Evidence-based Standards in the Design of Family Support Programmes in Spain / [Estándares basados en la evidencia en el diseño de programas de apoyo familiar en España

The positive parenting approach has highlighted the importance of supporting families to perform the functions associated with their parental role and to improve children’s well-being. The aims of this study were to identify and describe the characteristics of family support programmes in Spain, and to examine the extent to which they meet evidence-based standards for programme formulation. The sample includes 57 programmes identified by the Spanish Family Support Network, which belongs to the pan-European Family Support Network(EurofamNet) . Frequency analyses and contingency tables were carried out. The results show that the Spanish programmes meet several evidence-based standards for programme formulation (i.e., manualization). However, further efforts are required in some areas, such as universality and interdisciplinarity of family support programmes. The findings provide a platform from which to design new initiatives in accordance with standards for prevention programmes, and inform stakeholders and politicians in drawing up evidence-based public policies.(AU)

El enfoque de parentalidad positiva ha puesto de manifiesto la importancia de apoyar a las familias en el ejercicio de las funciones asociadas a su rol parental y para que aumenten el bienestar de los niños. Los objetivos de este estudio fueron identificar y describir las características de los programas de apoyo a la familia en España y examinar en qué medida cumplen con los estándares basados en la evidencia para la formulación de programas. La muestra incluye 57 programas identificados por la Red Española de Apoyo a la Familia, que pertenece a la Red Paneuropea de Apoyo a la Familia (EurofamNet). Se realizaron análisis de frecuencia y tablas de contingencia. Los resultados muestran que los programas españoles cumplen varios estándares basados en la evidencia para la formulación de programas (por ejemplo, que están manualizados). Sin embargo, es necesario realizar más esfuerzos en algunas áreas, como la universalidad y la interdisciplinariedad de los programas de apoyo familiar. Los resultados proporcionan una plataforma desde la que diseñar nuevas iniciativas de acuerdo con los estándares de los programas de prevención, y orientan a las partes interesadas y a los políticos en la elaboración de políticas públicas basadas en la evidencia.(AU)

Glycemic control and maternal and fetal outcomes in pregnant women with type 1 diabetes according to the type of basal insulin.

OBJECTIVE: To examine the potential role of the type of basal insulin on glycemic control and maternal and foetal outcomes in pregnant women with type 1 diabetes (T1DM). STUDY DESIGN: Retrospective cohort study of pregnancies attended at 18 Spanish tertiary hospitals. INCLUSION CRITERIA: T1DM, singleton pregnancies, delivery between 2002-2010, and use of the same basal and prandial insulin from before pregnancy until delivery. RESULTS: A total of 1534 pregnancies were included. The basal insulin most commonly used was Neutral Protamine Hagedorn (NPH) (51.7%), followed by glargine (23.2%) and continuous subcutaneous insulin infusion (CSII) (21.1%). CSII users had longer diabetes duration. Multiple logistic regression analysis showed that CSII was independently associated with lower doses of insulin, higher glycated haemoglobin (HbA1c) in all trimesters, and higher rates of miscarriage, preterm birth and neonatal hypoglycemia. Glargine was related to a higher risk of preterm birth and a small-for-gestational age infant (SGA). The odds ratios (OR) of the associations between insulin type and clinical outcomes (from 0.642 to 4.894) have a relevant magnitude. CONCLUSIONS: In this observational study of pregnant women with T1DM, the type of basal insulin was independently associated with metabolic variables and foetal outcomes.

Analysing urban resilience through alternative stormwater management options: application of the conceptual Spatial Decision Support System model at the neighbourhood scale.

Recent changes in cities and their environments, caused by rapid urbanisation and climate change, have increased both flood probability and the severity of flooding. Consequently, there is a need for all cities to adapt to climate and socio-economic changes by developing new strategies for flood risk management. Following a risk paradigm shift from traditional to more integrated approaches, and considering the uncertainties of future urban development, one of the main emerging tasks for city managers becomes the development of resilient cities. However, the meaning of the resilience concept and its operability is still not clear. The goal of this research is to study how urban engineering and design disciplines can improve resilience to floods in urban neighbourhoods. This paper presents the conceptual Spatial Decision Support System (DS3) model which we consider a relevant tool to analyse and then implement resilience into neighbourhood design. Using this model, we analyse and discuss alternative stormwater management options at the neighbourhood scale in two specific areas: Rotterdam and New Orleans. The results obtained demonstrate that the DS3 model confirmed in its framework analysis that stormwater management systems can positively contribute to the improved flood resilience of a neighbourhood.

The biological family from the perspective of kinship fostered adolescents / La familia biológica desde la perspectiva del adolescente acogido en familia extensa

Background: Previous studies emphasise the importance of the biological family to the welfare of fostered adolescents. However, the majority of these studies only take into consideration the viewpoints of the professionals, foster parents and biological parents, not those of the adolescents themselves. For this reason little is known about the perceptions the adolescents have and the needs they express. Method: This study has gathered data from 57 adolescents in kinship family foster care in Spain (AFE). The study applied qualitative reseach, using focus groups to gather data, and the Atlas.ti programme to analyse the data. The qualitative data give us a more profound understanding of how the fostered adolescents relate to their biological families. Results: The results highlight the specific needs of these adolescents with regard to: a) understanding of their family history, b) the impact of visits from and relationship with their biological family, and c) the relationship between the biological family and the foster family. Conclusions: These findings reveal implications to consider when creating support programmes aimed at this group (AU)

Antecedentes: los estudios anteriores demuestran la importancia que tiene la familia biológica en el bienestar de los adolescentes acogidos. Ahora bien, la mayoría de estos estudios se han realizado tomando como informantes a profesionales, acogedores o padres biológicos y han dejado de lado la perspectiva de los adolescentes. Así pues, conocemos poco sobre cómo es percibido este tema por los propios adolescentes y cuáles son las necesidades que expresan al respecto. Método: la investigación recoge información de 57 adolescentes en situación de acogimiento familiar en familia extensa en España (AFE). La metodología del estudio es cualitativa, se utiliza la técnica del focus grup para recoger información y el programa Atlas.ti para el análisis de datos. Los datos cualitativos nos permiten profundizar en la visión de los adolescentes acogidos en torno al tema de la familia biológica. Resultados: los resultados nos indican necesidades particulares en torno a: a) la comunicación de la historia familiar, b) las visitas y la relación con su familia biológica, y c) la relación entre familia biológica y acogedora. Conclusiones: estos hallazgos sugieren implicaciones para la práctica que pasan por articular programas de apoyo específicos dirigidos a este colectivo (AU)

Treatment of hyperprolactinemia: a systematic review and meta-analysis.

BACKGROUND: Hyperprolactinemia is a common endocrine disorder that can be associated with significant morbidity. We conducted a systematic review and meta-analyses of outcomes of hyperprolactinemic patients, including microadenomas and macroadenomas, to provide evidence-based recommendations for practitioners. Through this review, we aimed to compare efficacy and adverse effects of medications, surgery and radiotherapy in the treatment of hyperprolactinemia. METHODS: We searched electronic databases, reviewed bibliographies of included articles, and contacted experts in the field. Eligible studies provided longitudinal follow-up of patients with hyperprolactinemia and evaluated outcomes of interest. We collected descriptive, quality and outcome data (tumor growth, visual field defects, infertility, sexual dysfunction, amenorrhea/oligomenorrhea and prolactin levels). RESULTS: After review, 8 randomized and 178 nonrandomized studies (over 3,000 patients) met inclusion criteria. Compared to no treatment, dopamine agonists significantly reduced prolactin level (weighted mean difference, -45; 95% confidence interval, -77 to -11) and the likelihood of persistent hyperprolactinemia (relative risk, 0.90; 95% confidence interval, 0.81 to 0.99). Cabergoline was more effective than bromocriptine in reducing persistent hyperprolactinemia, amenorrhea/oligomenorrhea, and galactorrhea. A large body of noncomparative literature showed dopamine agonists improved other patient-important outcomes. Low-to-moderate quality evidence supports improved outcomes with surgery and radiotherapy compared to no treatment in patients who were resistant to or intolerant of dopamine agonists. CONCLUSION: Our results provide evidence to support the use of dopamine agonists in reducing prolactin levels and persistent hyperprolactinemia, with cabergoline proving more efficacious than bromocriptine. Radiotherapy and surgery are useful in patients with resistance or intolerance to dopamine agonists.

Natural history of nonfunctioning pituitary adenomas and incidentalomas: a systematic review and metaanalysis.

CONTEXT: The natural history of pituitary incidentalomas (PIs) and nonfunctioning pituitary adenomas (NFPAs) remains poorly understood. OBJECTIVE: The objective of the study was to synthesize the literature on the prognostic factors involved in the progression of PIs and NFPAs in patients followed up conservatively. DATA SOURCES: We searched MEDLINE, EMBASE, and Cochrane CENTRAL. We sought to identify further studies by reviewing the reference lists from selected studies and reviews and by querying experts. STUDY SELECTION: Eligible studies were longitudinal observational cohort studies that enrolled patients with PIs/NFPAs and followed them up without any treatment from the time of detection and reported on mortality, lesion progression, and development of pituitary hormonal deficiency, apoplexy, or visual field defects. DATA EXTRACTION: Reviewers working independently and in duplicate determined studies' eligibility and collected descriptive, methodological quality, and outcome data. Event rates per 100 person-years (PYs) and associated 95% confidence intervals (CIs) were estimated from each study and pooled using the random-effects model. DATA SYNTHESIS: The 11 included studies had noncomparative single-cohort design. Follow-up duration ranged from 3 to 15 yr. There was a greater tendency for tumor growth in macroadenomas (12.5 per 100 PYs; 95% CI 7.9, 17.2) and in solid lesions (5.7 per 100 PYs; 95% CI 2.3, 9.2) in comparison with microadenomas (3.3 per 100 PYs; 95% CI 2.1, 4.5) and cystic lesions (0.05 per 100 PYs; 95% CI 0.0, 0.2). The development of pituitary apoplexy and worsening of visual field defects were rare. The overall incidence of new endocrine dysfunction was 2.4 per 100 PYs; 95% CI 0.0, 6.4. The majority of these analyses were associated with significant heterogeneity. There was a trend that did not reach statistical significance for greater incidence of pituitary apoplexy and new endocrine dysfunction worsening in macroadenomas compared with microadenomas. The quality of the evidence (risk of bias) was very low due to heterogeneity, methodological limitations, and imprecision caused by the small number of events. CONCLUSIONS: Despite the relatively high prevalence of PIs/NFPAs, the evidence on the natural history of these entities is scarce and of low quality. PIs/NFPAs seem to have fairly rare complications that may be more common when lesions are large (>10 mm) and solid.

Outcomes of surgical treatment for nonfunctioning pituitary adenomas: a systematic review and meta-analysis.

BACKGROUND: Surgery is commonly used in the management of pituitary nonfunctioning adenomas (NFPA). The goal of this systematic review and meta-analysis is to evaluate the effect of surgery on mortality, surgical complications, pituitary function and vision. METHODS: We searched MEDLINE, EMBASE and Cochrane CENTRAL, queried experts and reviewed the reference list of included publications. Eligible studies were comparative and noncomparative longitudinal studies that enroled patients with NFPA who underwent surgery (alone or in combination with other therapies). Reviewers, working independently and in duplicate, determined study eligibility with adequate reproducibility and extracted descriptive, quality and outcome data. Risks, relative risks (RR) and 95% confidence intervals (CIs) were estimated from each study and pooled using random-effects meta-analysis. RESULTS: Most included studies were uncontrolled case series in which patients received a combination of surgery and radiotherapy. The overall quality of the evidence was very low. Median follow-up was 4·29 years. When surgery was not combined with radiotherapy, there was an increased risk of tumour recurrence (RR 1·97; 95% CI, 1·15-3·35). Complications were more likely with the transcranial than with the transsphenoidal approach (mortality RR 4·89; 95% CI, 3·15-6·47; new anterior pituitary deficits RR 4·90; 95% CI, 2·94-7·82; and persistent diabetes insipidus RR 2·50; 95% CI, 1·05-5·35). Overall, transsphenoidal surgery had fairly low perioperative mortality (≤ 1%) and low complication rate (≤ 5% for all patient-important outcomes), but only less than a third of the patients had improvement in pituitary function. CONCLUSIONS: Observational evidence supports the association between a combined approach of transsphenoidal surgery with radiotherapy and improvements in visual field defects and reduction in tumour recurrence.

Clinical review 1: Adverse effects of testosterone therapy in adult men: a systematic review and meta-analysis.

CONTEXT: The risks of testosterone therapy in men remain poorly understood. OBJECTIVE: The aim of this study was to conduct a systematic review and meta-analyses of testosterone trials to evaluate the adverse effects of testosterone treatment in men. DATA SOURCES: We searched MEDLINE, EMBASE, and Cochrane CENTRAL from 2003 through August 2008. Review of reference lists and contact with experts further identified candidate studies. STUDY SELECTION: Eligible studies were comparative, randomized, and nonrandomized and reported the effects of testosterone on outcomes of interest (death, cardiovascular events and risk factors, prostate outcomes, and erythrocytosis). Reviewers, working independently and in duplicate, determined study eligibility. DATA EXTRACTION: Reviewers working independently and in duplicate determined the methodological quality of studies and collected descriptive, quality, and outcome data. DATA SYNTHESIS: The methodological quality of the 51 included studies varied from low to medium, and follow-up duration ranged from 3 months to 3 yr. Testosterone treatment was associated with a significant increase in hemoglobin [weighted mean difference (WMD), 0.80 g/dl; 95% confidence interval (CI), 0.45 to 1.14] and hematocrit (WMD, 3.18%; 95% CI, 1.35 to 5.01), and a decrease in high-density lipoprotein cholesterol (WMD, -0.49 mg/dl; 95% CI, -0.85 to -0.13). There was no significant effect on mortality, prostate, or cardiovascular outcomes. CONCLUSIONS: The adverse effects of testosterone therapy include an increase in hemoglobin and hematocrit and a small decrease in high-density lipoprotein cholesterol. These findings are of unknown clinical significance. Current evidence about the safety of testosterone treatment in men in terms of patient-important outcomes is of low quality and is hampered by the brief study follow-up.

Prenatal dexamethasone use for the prevention of virilization in pregnancies at risk for classical congenital adrenal hyperplasia because of 21-hydroxylase (CYP21A2) deficiency: a systematic review and meta-analyses.

CONTEXT: Prenatal treatment with dexamethasone to prevent virilization in pregnancies at risk for classical congenital adrenal hyperplasia (CAH) remains controversial. OBJECTIVE: To conduct a systematic review and meta-analyses of studies that evaluated the effects of dexamethasone administration during pregnancies at risk for classical CAH because of 21-hydroxylase deficiency (CYP21A2). DATA SOURCES: We searched MEDLINE, EMBASE, and Cochrane CENTRAL from inception through August 2009. Review of reference lists and contact with CAH experts further identified candidate studies. STUDY SELECTION: Reviewers working independently and in duplicate determined trial eligibility. Eligible studies reported the effects on either foetal or maternal outcomes of dexamethasone administered during pregnancy compared to a control group that did not receive any treatment. DATA EXTRACTION: Reviewers working independently and in duplicate determined the methodological quality of studies and collected data on patient characteristics, interventions, and outcomes. DATA SYNTHESIS: We identified only four eligible observational studies (325 pregnancies treated with dexamethasone). The methodological quality of the included studies was overall low. Meta-analysis demonstrates a reduction in foetus virilization measured by Prader score in female foetuses treated with dexamethasone initiated early during pregnancy (weighted mean difference, -2.33, 95% CI, -3.38, -1.27). No deleterious effects of dexamethasone on stillbirths, spontaneous abortions, foetal malformations, neuropsychological or developmental outcomes were found although these data are quite sparse. There was increased oedema and striae in the mothers treated with dexamethasone. There were no data on long-term follow-up of physical and metabolic outcomes in children exposed to dexamethasone. CONCLUSIONS: The observational nature of the available evidence and the overall small sample size of the whole body of the literature significantly weaken inferences about the benefits and harms of dexamethasone in this setting. Dexamethasone seems to be associated with reduction in foetus virilization without significant maternal or foetal adverse effects. However, this review underscores the current uncertainty and further investigation is clearly needed. The decision about initiating treatment should be based on patients' values and preferences and requires fully informed and consenting parents.

Aspirin for the primary prevention of cardiovascular events: a systematic review and meta-analysis comparing patients with and without diabetes.

OBJECTIVE: The negative results of two randomized controlled trials (RCTs) have challenged current guideline recommendations for using aspirin for primary prevention of cardiovascular events among patients with diabetes. We therefore sought to determine if the effect of aspirin for primary prevention of cardiovascular events and mortality differs between patients with and without diabetes. RESEARCH DESIGN AND METHODS: We conducted a systematic search of MEDLINE, EMBASE, Cochrane Library, Web of Science, and Scopus since their inceptions until November 2008 for RCTs of aspirin for primary prevention of cardiovascular events. Blinded pairs of reviewers evaluated studies and extracted data. Random-effects meta-analysis and Bayesian logistic regression were used to estimate the ratios of relative risks (RRs) of outcomes of interest among patients with and without diabetes. A 95% CI that crosses 1.00 indicates that the effect of aspirin does not differ between patients with and without diabetes. RESULTS: Nine RCTs with moderate to high methodological quality contributed data to the analyses. The ratios of RRs comparing the benefit of aspirin among patients with diabetes compared with patients without diabetes for mortality, myocardial infarction, and ischemic stroke were 1.12 (95% CI 0.92-1.35), 1.19 (0.82-1.17), and 0.70 (0.25-1.97), respectively. CONCLUSIONS: Whereas estimates of benefit among patients with diabetes remain imprecise, our analysis suggests that the relative benefit of aspirin is similar in patients with and without diabetes.

Maternal glucose tolerance status influences the risk of macrosomia in male but not in female fetuses.

OBJECTIVE: To elucidate whether the risk of macrosomia, large for gestational age (LGA) and small for gestational age (SGA) is influenced by maternal body mass index and glucose tolerance differently in male and female fetuses. METHODS: A population study was conducted in 16 general hospitals from the Spanish National Health Service that included 9270 consecutive women with singleton pregnancies and without a former diagnosis of diabetes mellitus who delivered 4793 male and 4477 female newborns. Logistic regression analyses were performed to predict the effect of body mass index (BMI) category and glucose tolerance on macrosomia, large for gestational age newborns (LGA) and small for gestational age newborns (SGA) Separate analyses according to foetal sex were carried out for each outcome. The results were adjusted for maternal age, gestational age and pregnancy-induced hypertension. RESULTS: There were significant differences between males and females in the percentage of infants who had macrosomia, LGA or SGA. Maternal BMI category was positively associated with the risk of macrosomia and LGA in both male and female newborns. In addition, there was a negative association between maternal BMI and SGA that only reached significance in males. In contrast, gestational diabetes was only a predictor of macrosomia exclusively in male fetuses (OR 1.67, 95% CI 1.12 to 2.49) CONCLUSIONS: There is sexual dimorphism in the risk of abnormal birth weight attributed to maternal glucose tolerance status. A closer surveillance of foetal growth might be warranted in pregnant women with abnormal glucose tolerance carrying a male fetus.

Body mass index has a greater impact on pregnancy outcomes than gestational hyperglycaemia.

AIMS/HYPOTHESIS: We evaluated diabetes-related pregnancy outcomes in a cohort of Spanish women in relation to their glucose tolerance status, prepregnancy BMI and other predictive variables. METHODS: The present paper is part of a prospective study to evaluate the impact of American Diabetes Association (2000) criteria in the Spanish population. A total of 9,270 pregnant women were studied and categorised as follows according to prepregnancy BMI quartiles and glucose tolerance status: (1) negative screenees; (2) false-positive screenees; (3) gestational diabetes mellitus (GDM) according to American Diabetes Association criteria only; and (4) GDM according to National Diabetes Data Group criteria (NDDG). We evaluated fetal macrosomia, Caesarean section and seven secondary outcomes as diabetes-related pregnancy outcomes. The population-attributable and population-prevented fractions of predictor variables were calculated after binary logistic regression analysis with multiple predictors. RESULTS: Both prepregnancy BMI and abnormal glucose tolerance categories were independent predictors of pregnancy outcomes. The upper quartile of BMI accounted for 23% of macrosomia, 9.4% of Caesarean section, 50% of pregnancy-induced hypertension and 17.6% of large-for-gestational-age newborns. In contrast, NDDG GDM accounted for 3.8% of macrosomia, 9.1% of pregnancy-induced hypertension and 3.4% of preterm births. CONCLUSIONS/INTERPRETATION: In terms of population impact, prepregnancy maternal BMI exhibits a much stronger influence than abnormal blood glucose tolerance on macrosomia, Caesarean section, pregnancy-induced hypertension and large-for-gestational-age newborns.

Potential impact of American Diabetes Association (2000) criteria for diagnosis of gestational diabetes mellitus in Spain.

AIMS/HYPOTHESIS: This study was carried out to determine the impact of American Diabetes Association (ADA) 2000 criteria for the diagnosis of gestational diabetes mellitus (GDM) in the Spanish population. METHODS: Pregnant women were assigned to one of four categories: negative screenees, false-positive screenees, ADA-only-GDM (untreated) and GDM according to National Diabetes Data Group (NDDG) criteria (treated). Fetal macrosomia and Caesarean section were defined as primary outcomes, with seven additional secondary outcomes. RESULTS: Of 9,270 pregnant women screened for GDM, 819 (8.8%) met NDDG criteria. If the threshold for defining GDM had been lowered to ADA criteria, an additional 2.8% of women would have been defined as having the condition (relative increase of 31.8%). Maternal characteristics of women with ADA-only-GDM were between those of false-positive screenees and women with NDDG-GDM. The risk of diabetes-associated complications was slightly elevated in the individuals who would have been classified as abnormal only after the adoption of ADA criteria. In addition, the ADA-only-GDM contribution to morbidity was lower than that of other variables, especially BMI. CONCLUSIONS/INTERPRETATION: Use of the ADA criteria to identify GDM would result in a 31.8% increase in prevalence compared with NDDG criteria. However, as the contribution of these additionally diagnosed cases to adverse GDM outcomes is not substantial, a change in diagnostic criteria is not warranted in our setting.

Gestational diabetes mellitus: metabolic control during labour.

The purpose of this study was to assess, in women with gestational diabetes mellitus (GDM): 1) metabolic control during labour using a standardised protocol; 2) the influence of therapy during pregnancy in intrapartum metabolic control and insulin requirements; and 3) the impact of maternal glycaemia during labour on neonatal hypoglycaemia. An observational study of 85 women with GDM (54 insulin-treated) was performed. Intrapartum metabolic management included i.v. glucose and insulin infusions, urinary ketone measurement and hourly capillary blood glucose (CBG) monitoring. Mean CBG from arrival to delivery was 4.7 +/- 1.1 mmol/l with 83% of mean CBG values within the target range (2.8-6.9 mmol/l). Mean CBG and insulin requirements were unrelated to therapy during pregnancy, but hypoglycaemia (CBG<2.8 mmol/l) was more frequent in women receiving insulin during pregnancy (40.7 vs 19.4 %, p<0.01). In several logistic regression models, CBG during labour was predictive of neonatal hypoglycaemia. We conclude that in women with GDM, the use of a standardised intrapartum management protocol is associated to fair metabolic control, that insulin requirements during labour are unrelated to therapy during pregnancy and that high CBG during labour increases the risk of neonatal hypoglycaemia.

Effects of nicotinamide and intravenous insulin therapy in newly diagnosed type 1 diabetes.

OBJECTIVE: To investigate the effect of intravenous insulin therapy combined with nicotinamide in the metabolic control and beta-cell function of newly diagnosed type 1 diabetic subjects in comparison with intensive insulin therapy and nicotinamide alone. RESEARCH DESIGN AND METHODS: A total of 34 newly diagnosed type 1 diabetic patients were included. After the correction of initial metabolic disturbances, subjects were randomly assigned to the following three groups within 72 h after admission: 1) intensive insulin therapy + placebo (C) (n = 12); 2) intensive insulin therapy + nicotinamide, 700 mg three times a day (NIC) (n = 11); and 3) 72-h intravenous insulin followed by intensive insulin therapy + nicotinamide, 700 mg three times a day (NIV) (n = 11). The subjects were monitored for 12 months. GAD, tyrosine phosphatase antibodies, and insulin autoantibodies were measured. C-peptide was measured basally and after 2, 4, 6, 8, and 10 min of 1 mg intravenous glucagon. HbA1c, glucagon, and antibody measurements were determined initially and at 1, 3, 6, 9, and 12 months. RESULTS: HbA1c values declined to normal after treatment was initiated in all groups and remained not significantly different during the follow-up period. We did not find differences between experimental (NIC and NIV) and placebo (C) groups in terms of beta-cell function, considering basal or glucagon-stimulated C-peptide (maximal stimulated C-peptide and area under the curve [AUC] of C-peptide) values during the follow-up period. After pooling data from the NIC and NIV groups (both including nicotinamide) and comparing it with data from the C group, the results remained unchanged. At diagnosis, GAD positivity was observed in 10 of 12, 8 of 11, and 10 of 11 subjects (NS) in the C, NIC, and NIV groups, respectively, and IA2 positivity was observed in 3 of 12, 4 of 11, and 4 of 11 subjects (NS) in the C, NIC, and NIV groups, respectively. Antibody titers displayed a similar behavior in all groups during the follow-up period. CONCLUSIONS: Our pilot study failed to demonstrate that the addition of 72-h intravenous insulin and nicotinamide to conventional intensive insulin therapy produces any beneficial effect in newly diagnosed type 1 diabetic subjects in terms of beta-cell function and metabolic control.

The role of IGF binding protein-3 as a parameter of activity in acromegalic patients.

OBJECTIVE: The production of insulin-like growth factor binding protein-3 (IGFBP-3), the main IGF-I binding protein, is regulated by GH, and its serum levels are increased in acromegaly. We investigated its potential value as a parameter of acromegaly activity or remission in comparison with IGF-I, taking GH suppression below 2 microg/l after glucose load as the normal standard. METHODS: Data from 40 acromegalic patients (12 males and 28 females, aged 28 to 79 years) were obtained retrospectively from stored samples. From these, 145 pairs of IGF-I/IGFBP-3 values were collected; in 67 of them, simultaneous measurement of GH after glucose loading allowed their classification as active or inactive acromegaly. Relationships between IGF-I, IGFBP-3 and GH after glucose load were assessed, as well as differences between IGF-I and IGFBP-3 levels in active and inactive acromegaly. RESULTS: Significant positive correlation between IGF-I and IGFBP-3 in 145 samples was observed (r=0.49, P<0. 0001). As for the 67 samples in which activity or remission could be defined in terms of GH after glucose load, 50 were active and 17 inactive. Both IGF-I and IGFBP-3 significantly correlated with minimum GH (r=0.53, P<0.0001 and r=0.41, P<0.001 respectively). For both parameters, significant differences of means between active and inactive cases were observed (623+/-296 vs 300+/-108 ng/ml, P<0.0001 for IGF-I, and 4.1+/-1.3 vs 3.2+/-0.9 microg/ml, P<0.006 for IGFBP-3). Yet, when comparing in individual cases their classification as active or inactive with the finding of normal or increased IGF-I and IGFBP-3, among active cases 16% appeared as normal according to IGF-I, and 50% appeared as normal in terms of IGFBP-3. Among inactive cases, 23.5% appeared as active according to IGF-I, while 17.5% appeared as active in terms of IGFBP-3. CONCLUSION: Even though IGFBP-3 reflects GH secretion, it offers no advantage over IGF-I in the assessment of acromegaly, and it may underestimate disease activity in acromegalic patients.

Successful pancreas and kidney transplantation: a view of metabolic control.

BACKGROUND: Pancreas and kidney transplantation (PKTx) has become the treatment of choice in uremic patients with insulin-dependent diabetes mellitus (IDDM). In these patients, the pancreatic graft provides an endogenous source of insulin. However, the determination of its long-term effect on metabolic control is crucial in order to establish the real efficacy of this treatment in diabetic patients. In this article, we describe the experience of the University of Barcelona in short- and long-term metabolic control in PKTx recipients. SUBJECTS AND METHODS: We performed seriated determinations of glycosilated hemoglobin (HbA1c) and oral glucose tolerance tests (OGTT) in 55 patients who underwent PKTx at our center from 1983 to 1996 with both grafts functioning for more than 1 yr (mean follow-up 4.2 +/- 2.3 yr). Basal glucose and insulin levels, areas under the curve (AUC) of glycemia and insulinemia after OGTT were analyzed throughout follow-up, as well as fasting insulin resistance index (FIRI). RESULTS: HbA1c levels throughout follow-up were within the normal range. The OGTT was normal in 80% of the patients 5 yr after transplantation. Hyperinsulinemia was present throughout follow-up. Over time, no differences were detected in the AUC of glycemia and insulinemia between controls and patients with PKTx. During the evolution, no differences were found in FIRI, in spite of increasing body weight. CONCLUSION: When successful, PKTx provides long-term normalization of glycemic control, assessed by HbA1c and OGTT, despite the existence of sustained hyperinsulinemia. Our results strongly suggest that PKTx is the most effective treatment for uremic patients with IDDM from a metabolic point of view.

In pregnancies with gestational diabetes mellitus and intensive therapy, perinatal outcome is worse in small-for-gestational-age newborns.

OBJECTIVE: This study analyzed the relationship between birth weight and perinatal outcome among women with gestational diabetes mellitus. STUDY DESIGN: The relationship between perinatal outcome and birth weight was analyzed for 821 pregnancies of women with gestational diabetes mellitus attended in a tertiary hospital and receiving intensive metabolic therapy (normocaloric diet, self-monitoring of blood glucose level and individually tailored insulin regimen when needed). The Mantel-Haenszel test was used to adjust for preterm delivery. RESULTS: Seven percent of neonates were small for gestational age, 85% were appropriate for gestational age, and 8% were large for gestational age. After adjustment for preterm delivery the rates of adverse fetal outcome, low 1-minute Apgar score, and hypoglycemia were greater among small for gestational age neonates than among appropriate and large for gestational age infants (odds ratios 3.08, 2.51, and 3.17, respectively). CONCLUSION: Among women with gestational diabetes mellitus who are receiving intensive therapy, perinatal outcome is worse for small for gestational age neonates than for appropriate and large for gestational age neonates.