Zastosowanie leku XENical w zapobieganiu cukrzycy u osób z otyłością — badanie XENDOS. Badanie randomizowane z zastosowaniem orlistatu jako dodatkowego, oprócz zmian stylu życia, czynnika zapobiegania cukrzycy typu 2 u pacjentów z otyłością

INTRODUCTION. It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity. A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated. We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight, and thus the incidence of type 2 diabetes, in obese patients. MATERIAL AND METHODS. In a 4-year, double-blind, prospective study, we randomized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo, three times daily. Participants had a BMI &#8805; 30 kg/m2 and normal (79%) or impaired (21%) glucose tolerance (IGT). Primary endpoints were time to onset of type 2 diabetes and change in body weight. Analyses were by intention to treat. RESULTS. Of orlistat-treated patients, 52% completed treatment compared with 34% of placebo recipients (P < 0.0001). After 4 years&#8217; treatment, the cumulative incidence of diabetes was 9.0% with placebo and 6.2% with orlistat, corresponding to a risk reduction of 37.3% (P = 0.0032). Exploratory analyses indicated that the preventive effect was explained by the difference in subjects with IGT. Mean weight loss after 4 years was significantly greater with orlistat (5.8 vs. 3.0 kg with placebo; P < 0.001) and similar between orlistat recipients with impaired (5.7 kg) or normal glucose tolerance (NGT) (5.8 kg) at baseline. A second analysis in which the baseline weights of subjects who dropped out of the study was carried forward also demonstrated greater weight loss in the orlistat group (3.6 vs. 1.4 kg; P < 0.001). CONCLUSIONS. Compared with lifestyle changes alone, orlistat plus lifestyle changes resulted in a greater reduction in the incidence of type 2 diabetes over 4 years and produced greater weight loss in a clinically representative obese population. Difference in diabetes incidence was detectable only in the IGT subgroup; weight loss was similar in subjects with IGT and or NGT.WSTĘP. Ryzyko rozwoju cukrzycy typu 2 wiąże się ściśle z obecnością i czasem trwania nadwagi oraz otyłości. Wpływ wprowadzenia zmian stylu życia na zmniejszenie częstości cukrzycy typu 2 potwierdzono we wcześniejszych badaniach. Wysunięto hipotezę, według której zastosowanie dodatkowego czynnika powodującego zmniejszenie masy ciała u chorych, którym udało się ten cel częściowo osiągnąć pod wpływem zmiany stylu życia, pozwala uzyskać jeszcze lepsze efekty, a w konsekwencji prowadzi do dalszej redukcji częstości cukrzycy typu 2 u pacjentów z otyłością. MATERIAŁ I METODY. Do trwającego 4 lata, prospektywnego, randomizowanego badania, przeprowadzonego metodą podwójnie ślepej próby zakwalifikowano 3305 pacjentów, których losowo podzielono na dwie grupy. W pierwszej grupie, obok wprowadzenia zmian stylu życia, pacjentom podawano 3 razy na dobę orlistat w dawce 120 mg, a w drugiej &#8212; placebo. Wskaźnik masy ciała (BMI, body mass index) uczestników badania był większy lub równy 30 kg/m2, stężenie glukozy było prawidłowe (79%) lub rozpoznawano upośledzoną tolerancję glukozy (IGT, impaired glucose tolerance) (21%). Jako główne kryterium oceny badania przyjęto czas do wystąpienia cukrzycy typu 2 oraz zmianę masy ciała. Przeprowadzono analizę według pierwotnej intencji leczenia (intention to treat). WYNIKI. Leczenie ukończyło 52% badanych otrzymujących orlistat i 34% przyjmujących placebo (p < 0,0001). Po 4 latach terapii skumulowane ryzyko wystąpienia cukrzycy w grupie otrzymującej placebo wyniosło 9%, natomiast w grupie przyjmującej orlistat &#8212; 6,2%, co oznacza redukcję ryzyka o 37,3% (p = 0,0032). Na podstawie analizy uzyskanych danych stwierdzono, że efekt prewencyjny wynikał z różnic wśród pacjentów z upośledzoną tolerancją glukozy. Średnia redukcja masy ciała po 4 latach obserwacji była znacząco wyższa w grupie leczonej orlistatem (5,8 vs. 3,0 kg w grupie otrzymującej placebo; p < 0,001) oraz podobna u pacjentów otrzymujących orlistat z wyjściową upośledzoną (5,7 kg) lub prawidłową tolerancją glukozy (NGT, normal glucose tolerance) (5,8 kg). W drugiej analizie, w której uwzględniono zmiany masy ciała u osób wyłączonych z badania, również wykazano większą redukcję masy ciała w grupie leczonej orlistatem (3,6 vs. 1,4 kg; p < 0,001). WNIOSKI. W badaniu przeprowadzonym w reprezentatywnej populacji osób z otyłością wykazano, że w porównaniu z postępowaniem opartym wyłącznie na zmianie stylu życia, dodanie orlistatu spowodowało większy spadek częstości cukrzycy typu 2 oraz większą redukcję masy ciała w okresie 4 lat. Różnica w częstości cukrzycy była widoczna tylko w podgrupie z IGT, zmniejszenie masy ciała było podobne zarówno w podgrupie z IGT, jak i z NGT

Human obesity. Studies of treatment, leptin and the metabolic syndrome

Aims: To evaluate very low calorie diets (VLCD) in obesity treatment and elucidate leptin's role in the response to severe caloric restriction. To analyse relations between metabolic variables, body composition and liver tests and the interplay between mental distress, socio-demographic variables and cardiovascular risk factors in obesity. Methods: 113 obese were randomised to two years of hypocaloric diet, with or without initial VLCD. 121 obese were randomised to three different initial 16 week VLCD periods followed by hypocaloric diet: either strict VLCD, with or without week one as inpatients, or VLCD plus two minor weekly meals. Blood was sampled from obese subjects before, during and after a VLCD-driven weight reduction and analysed for leptin, insulin, cortisol and thyroid hormones. Relations between maintained weight loss after 48 weeks, baseline levels and changes in hormone levels were analysed. Cross-sectional associations between liver tests, body composition, metabolic variables and alcohol intake were examined and structural equation modelling was applied to investigate relations between body mass index (BMI), visceral adipose tissue (VAT), metabolic variables, mental health and socio-economic variables. Results and conclusions: Two treatment years resulted in significant weight losses with (9.2kg), or without (6.3kg) VLCD. In men there was a significant difference between treatment strategies, 15.5 vs. 5.3kg. Strict VLCD resulted in greater weight losses than the more liberal approach but there was no benefit initiating VLCD in hospital. Low baseline leptin levels and large leptin declines were related to large weight reductions after 48 weeks. There were no, or only weak, relations between changes in leptin and insulin, cortisol and thyroid hormones indicating that leptin might be less important for the human response to semi-starvation. Elevated aminotransferases were positively and reduced bilirubin negatively related to VAT and insulin and might be viewed as additional characteristics of the metabolic syndrome. BMI was the main determinant of VAT. BMI and VAT were main determinants of insulin, while depression, education and physical inactivity had less impact. Insulin and VAT were central determinants of other cardiovascular risk factors. This indicates that BMI should not be underestimated when evaluating the pathogenesis of disturbed metabolism in the obese

Attitudes and beliefs in Swedish midwives and obstetricians towards obesity and gestational weight management

Background Gestational weight interventions are important in maternity care to counteract adverse pregnancy events. However, qualitative findings indicate potential obstacles in the implementation of interventions due to the sensitivity of the subject and existing obesity stigma. Pregnant women have reported disrespectful or unhelpful communication, while some midwives seem to avoid the topic, as not to upset women. This descriptive study aimed to provide knowledge about maternity care providers' beliefs about obesity, and their attitudes towards gestational weight management. Method A web survey was emailed to Swedish maternity care clinics. Existing questionnaires, "Beliefs About Obese People" (BAOP), "Perceived weight bias in health care" and "Attitudes toward obese patients" was used, supplemented with questions formulated for this study. An open free-text question allowed participants to provide a deeper and more nuanced picture of the topic. Results 274 respondents (75% midwives and 25% obstetricians) participated. One third of respondents found obesity to be a more sensitive topic than smoking or alcohol habits, and 17% of midwives agreed to the statement: "I sometimes avoid talking about weight so as not to make the pregnant woman worried or ashamed". Having had training in motivational interviewing seemed positively associated with midwives' inclination to talk about body weight, especially with women with obesity (p = .001), whereas years of working experience were not associated. Having received obesity education increased confidence in providing adequate information, but still only 46% felt they had enough knowledge to provide diet and exercise advice to pregnant women with obesity. Qualitative data revealed great empathy for women with obesity, and a wish to have more obesity education and access to other professionals. Conclusion Swedish maternity care staff displayed empathy for women with obesity and found gestational weight interventions important, but almost one fifth of midwives sometimes avoid the subject of body weight for fear of upsetting women. Education about obesity facts, training in person-centered communication, i.e. motivational interviewing, and access to dieticians may facilitate gestational weight management implementation

Prolonged refeeding improves weight maintenance after weight loss with very-low-energy diets

The aim of the present study was to test the hypothesis that a prolonged refeeding duration after successful very-low-energy diet (VLED)-induced weight loss beneficially affects weight development and eating behaviour. Patients (it 269) were recruited to a I-year obesity treatment programme with 12 weeks of an initial VLED. After the VLED, patients with 10 % weight loss were randomly allocated to I week (group 1) or 6 weeks (group 6) refeeding to an ordinary, energy-reduced diet, and thereafter followed and actively treated for an additional 40 weeks. Eating behaviour (revised twenty-one-item Three-Factor Eating Questionnaire) was measured at baseline, during and after refeeding, and at week 52. Weight change over time in the two treatment groups was tested by repeated-measures analysis in completers and by intention to treat (ITT). Of the patients, 169 (109 women) lost >= 10 % during the VLED and were randomised. At randomisation, weight loss was -16.5 (SD 3.7) % in group I and - 16.7 (SD 4-3) % in group 6 (P=0.73). Between weeks 12 and 52, completers in group 6 regained significantly less weight (3.9 (SD 9.1) %) as compared with group 1 (8.2 (SD 8.3) % P=0.006) (ITT, P=0.05). Completers in group 6 also maintained a higher level of dietary restraint after refeeding was completed, but eating behaviour did not differ at week 52. Weight change after the refeeding periods were completed did not differ significantly between the groups (P=0.06). Overall, longer refeeding duration after successful weight loss with a VLED improves weight maintenance in a 1-year perspective

Injuries in children and adolescents with psychiatric disorders

Background Unintentional injuries are a leading cause of morbidity and mortality in children of all ages. Prevention strategies require knowledge of risk factors, and behavior and psychiatric disorders have been suggested to influence the risk of injury during childhood. While externalizing disorders have been found to increase the risk for injuries, results are mixed regarding internalizing disorders, such as affective and anxiety conditions, and Autism Spectrum Disorders (ASD). There is a need for large scale studies relying on robust data sources. The aim of the present study was to examine the association between psychiatric disorders and injuries requiring medical attention, in a large population-based cohort of 350,000 children and adolescents in Sweden. Methods Data were obtained from the regional health care database Vega. Psychiatric diagnoses and injury diagnoses obtained during 2014-2018 for individuals aged 0-17 years in 2016 were extracted. Descriptive statistics were used to examine differences in 5-year injury prevalence between children with and without different psychiatric diagnoses. Logistic regression was used in age-stratified models to test the association between psychiatric diagnoses and injuries requiring medical attention. Results The results show an increased risk for concurrent injuries in general, but the patterns vary by age and psychiatric disorder. Externalizing disorders and anxiety conditions were associated with concurrent injuries, while individuals with ASD had a lower risk for most injuries included. Affective disorders were associated with an increased risk for wounds, concussion, complications and poisoning, while the risk for fractures was decreased. Self-inflicted injury was more common in all psychiatric conditions investigated during adolescence, except for ASD. Children and adolescents with many types of psychiatric disorders were also at increased risk for a concurrent maltreatment diagnosis. Conclusions A general pattern of increased risk for concurrent injuries in children and adolescents with most psychiatric diagnoses was found, but the associations vary by age and type of psychiatric disorder. The results add to the literature on risk factors for injuries in children and adolescents, supporting diagnosis specific patterns. Several psychiatric diagnoses were associated with a marked increase in injury risk, indicating a high burden of disease for affected individuals.Funding Agencies|Research and Development Sodra Alvsborg; Linkoping University</p

Somatic comorbidity in children and adolescents with psychiatric disorders

In the adult population, psychiatric disorders are associated with somatic illness. Explanatory life style factors have been found, but also a failure to recognize somatic illness in this group. Another factor is side effects from long-term use of antipsychotic drugs. Given the psychiatric-somatic comorbidity in the adult population, it is of interest to investigate whether an association exists already during childhood. The aim of the present study was to investigate the frequency of somatic illness in children and adolescents with a psychiatric diagnose. Data were obtained from the regional health care database Vega, Sweden. Psychiatric and somatic diagnoses obtained during 2011-2013 for individuals aged 3-18 years were extracted. Descriptive statistics were used to examine difference in somatic morbidity between children with and without psychiatric diagnoses. Logistic regression was used in age-stratified models to test the association between psychiatric and somatic diagnoses. Anxiety and behavioral disorders were associated with all somatic conditions investigated at nearly all ages. The same applied to substance use, investigated at age 9-18 years. Affective disorders were associated with all somatic conditions at age 12-18 years. Psychotic conditions were associated with asthma, bowel disorders and myalgia in adolescents. Children with psychiatric disorders are at remarkably high risk for concurrent somatic illness. The associations span across many types of conditions and across all ages. The results support the need for awareness of somatic morbidity in child and adolescent psychiatric clinical settings, and the need for coordinated health care for children with comorbid states.Funding Agencies|Research and Development Sodra Alvsborg</p

“…or else I close my ears” How women with obesity want to be approached and treated regarding gestational weight management : A qualitative interview study.

Introduction: The importance of helping pregnant women maintain a healthy lifestyle and prevent excessive gestational weight gain is well recognized, but pregnant women do not always perceive communication about body weight as respectful or helpful. Furthermore, fear of inducing shame or guilt can prohibit some midwives from talking about body weight, especially if the woman has obesity. We aimed to explore what women of reproductive age with obesity regard to be the most important and relevant aspects when discussing gestational weight management. Methods: Qualitative interview study using focus groups and individual semi-structured interviews with 17 women of reproductive age (19–39 y) with obesity. Thematic analysis was used to analyze the data. Results: We identified three themes: 1) Importance of obtaining vital medical information; 2) A wish to feel understood and treated with respect; 3) Midwives’ approach is crucial in sensitive key situations, which include bringing up the subject of body weight, weighing, providing weight-related information, coaching lifestyle modification, dealing with emotional reactions and ending a conversation. Conclusions: A majority of the interviewed women wished to receive information about risks about obesity and gestational weight gain, and recommendations on weight management. However, the risk of midwives offending someone by raising the topic may be increased if the pregnant woman believe that gestational weight gain is uncontrollable by the individual. Also, several situations during maternity care meetings can be stigmatizing and make women less receptive to advice or support. Women suggest that a good working alliance is likely to be achieved if midwives have knowledge about the causes of obesity, take interest in the patients’ background, have a non-judgmental approach and refrain from giving unsolicited advice.

Women's Perceived Reasons for Their Excessive Postpartum Weight Retention: A Qualitative Interview Study.

Obesity in Sweden has doubled to 14% over the last 20 years. New strategies for treatment and prevention are needed. Excessive gestational weight gain has been found to contribute substantially to obesity, and there is a consistent association between postpartum weight retention and obesity later in life. We aimed to explore what factors women perceive as reasons for having substantial postpartum weight retention, to identify areas for new and improved interventions.Qualitative interview study (semi-structured) using an emergent design. Fifteen women, with a postpartum weight retention ≥ 10 kg, were interviewed by a trained cognitive therapist. Eight women had pre-pregnancy BMI below 30 kg/m2. Interviews were transcribed verbatim and data analysed using inductive manifest content analysis. Salient text passages were extracted, shortened, coded and clustered into categories.Participants reported no knowledge of current gestational weight gain recommendations or of risks for adverse pregnancy outcomes with excessive weight gain or postpartum weight retention. Excessive eating emerged as a common strategy to provide relief of psychological, emotional and physical discomfort, such as depression and morning sickness. Women perceived medical staff as being unconcerned about weight, and postpartum weight loss support was scarce or absent. Some women reported eating more due to a belief that breastfeeding would automatically lead to weight loss.There is a need to raise awareness about risks with unhealthy gestational weight development and postpartum weight retention in women of childbearing age. The common strategy to cope with psychological, emotional or physical discomfort by eating is an important factor to target with intervention. The postpartum year is a neglected period where additional follow-up on weight and weight loss support is strongly indicated

Weight loss, adverse events, and loss to follow-up after gastric bypass in young versus older adults : A Scandinavian Obesity Surgery Registry study.

BACKGROUND: Young adults display particularly poor weight loss in behavioral obesity treatment; nonetheless, they have seldom been included in bariatric research. OBJECTIVES: To compare weight loss, adverse events, and loss to follow-up in young (18-25 yr) versus older (≥26 yr) adults up to 5 years after Roux-en-Y gastric bypass. SETTING: Nationwide, register-based study, Sweden. METHODS: Prospective registry data (Scandinavian Obesity Surgery Register) were analyzed in young (22.2 yr [standard deviation (SD): 2.1], 81.6% women, mean body mass index 43.7 kg/m2 [SD: 5.4]) and older (42.6 years [SD: 9.6], 82.0% women, mean body mass index 43.4 kg/m2 [SD: 5.0]) adults undergoing Roux-en-Y gastric bypass. Groups were matched for body mass index, sex, and year of surgery. Regression analyses and mixed models were used to compare outcomes between groups. RESULTS: A total of 369 young (37.0% of eligible) and 2210 older (46.1%) adults attended the 5-year follow-up. At this time, weight loss was 31.8% in young and 28.2% in older adults (P &lt; .001), with a serious adverse event (Clavien-Dindo ≥3b) being reported in 52 (14.1%) young and 153 (6.9%) older adults (odds ratio = 2.06, 95% confidence interval: 1.45-2.92, P &lt; .001). Loss to follow-up was higher in young versus older adults throughout the study period (range of relative risk = 1.16-1.89, P &lt; .001). CONCLUSIONS: While young adults displayed at least equal weight loss as older adults, rates of adverse events were approximately doubled, and loss to follow-up rates were higher. Future studies on the significance of and the etiology behind the higher incidence of serious adverse events are needed. Intensified clinical contact post Roux-en-Y gastric bypass should have the potential to further improve outcomes in young adults

Health care utilization in children and adolescents with psychiatric disorders

Objective: Mental illness is increasing among young people and likewise the request for health care services. At the same time, somatic comorbidity is common in children and adolescents with psychiatric disorders. There is a lack of studies on health care use in children and adolescents, and the hypothesis was that children and adolescents with psychiatric disorders use more primary-, and specialized somatic health care compared to children without psychiatric disorders. Methods: In this retrospective population-based register study, all individuals aged 3-17 years living in Vastra Gotaland region in Sweden in 2017 were included (n = 298,877). Linear and Poisson regression were used to compare health care use during 2016-2018 between children with and without psychiatric diagnoses, controlling for age and gender. The results were reported as unstandardised beta coefficient (beta) and adjusted prevalence ratio (aPR) respectively. Results: Having a psychiatric diagnosis was associated with more primary care visits (beta 2.35, 95% CI 2.30-2.40). This applied to most diagnoses investigated. Girls had more primary care visits than boys. Likewise, individuals with psychiatric diagnoses had more specialized somatic outpatient care (beta 1.70, 95% CI 1.67-1.73), both planned and unplanned (beta 1.23, 95% CI 1.21-1.25; beta 0.18, 95% CI 0.17-0.19). Somatic inpatient care was more common in those having a psychiatric diagnosis (aPR 1.65, 95% CI 1.58-1.72), with the diagnoses of psychosis and substance use exerting the greatest risk. Conclusions: Psychiatric diagnoses were associated with increased primary-, somatic outpatient- as well as somatic inpatient care. Increased awareness of comorbidity and easy access to relevant health care could be beneficial for patients and caregivers. The results call for a review of current health care systems with distinct division between medical disciplines and levels of health care.Funding Agencies|Research and Development Sodra Alvsborg</p