with obesity, whereas preperitoneal and perirenal fat did not show any difference according to BMI or waist. Women showed thicker subcutaneous fat (both superficial and profound), whereas men had bigger omental fat. Both postmenopausal and diabetic patients had changes in omental fat only, whereas patients with fatty liver showed thicker preperitoneal and perirenal fat, as well. MS patients showed both thicker perirenal and omental fat. A cut‐off of 54 mm in male (M)/34 mm in female (F) of omental fat and 22.5 mm (M)/12.5 mm (F) of perirenal fat could be predictive of later MS onset. Conclusions US is a valid method to measure all different abdominal fat depots. Omental and perirenal fat measures may classify patients at risk for MS. Preperitoneal fat depot may also correlate with fatty liver disease

Effect of liraglutide in different abdominal fat layers measured by ultrasound. The importance of perirenal fat reduction

Introduction: Ultrasonography in patients with Obesity allows us to measure different layers of abdominal fat (Superficial subcutaneous, Deep subcutaneous, Preperitoneal, Omental and Perirenal), not assessable by DEXA or CT scan. Omental and Perirenal fat depots are considered predictors of metabolic complications. Liraglutide is particularly effective in reducing weight in patients with insulin-resistance, but its direct impact on each abdominal fat layer is unknown. Methods: We measured, at the L4 level, all 5 abdominal fat depots in 860 patients with obesity (72.8% women. Mean age 56.6±1.5 years. BMI 34.4±4.7 kg/m2. Body fat 47±2%. Abdominal circumference 105.8±3 cm), before and after 6 months of Liraglutide treatment. Laboratory tests for glucose, insulin and lipid profile were routinely done. T-student was used to compare intra-individual differences. Results: Weight loss was 7.5±2.8 Kg (7.96% from baseline), with no differences by sex/age/BMI. Greater loss was observed in patients with higher dosages and NAFLD. All US-measured fat layers showed a significant reduction (p&lt;0.05) at 6th months. Preperitoneal fat showed a -26±5.5% reduction and 46% of the patients went below Metabolic syndrome (MS) risk cut-off values. Omental fat was reduced by -17.8±5% (67% of the patients below MS risk) and perirenal fat by -22.4±4.4% (56% of the patients below MS). Both Omental and Perirenal fat reduction correlated with total and LDL cholesterol. Higher Perirenal fat reduction (-28%) was seen among patients with obesity and hypertension. Perirenal fat also correlated with blood pressure reduction. Conclusion: Liraglutide induces greater fat loss in the layers involved with Metabolic syndrome. However, the maximal reduction is seen at perirenal fat, which has been recently related with Hypertension and could play an important role in modulating kidney’s expansion and intraglomerular pressure. US is a reproducible clinical tool to assess pathologic fat depots in patients living with Obesity