RESUMO
Primary aldosteronism (PA) is the most frequent cause of secondary hypertension (HT), and is associated with a higher cardiometabolic risk than essential HT. However, PA remains underdiagnosed, probably due to several difficulties clinicians usually find in performing its diagnosis and subtype classification. The aim of this consensus is to provide practical recommendations focused on the prevalence and the diagnosis of PA and the clinical implications of aldosterone excess, from a multidisciplinary perspective, in a nominal group consensus approach by experts from the Spanish Society of Endocrinology and Nutrition (SEEN), Spanish Society of Cardiology (SEC), Spanish Society of Nephrology (SEN), Spanish Society of Internal Medicine (SEMI), Spanish Radiology Society (SERAM), Spanish Society of Vascular and Interventional Radiology (SERVEI), Spanish Society of Laboratory Medicine (SEQC(ML)), Spanish Society of Anatomic-Pathology, Spanish Association of Surgeons (AEC).
Assuntos
Hiperaldosteronismo , Humanos , Consenso , Hiperaldosteronismo/diagnóstico , Hiperaldosteronismo/terapia , Hipertensão/diagnóstico , Hipertensão/terapia , Hipertensão/etiologia , Programas de Rastreamento/normas , Programas de Rastreamento/métodos , Sociedades Médicas , Espanha/epidemiologiaRESUMO
BACKGROUND: Laparoscopic adrenalectomy (LA) is the gold standard treatment for unilateral primary aldosteronism. However, satisfactory results have also been published with radiofrequency ablation (RFA). The aim of this study was to compare LA and RFA for the treatment of primary aldosteronism. METHODS: A retrospective cohort study of the patients who underwent LA or RFA in a single center was performed. Morbidity and long-term effectiveness (cure rate and blood pressure control) were analyzed. A multivariate analysis with a propensity score was also performed. RESULTS: Thirty-four patients were included in the study, 24 in the LA group and 10 in the RFA group. Hypertension had been diagnosed a median of 12 years before the intervention. Hypertension was properly controlled before the intervention in 55.9% of the patients. Hypertensive crisis was more common during RFA (4.2% vs. 70.0%, p < 0.001), although no patient suffered any complication because of these crises. LA was longer (174.6 vs. 105.5 min, p = 0.001) and had a longer length of stay (median 2 vs 1 days, p < 0.001). No severe complications were observed in any of the patients. After a median follow-up of 46.2 months, more patients had hypertension cured and blood pressure controlled in the LA group (29.2% vs. 0%, p = 0.078 and 95.5% vs. 50.0%, p = 0.006, respectively). Also, patients in the LA group were taking less antihypertensive drugs (1.8 vs. 3.0, p = 0.054) or mineralocorticoid receptor antagonists (41.7% vs. 90.0%, p = 0.020). Multivariate analysis adjusted by propensity score showed that LA had an OR = 11.3 (p = 0.138) for hypertension cure and an OR = 55.1 (p = 0.040) for blood pressure control. CONCLUSIONS: Although RFA was a less invasive procedure than LA, hypertension was cured and blood pressure was properly controlled in more patients from the LA group. Patients who underwent LA were taking less antihypertensive drugs than patients who had undergone RFA.
Assuntos
Hiperaldosteronismo , Laparoscopia , Ablação por Radiofrequência , Adrenalectomia/métodos , Estudos de Coortes , Humanos , Hiperaldosteronismo/cirurgia , Laparoscopia/métodos , Pontuação de Propensão , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: There is sparse evidence for the impact of gene-diet interaction on gestational diabetes mellitus (GDM) onset. Recent findings have shown that late first-trimester high adherence to a Mediterranean diet (MedDiet) pattern is associated with a GDM risk reduction. The aim of this study was to investigate if this effect could be modulated by TCF7L2 rs7903146 polymorphism.Research design and methods: A total of 874 pregnant women participants in the St Carlos GDM prevention study, were stratified into three groups defined as "High,5-6 on targets", "Moderate, 2-4 on targets" or "Low, 0-1 on targets" adherence to Mediterranean diet according to late first-trimester compliance with six food targets: >12 servings/week of vegetables, >12 pieces/week of fruits, <2 servings/week of juice, >3 servings/week of nuts, >6 days/week and >40 mL/day consumption of extra virgin olive oil. All patients were genotyped for rs7903146 using Taqman technology. RESULTS: Logistic regression analysis revealed that the risk of developing GDM in those with high adherence versus low adherence was significantly reduced only in carriers of the T-allele (CT + TT), with an adjusted odds ratio of 0.15 (95% CI:0.05-0.48). This effect was not observed in CC carriers. Interaction analysis yielded significant rs7903146-MedDiet interaction in GDM risk (p < 0.03). CONCLUSIONS: Women carrying the rs7903146 T-allele who highly adhere to a MedDiet early in pregnancy have lower risk of developing GDM than CC carriers. This reinforces the importance of identifying patients at risk of GDM who would be especially sensitive to nutritional interventions based on their genetic characteristics.
RESUMO
Gestational diabetes mellitus (GDM) is the most frequent morbidity found in pregnancy, and it increases the risk for several maternal-fetal complications. Hispanic women are considered at high risk. The St. Carlos GDM prevention study is a randomized controlled trial (RCT) conducted from 2016-2017. Normoglycemic women were randomized at 12-14 Gestation week (WG) to an intervention group (IG) receiving recommendations based on the MedDiet (supplemented with ExtraVirgin Olive Oil/pistachios), or to a control group (CG), recommended to limit fat intake. After RCT conclusion, IG recommendations were applied to a real-world group (RW) in routine clinical practice. The primary endpoint of the current study is an assessment of the GDM rate in Hispanic participants of the aforementioned studies: 132 RCT, 128 CT, 284 RW participants. The GDM rate was lower in IG: 19/128(14.8%), p = 0.021, and RW: 38/284(13.4%), p = 0.029) than in CG: 34/132(25.8%). Adjusted RR (95%CI) for GDM: 0.72 (0.50-0.97), p = 0.037 in IG and 0.77 (0.61-0.97), p = 0.008 in RW. Rates of urinary tract infections, emergency caesarean-sections and perineal trauma were also lower in IG and RW. Other adverse outcomes were lower in IG vs. CG. In conclusion, a MedDiet-based intervention reduces the rate of GDM and several adverse maternal-fetal outcomes in Hispanic women residing in Spain.
Assuntos
Diabetes Gestacional/prevenção & controle , Dieta Saudável , Dieta Mediterrânea , Estilo de Vida , Resultado da Gravidez , Adulto , Cesárea/estatística & dados numéricos , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/epidemiologia , Feminino , Hemoglobinas Glicadas/metabolismo , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Modelos Logísticos , Gravidez , Estudos Prospectivos , Recomendações Nutricionais , Medição de Risco , Fatores de Risco , Espanha/epidemiologia , Infecções Urinárias/prevenção & controleRESUMO
INTRODUCTION: Background: coronavirus disease 2019 (COVID-19) can induce an exaggerated inflammatory response. Vitamin D is a key modulator of the immune system. We hypothesized that vitamin D deficiency (VDD) could increase the risk of developing severe COVID-19 infection. Methods: patients with confirmed COVID-19 seen at the emergency department of our hospital with recent measurements of 25(OH)D were recruited. We explored the association of vitamin D deficiency (VDD), defined as 25-hydroxyvitamin D < 20 ng/mL, with a composite of adverse clinical outcomes. Results: we included 80 patients, of which 31 (39 %) presented the endpoint. VDD tended to predict an increased risk of developing severe COVID-19 after adjusting for age, gender, obesity, cardiac disease, and kidney disease [OR 3.2 (95 % CI: 0.9-11.4), p = 0.07]. Age had a negative interaction with the effect of VDD on the composite outcome (p = 0.03), indicating that the effect was more noticeable at younger ages. Furthermore, male gender was associated with VDD and with severe COVID-19 at younger ages. Conclusions: in this retrospective study, vitamin D deficiency showed a signal of association with severe COVID-19 infection. A significant interaction with age was noted, suggesting VDD may have a greater impact in younger patients. These findings should be confirmed in larger, prospective, adequately powered studies.
INTRODUCCIÓN: Antecedentes: la enfermedad por coronavirus 2019 (COVID-19) puede inducir una respuesta inflamatoria exagerada. La vitamina D es un modulador clave del sistema inmune. Planteamos que la deficiencia de vitamina D (VDD) podría aumentar el riesgo de desarrollar infección grave por COVID-19. Métodos: se reclutaron pacientes consecutivos que acudieron al servicio de urgencias de nuestro centro con diagnóstico de COVID-19 confirmado (PCR-COVID-19 positiva) y mediciones recientes de 25(OH)D. Exploramos la asociación de la deficiencia de vitamina D (VDD), definida como una 25-hidroxivitamina D < 20 ng/ml, con un compuesto de resultados clínicos adversos. Resultados: se incluyeron 80 pacientes, de los cuales 31 (39 %) presentaron el criterio de valoración primario. El VDD tendió a predecir un mayor riesgo de desarrollar COVID-19 grave después de ajustar edad, sexo, obesidad, enfermedad cardíaca y enfermedad renal [OR: 3,2 (IC 95 %: 0,9-11,4), p = 0,07]. La edad tuvo una interacción negativa con el efecto de la VDD en el resultado compuesto (p = 0,03), lo que indica que el efecto fue más notable a edades más tempranas. Además, el género masculino se asoció con la VDD y con la COVID-19 grave en las edades más jóvenes. Conclusiones: en este estudio retrospectivo, la deficiencia de vitamina D mostró una tendencia de asociación con la infección grave por COVID-19. Se observó una interacción significativa con la edad, lo que sugiere que la VDD puede tener un mayor impacto en los pacientes más jóvenes. Estos hallazgos deben confirmarse en estudios más grandes, prospectivos y con potencia adecuada.
Assuntos
Fatores Etários , Betacoronavirus , Infecções por Coronavirus/etiologia , Pneumonia Viral/etiologia , Deficiência de Vitamina D/complicações , Vitamina D/análogos & derivados , Adulto , Idoso , COVID-19 , Infecções por Coronavirus/sangue , Infecções por Coronavirus/epidemiologia , Feminino , Cardiopatias/complicações , Humanos , Nefropatias/complicações , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Pandemias , Pneumonia Viral/sangue , Pneumonia Viral/epidemiologia , Estudos Retrospectivos , SARS-CoV-2 , Fatores Sexuais , Espanha/epidemiologia , Vitamina D/sangueRESUMO
The intrauterine environment may be related to the future development of chronic diseases in the offspring. The St. Carlos gestational diabetes mellitus (GDM) prevention study, is a randomized controlled trial that evaluated the influence of the early (before 12th gestational week) Mediterranean diet (MedDiet) on the onset of GDM and adverse gestational outcomes. Out of 874 women assessed after delivery (440 control group (CG)/434 intervention group (IG)), 703 children were followed (365/338; CG/IG), with the aim to assess whether the adherence to a MedDiet during pregnancy induces health benefits for the offspring during the first two years of life. Logistic regression analysis showed that the IG in children of mothers with pre-gestational body mass index (BMI) < 25 kg/m2 and normal glucose tolerance (NGT), was associated with a lower risk (RR(95% CI)) of suffering from severe events requiring hospitalization due to bronchiolitis/asthma (0.75(0.58-0.98) and 0.77(0.59-0.99), respectively) or other diseases that required either antibiotic (0.80(0.65-0.98) and 0.80(0.65-0.99), respectively), corticosteroid treatment (0.73(0.59-0.90) and 0.79(0.62-1.00) respectively) or both (all p < 0.05). A nutritional intervention based on the MedDiet during pregnancy is associated with a reduction in offspring's hospital admissions, especially in women with pre-gestational BMI < 25 kg/m2 and NGT.
RESUMO
AIMS: The aim of the study was to evaluate the effect of a Mediterranean diet (MedDiet), enhanced with extra virgin olive oil (EVOO) and nuts, on a composite of adverse maternofoetal outcomes of women with normoglycemia during pregnancy. METHODS: This was a sub-analysis of the St Carlos gestational diabetes mellitus Prevention Study. Only normoglycemic women were analysed (697). They were randomized (at 8-12th gestational weeks) to: standard-care control group (337), where fat consumption was limited to 30% of total caloric intake; or intervention group (360), where a MedDiet, enhanced with EVOO and pistachios (40-42% fats of total caloric intake) was recommended. The primary outcome was a composite of maternofoetal outcomes (CMFOs): at least having 1 event of emergency C-section, perineal trauma, pregnancy-induced hypertension and preeclampsia, prematurity, large-for-gestational-age and small-for gestational-age. RESULTS: Crude relative risk showed that the intervention was associated with a significant reduction in the risk of CMFOs (0.48 [0.37-0.63]; p = 0.0001), with a number-needed-to-treat = 5. Risk of urinary tract infections, emergency C-sections, perineal trauma, large-for-gestational-age and small-for gestational age new-borns were also significantly reduced. CONCLUSION: A MedDiet, enhanced with EVOO and nuts, was associated with a risk reduction of CMFOs in over 50% in normoglycemic pregnant women. Therefore, it might be a potentially adequate diet for pregnant women. TRIAL REGISTRATION: Identifier ISRCTN84389045. The study was registered on September 27, 2013. Last edited on September 26, 2018.
Assuntos
Dieta Mediterrânea , Nozes , Azeite de Oliva/administração & dosagem , Resultado da Gravidez , Adulto , Cesárea/estatística & dados numéricos , Diabetes Gestacional , Feminino , Macrossomia Fetal/epidemiologia , Humanos , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional , Pistacia , Gravidez , Estudos Prospectivos , Infecções Urinárias/epidemiologiaRESUMO
BACKGROUND: Gestational diabetes mellitus (GDM) prevalence is increasing and becoming a major public health concern. Whether a Mediterranean diet can help prevent GDM in unselected pregnant women has yet to be studied. METHODS: We conducted a prospective, randomized controlled trial to evaluate the incidence of GDM with two different dietary models. All consecutive normoglycemic (<92 mg/dL) pregnant women at 8-12 gestational weeks (GW) were assigned to Intervention Group (IG, n = 500): MedDiet supplemented with extra virgin olive oil (EVOO) and pistachios; or Control Group (CG, n = 500): standard diet with limited fat intake. Primary outcome was to assess the effect of the intervention on GDM incidence at 24-28 GW. Gestational weight gain (GWG), pregnancy-induced hypertension, caesarean section (CS), preterm delivery, perineal trauma, small and large for gestational age (SGA and LGA) and admissions to neonatal intensive care unit were also assessed. Analysis was by intention-to-treat. RESULTS: A total of 874 women completed the study (440/434, CG/IG). According to nutritional questionnaires and biomarker analysis, women in the IG had a good adherence to the intervention. 177/874 women were diagnosed with GDM, 103/440 (23.4%) in CG and 74/434(17.1%) in IG, p = 0.012. The crude relative risk (RR) for GDM was 0.73 (95% CI: 0.56-0.95; p = 0.020) IG vs CG and persisted after adjusted multivariable analysis, 0.75(95% CI: 0.57-0.98; p = 0.039). IG had also significantly reduced rates of insulin-treated GDM, prematurity, GWG at 24-28 and 36-38 GW, emergency CS, perineal trauma, and SGA and LGA newborns (all p<0.05). CONCLUSIONS: An early nutritional intervention with a supplemented MedDiet reduces the incidence of GDM and improves several maternal and neonatal outcomes.
Assuntos
Diabetes Gestacional/dietoterapia , Dieta Mediterrânea , Azeite de Oliva/administração & dosagem , Pistacia , Adulto , Diabetes Gestacional/epidemiologia , Feminino , Humanos , Incidência , Recém-Nascido , Estilo de Vida , Gravidez , Resultado da Gravidez , Estudos ProspectivosRESUMO
Despite the widespread prevalence of hyponatremia and its deleterious effects on patients, it is often overlooked and consequently undertreated. This set of four cases provides practical advice on how to identify, diagnose, and treat patients with syndrome of inappropriate antidiuretic hormone (SIADH). The first steps that a physician should take when diagnosing a patient with hyponatremia are to assess the severity of neurological symptoms, and check the patient's volemic status in order to determine whether emergency treatment with hypertonic saline is indicated. Laboratory tests are necessary for the diagnosis of SIADH, but, in severe, symptomatic cases of hyponatremia, patients need treatment before the results of laboratory tests can be obtained. In this series, Case 1 demonstrates how awareness of hyponatremia led to early diagnosis and treatment. Case 2 demonstrates how multiple causes of hyponatremia can be diagnosed and managed sequentially. Case 3 illustrates how a patient with severe symptoms should be treated while waiting for laboratory test results to confirm diagnosis. Case 4 examines how the priorities of a patient should inform the management of their chronic SIADH, using palliative care of a patient with small-cell lung cancer as an example. There are several factors that clinicians should consider when making treatment decisions, including signs and symptoms, risks and benefits of different treatments, psychosocial factors, and the patient's wishes. All the available treatment options have a place in the management of patients with SIADH, and a physician should individualize decisions based on a patient's needs and priorities.
Assuntos
Hiponatremia/etiologia , Síndrome de Secreção Inadequada de HAD/diagnóstico , Síndrome de Secreção Inadequada de HAD/terapia , Idoso , Idoso de 80 Anos ou mais , Diagnóstico Diferencial , Gerenciamento Clínico , Feminino , Humanos , Síndrome de Secreção Inadequada de HAD/complicações , MasculinoRESUMO
AIMS: To compare rates of FPG-HbA1C-based postpartum-glucose disorder (PGD) of women with prior gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (CCc) versus International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGc). METHODS: 1620 women with GDM were divided into CCc group (2007-March 2012, n=915), and IADPSGc group (April 2012-2013, n=705). Pregravid (PG) body weight (BW) and body mass index (BMI) and postdelivery (PD) BW, BMI, waist circumference (WC), HOMA-insulin resistance (HOMA-IR), HbA1c, glucose and lipid profile were analysed. PGD definition: HbA1c ≥5.7% and/or FPG ≥5.6mmol/l. RESULTS: Postpartum screening attendance rates (PSAr) were similar in both groups, CCc: 791 (86.5%) and IADPSGc: 570 (81%) as in PGD rates (PGDr), CCc: 233 (29.5%) and IADPSGc: 184 (32.3%). Both cohorts had similar PG-BMI, WC and PD-BMI. Both CCc and IADPSGc women had a significantly higher probability of having PGD when PG-BMI ≥25Kg/m(2) (CCc: OR: 1.55; IC 95% 1.06-2.26; p=0.016), (IADPSGc: OR: 1.42; IC 95% 1.03-2.38; p=0.046) as well as when WC ≥89.5cm, and age ≥34years, and in CCc women when PD-WG >0Kg, all adjusted by ethnicity and parity. CONCLUSIONS: Changing GDM diagnostic methodology did not affect PSAr and PGDr, in spite of screening more women. Thus, using IADPSGc allowed the identification of a larger number of women with PGD.
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Diabetes Gestacional/diagnóstico , Programas de Rastreamento/métodos , Período Pós-Parto , Adulto , Glicemia/análise , Índice de Massa Corporal , Feminino , Humanos , GravidezRESUMO
UNLABELLED: Early-pregnancy lifestyle (EPL) could influence the development of gestational diabetes mellitus(GDM), depending on the diagnostic criteria used. OBJECTIVE: We studied EPL in 1750 pregnant women using Carpenter-Coustan criteria(CCc), and in 1526 with the International Association of Diabetes and Pregnancy Study Groups criteria(IADPSGc). METHODS: GDM risk factors were assessed in women between 24 and 28 weeks of gestational age during two consecutive years. A semiquantitative frequent-food-consumption questionnaire was used to evaluate lifestyle during pregnancy. Multiple logistic regression analysis was conducted to assess GDM risk with different lifestyle patterns. RESULTS: Using IADPSGc, the GDM ORs (95%CI) for intake/week were: nuts >3 times: 0.59 (0.39-0.91; p < 0.015), refined cereals ≤1 serving: 0.72(0.58-0.89; p < 0.003), juices <4 servings: 0.77 (0.62-0.95; p < 0.017), cookies and pastries <4 servings: 0.71(0.57-0.89; p < 0.003) as compared to opposite habits. No significant nutritional patterns were found to be significant using CCc. The OR (95%CI) for GDM with none of the four risk patterns as compared to having three-four risk factors was 0.21(0.07-0.62; p < 0.005), remaining significant after stratification by BMI, age, obstetric events, parity and family history. The multiple logistic regression model including nutritional categories and pregestational BMI, age, obstetric history, parity, personal/family history, had an area under the curve(AUC) of the receiver operating curve(ROC) for the probability to predict GDM of 0.66 (CI 95%: 0.63-0.69; p < 0.001). CONCLUSION: Our study is the first to identify four early-pregnancy nutritional patterns associated with the GDM when using IADPSGc. Adherence to a low-risk nutritional pattern from early pregnancy on could be an effective strategy for GDM prevention.
Assuntos
Diabetes Gestacional/etiologia , Dieta/efeitos adversos , Estilo de Vida , Fenômenos Fisiológicos da Nutrição Materna , Sobrepeso/fisiopatologia , Adulto , Índice de Massa Corporal , Estudos de Coortes , Estudos Transversais , Diabetes Gestacional/epidemiologia , Diabetes Gestacional/etnologia , Diabetes Gestacional/prevenção & controle , Dieta/etnologia , Dieta Saudável/etnologia , Feminino , Hospitais Urbanos , Humanos , Incidência , Estilo de Vida/etnologia , Fenômenos Fisiológicos da Nutrição Materna/etnologia , Sobrepeso/etnologia , Sobrepeso/prevenção & controle , Cooperação do Paciente/etnologia , Gravidez , Estudos Retrospectivos , Fatores de Risco , Autorrelato , Espanha/epidemiologia , Aumento de PesoRESUMO
OBJECTIVE: The use of the new International Association of the Diabetes and Pregnancy Study Groups criteria (IADPSGC) for the diagnosis of gestational diabetes mellitus (GDM) results in an increased prevalence of GDM. Whether their introduction improves pregnancy outcomes has yet to be established. We sought to evaluate the cost-effectiveness of one-step IADPSGC for screening and diagnosis of GDM compared with traditional two-step Carpenter-Coustan (CC) criteria. RESEARCH DESIGN AND METHODS: GDM risk factors and pregnancy and newborn outcomes were prospectively assessed in 1,750 pregnant women from April 2011 to March 2012 using CC and in 1,526 pregnant women from April 2012 to March 2013 using IADPSGC between 24 and 28 weeks of gestation. Both groups received the same treatment and follow-up regimes. RESULTS: The use of IADPSGC resulted in an important increase in GDM rate (35.5% vs. 10.6%) and an improvement in pregnancy outcomes, with a decrease in the rate of gestational hypertension (4.1 to 3.5%: -14.6%, P < 0.021), prematurity (6.4 to 5.7%: -10.9%, P < 0.039), cesarean section (25.4 to 19.7%: -23.9%, P < 0.002), small for gestational age (7.7 to 7.1%: -6.5%, P < 0.042), large for gestational age (4.6 to 3.7%: -20%, P < 0.004), Apgar 1-min score <7 (3.8 to 3.5%: -9%, P < 0.015), and admission to neonatal intensive care unit (8.2 to 6.2%: -24.4%, P < 0.001). Estimated cost savings was of 14,358.06 per 100 women evaluated using IADPSGC versus the group diagnosed using CC. CONCLUSIONS: The application of the new IADPSGC was associated with a 3.5-fold increase in GDM prevalence in our study population, as well as significant improvements in pregnancy outcomes, and was cost-effective. Our results support their adoption.
Assuntos
Diabetes Gestacional/diagnóstico , Hipertensão Induzida pela Gravidez/prevenção & controle , Programas de Rastreamento , Adulto , Diabetes Gestacional/economia , Feminino , Seguimentos , Idade Gestacional , Humanos , Hipertensão Induzida pela Gravidez/economia , Gravidez , Resultado da Gravidez , Estudos Prospectivos , Fatores de RiscoRESUMO
BACKGROUND: To estimate the proportion of diabetic patients (DPts) with peripheral vascular disease treated at a primary health care site after an endocrinologist-based intervention, who meet ATP III and Steno targets of metabolic control, as well as to compare the outcome with the results of the patients treated by endocrinologists. METHODS: A controlled, prospective over 30-months period study was conducted in area 7 of Madrid. One hundred twenty six eligible diabetic patients diagnosed as having peripheral vascular disease between January 2003 and June 2004 were included in the study. After a treatment period of three months by the Diabetes team at St Carlos Hospital, 63 patients were randomly assigned to continue their follow up by diabetes team (Group A) and other 63 to be treated by the family physicians (FP) at primary care level with continuous diabetes team coordination (Group B). 57 DPts from Group A and 59 from Group B, completed the 30 months follow-up period. At baseline both groups were similar in age, weight, time from diagnosis and metabolic control. The main outcomes of this study were the proportion of patients meeting ATP III and Steno goals for HbA1c (%), Cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, blood pressure, albumine-to-creatinine excretion ratio (ACR), body mass index (BMI), waist circumference (WC), anti-aggregation treatment and smoking status. RESULTS: At the end of the follow up, no differences were found between the groups. More than 37% of diabetic patients assigned to be treated by FP achieved a HbA1c < 6.5%, more than 50% a ACR < 30 mg/g, and more than 80% reached low risk values for cholesterol, LDL cholesterol, triglycerides, diastolic blood pressure and were anti-aggregated, and 12% remained smokers. In contrast, less than 45% achieved a systolic blood pressure < 130 mm Hg, less than 12% had a BMI < 25 Kg.m-2 (versus 23% in group A; p < 0.05) and 49%/30% (men/women) had a waist circumference of low risk. CONCLUSION: Improvements in metabolic control among diabetic patients with peripheral vascular disease treated at a primary health care setting is possible, reaching similar results to the patients treated at a specialized level. Despite such an improvement, body weight control remains more than poor in both levels, mainly at primary care level. General practitioner and endocrinologist coordination care may be important to enhance diabetes management in primary care settings. TRIAL REGISTRATION: Clinical Trial number ISRCTN75037597.