Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.

BACKGROUND: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. METHODS: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed. RESULTS: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months. CONCLUSION: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01448785.

Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study.

OBJECTIVE: To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity. METHODS: This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m-2) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann-Whitney's U-test. RESULTS: At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of -6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%; P<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (P<0.001). CONCLUSIONS AND RELEVANCE: This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.

Assessing the appropriateness of the level of care for morbidly obese subjects: validation of the CASCO-R scale.

AIM: Aim of this study was to validate the Comprehensive Appropriateness Scale for the Care of Obesity in Rehabilitation (CASCO-R) and to determine the cut-off score for indicating the most appropriate health care setting for patients with obesity. METHODS: The CASCO-R scale was developed according to the available scientific literature and expertise of an expert panel working for a Consensus document endorsed by the Italian Society of Obesity (SIO) and the Italian Society for the Study of Eating Disorders (SISDCA). 16 Italian centres, specialized in the treatment of obesity, characterised by different settings of care (specialist outpatient service, day-hospital service, intensive inpatient rehabilitation), participated in the study. RESULTS: 449 obese subjects were enrolled in the study (30.5% males and 69.5% females): 38.3% from outpatient services, 20.7% from day-hospital services and 40.9% from intensive inpatient rehabilitation units. After 2-month of treatment, a workload summary sheet, including medical and nursing interventions, number of expert advices and diagnostic procedures, and adverse clinical events (ACEs) was fulfilled for each patient. Statistically significant correlation was found between the CASCO-R scale score, overall workload and ACEs. The CASCO-R scale demonstrated also an excellent performance in terms of internal validity and test-retest analysis. Three total score cut-off have been proposed: >25 for inpatient intensive rehabilitation; 20-25 for day-hospital service; <20 for outpatient treatment. CONCLUSIONS: In conclusion, the CASCO-R scale was demonstrated to be a valid tool for assessing the appropriateness of the choice of the level of care. Hence, it can be used to verify the proper allocation of patients, as it was well correlated with measures of workload and the incidence of ACEs.

Absolute frequency measurement of the 40Ca+ 4s(2)S_(1/2)-3d(2)D_(5/2) clock transition.

We report on the first absolute transition frequency measurement at the 10;{-15} level with a single, laser-cooled 40Ca+ ion in a linear Paul trap. For this measurement, a frequency comb is referenced to the transportable Cs atomic fountain clock of LNE-SYRTE and is used to measure the 40Ca+ 4s ;{2}S_{1/2}-3d ;{2}D_{5/2} electric-quadrupole transition frequency. After the correction of systematic shifts, the clock transition frequency nu_{Ca;{+}}=411 042 129 776 393.2(1.0) Hz is obtained, which corresponds to a fractional uncertainty within a factor of 3 of the Cs standard. In addition, we determine the Landé g factor of the 3d;{2}D_{5/2} level to be g_{5/2}=1.200 334 0(3).

[Benefit from bio-enteric Intra-gastric balloon (BIB) to modify lifestyle and eating habits in severely obese patients eligible for bariatric surgery]. / Utilità del palloncino intragastrico nel modificare le abitudini di vita del paziente affetto da obesità severa, candidabile alla chirurgia bariatrica.

AIM: The therapeutic model for severe obesity includes bariatric surgery, representing the safest way to keep weight down and to prevent relapses. The selection of patients for the most suitable type of surgery implies multidisciplinary approach (nutritionist, dietist, clinical psychologist and surgeon). The intragastric balloon may represent a relatively invasive method to help the medical team to select and prepare severely obese patients for restrictive bariatric surgery. METHODS: In our study we considered 48 severely obese patients: initial weight 111+/-14.8 kg, BMI 43+/-5.02, excess weight 77.47+/-16.14%. These patients have been treated with intragastric balloon (BIB) filled to a volume of 500 cc for 6 months. We considered variations induced by BIB treatment on a number of parameters--clinical, anthropometric, food intake, partition of nourishing elements and psychological and psychometric data. RESULTS: At the end of the treatment the patients showed significant reductions of excess weight (67.35+/-20.19%), of weight (103.4+/-16.72 kg) and food intake, without modification of the items in the EDI2 test, but with important motivational support for a change in life style between the beginning and the end of the treatment, clearly resulting from the medical, dietist and clinical-psychological follow-up. CONCLUSIONS: BIB is a relatively invasive means capable of modifying eating habits in the short term; it induces weight loss, may help to reduce the anaesthesiological risk and to foster a change in the patient's behaviour. In our experience treatment with BIB is useful from the educational point of view and can be used to select patients for bariatric surgery only within a multidisciplinary team. Further clinical studies are necessary.

Baseline personality characteristics of responders to 6-month psychotherapy in eating disorders: preliminary data.

OBJECTIVE: The Karolinska Psychodynamic Profile (KAPP) was used for the assessment of the six-month outcome of Brief Adlerian Psychodynamic Psychotherapy (B-APP). METHOD: Fifty-seven eating disordered women (28 with anorexia nervosa, 29 with bulimia nervosa), were included in the study. The sample was evaluated at baseline (time 0) and after six months (T6) with a clinical assessment and with Temperament and Character Inventory (TCI), Eating Disorder Inventory (EDI-2), State-Trait Anger Expression Inventory (STAXI), and KAPP. RESULTS: Based on symptomatologic improvement, two sub-groups were obtained: responders (66.6%) and non-responders (33.3%). Significantly higher baseline scores emerged in the responders group on Ineffectiveness and Impulsivity (EDI-2) and on Harm Avoidance (TCI). Several KAPP items and areas improved in both groups at T6. CONCLUSION: Multimodal treatment centered on B-APP lead to both a global clinical improvement and an improvement in several psychological and psychopathological features as assessed by EDI-2, STAXI and KAPP. The results suggest interesting clinical implications, though outcome predictors are quite weak.

Prolonged treatment with glycerophosphocholine, an acetylcholine precursor, does not disclose the potentiating effect of cholinesterase inhibitors on GHRH-induced somatotroph secretion in anorexia nervosa.

Unlike normal subjects, in patients with anorexia nervosa (AN) the GH response to GHRH is refractory to the increasing and inhibitory effect of cholinergic agonists and antagonists, respectively. This cholinergic impairment could reflect malnutrition-induced exhaustion of acetylcholine (Ach) precursors. We studied whether treatment with glycerophosphocholine (GLY), an Ach precursor, could disclose the potentiating effect of pyridostigmine (PD) on the GH response to GHRH in AN. In 6 young women with AN (AW) we studied the GH response to iv GHRH (1.0 microg/kg) alone and combined with oral PD (120 mg) before and after 1 month of oral treatment with GLY (400 mg thrice daily). Eight age-matched normal women (NW) were studied as controls. Before GLY, basal GH levels in AW were higher (p < 0.05) than in NW. The GH response to GHRH in AW was higher (p < 0.05) than in NW. PD failed to modify the GHRH-induced GH rise in AW, while it enhanced it in NW (p < 0.05). One month treatment with GLY in AW did not modify the GH response to GHRH either alone or combined with PD. This study shows the existence of a derangement in the cholinergic control of somatotroph function in AN and indicates that treatment with Ach precursors does not exert any effect on this impairment. This could reflect primary alterations of cholinergic neurons, though the effectiveness of more prolonged treatment and/or higher doses of cholinergic precursors needs to be verified.

Combining the Rorschach test and the Temperament Character Inventory: a new perspective on personality assessment.

BACKGROUND: The numerous reports on research involving the clinical assessment of personality in axis I disorders highlight the importance of temperament features in the current approach to all mental disorders. However, the available instruments of personality assessment have many limits. Self-administered questionnaires depend on the patient's insight, and projective instruments (i.e. the Rorschach test) often lack objectivity. This study compared the results of personality assessment with the Temperament and Character Inventory (TCI) and the Rorschach test to verify their validity. PATIENTS AND METHODS: TCI and Rorschach tests were administered to a wide sample of patients (n = 180) in a short period. The most common Rorschach siglatures were correlated with the TCI raw scores using the Pearson correlation test. RESULTS: All TCI temperament dimensions and facets displayed at least two correlations with Rorschach siglatures. The description of each dimension and facet of the TCI obtained with the interpretation of Rorschach siglatures was consistent with its original meaning. CONCLUSIONS: The TCI and Rorschach tests adequately validated each other. In the future, the administration and integration of these tests will overcome the biases of both. Further, the theoretical bases of the TCI could facilitate the study of psychological functions, whereas the psychodynamic bases of the Rorschach test provide an in-depth insight into temperament traits.

Bulimic family dynamics: role of parents' personality--a controlled study with the Temperament and Character Inventory.

The numbers of studies on the familial environment and personality of bulimic women have increased in recent years and results have revealed interesting features. In this study, we evaluated the temperament and character traits of patients with bulimia nervosa (BN) and their mothers and fathers, and we analyzed the correlation of temperament and character traits among members of these bulimic families. Finally, we tested the ability of the Temperament and Character Inventory (TCI) to discriminate between normal controls and bulimic subjects, their parents, and their families. Using the TCI, temperament and character features of 28 bulimic patients and their parents (23 fathers and 28 mothers) were analyzed and then compared with a control group of 29 women and their 27 fathers and 29 mothers. Data suggest that both temperament and character factors are involved in BN. Bulimic individuals were high in harm avoidance and low in self-directedness. Their mothers were distinguished by low self-directedness. The fathers were low in persistence. Harm avoidance of bulimic women positively correlated with harm avoidance and negatively with self-directedness of their mothers. The bulimic family had low self-directedness as a common denominator observed in all family members. The observation that both temperament and character have important roles in the etiopathogenesis of bulimia nervosa has important treatment ramifications. The TCI was useful in discriminating between normal controls and bulimic subjects, their parents, and the whole family.

Dropout from brief psychotherapy in anorexia nervosa.

BACKGROUND: Dropout from psychotherapy is an important issue that has received little systematic attention. This study investigated the phenomenon of dropout from brief psychotherapy for anorexia nervosa (AN). METHODS: 99 outpatients suffering from AN of the restrictor type (n = 53) or binge/purging type (n = 46) were evaluated. Their clinical and personal characteristics were recorded, and body mass index was calculated for participants. They were administered the Eating Disorder Inventory-II (EDI-II), the State-Trait Anger Expression Inventory (STAXI) and the Temperament and Character Inventory (TCI). RESULTS: Significant differences in some baseline psychopathologic (EDI-II, STAXI) and personality (TCI) variables emerged from the comparison between dropouts and completers. Patients who dropped out of the treatment showed higher levels of anger temperament, anger expression-in and expression-out and lower scores for the dimensions of character (low self-directedness and low cooperativeness). No differences were found between the two groups regarding sociodemographic and clinical variables. CONCLUSIONS: Dropout from brief psychotherapy seems to be related to either psychopathologic or personality aspects, such as the tendency to repress anger, which is encountered also in psychosomatic disorders, and the presence of more compromised dimensions of character, typical of subjects with personality disorders. This study of dropout from brief psychotherapy in AN provided interesting results that will need further confirmation. Possible implications for treatment are addressed.

Anger and personality in eating disorders.

OBJECTIVE: This study was designed to examine how anger, temperament and character profiles differ across subtypes of eating disorders (EDs) in comparison to healthy controls and to analyze the relationship between anger expression, eating attitudes and personality dimensions. METHOD: One hundred and thirty-five outpatients (50 of whom suffered from anorexia nervosa restrictor type [AN-R], 40 from anorexia nervosa binge/purging [AN-BP] and 45 from bulimia nervosa [BN]) and 50 control subjects were recruited and administered State-Trait Anger Expression Inventory (STAXI), Temperament and Character Inventory (TCI) and Eating Disorder Inventory II (EDI-II). RESULTS: STAXI showed greater levels of anger in patients with BN than in those with AN. TCI showed different personality profiles, in accordance with previous studies. Correlations were found between the management of anger feelings and psychological and personality traits typical of patients with EDs. CONCLUSIONS: Clinically, impulsivity seems to be the psychopathologic element most strongly correlated to anger. Moreover, it appears clear that anger is better managed by individuals with greater character strength.

Outcome predictors in anorectic patients after 6 months of multimodal treatment.

BACKGROUND: Anorexia nervosa is a severe disorder that often responds poorly to treatment. At this time, little is known about pretreatment predictors of response. METHODS: A sample of 42 restrictor type anorectics was tested at the assessment phase and after 180 days retested using the Temperament and Character Inventory and Eating Disorder Inventory 2 along with other clinical evaluation instruments. After 180 days of treatment with multimodal 'network' therapy, the patients were divided into two groups. The first group included patients who showed relevant clinical improvement; the second group included patients considered 'not yet responding'. Data collected from the not-yet-responding group were compared by the t test with the other group's data to evaluate prognostic indexes. RESULTS: Diagnosis of personality disorder, which afflicted about 50% of patients, seemed not to be a relevant prognostic factor. However, a lower novelty seeking was characteristic of the nonresponder group. Higher levels of asceticism and maturity fears also characterized the nonresponder group. CONCLUSION: Present data suggest some elements that could be useful to focus pharmacotherapy, psychotherapy and family counseling on the current psychopathology of each patient.

Temperament and character in italian men with anorexia nervosa: a controlled study with the temperament and character inventory.

This study compares personality traits of men and women with anorexia nervosa and matched controls. The Temperament and Character Inventory was used to assess personality traits of 15 male and 50 female anorectics and 28 male and 58 female controls matched for age and education. Male anorectic patients displayed overall lower reward dependence and cooperativeness. Male and female anorectics displayed higher persistence and lower self-directedness than controls. Anorectic men had lower harm avoidance than anorectic women. Discriminating analysis revealed the anorectic male group as the most clearly defined. Anorectic men shared more traits with anorectic women than with male controls. Temperament and character of anorectic men reflect features partly similar to those of women with anorexia. Personal history and discriminating analysis led to interesting inferences about the gender identity of anorectic men. These results should be helpful in directing pharmacologic and psychotherapeutic approaches that consider the specific personality traits of these patients.

Nonresponder anorectic patients after 6 months of multimodal treatment: predictors of outcome.

Currently the therapy of anorexia nervosa is a relevant clinical problem. The percentage of patients who respond to short-term pharmacotherapy and psychotherapy is still low and the condition often leads to chronic pathology or death. The present study aims to determine outcome predictors beyond personality traits, eating psychopathology, or particular clinical features. Forty patients with restricter type anorexia nervosa were tested, at T0 and after 180 days, with psychometric tests and clinical evaluation instruments. Patients were then divided into two groups. One group included patients who showed relevant clinical improvement; the other included not-yet-improved patients. A lower Novelty Seeking, higher levels of Ascetism and Maturity Fears characterised the not-yet-improved group. Correlation showed evidence of diverse bonds between personality and psychopathology in the improved and not-yet-improved groups. The psychopathology of non-yet-improved patients seemed to be more linked to their temperamental features, whereas improved patients seemed to be more influenced by their character. Different levels of psychological functioning can be expressed. The present data suggest focusing pharmacotherapy and psychotherapy, even family counseling, with a progression more strictly related to the current personality functioning level and psychopathology of each patient.

Evidence for a positive correlation between serum cortisol levels and IL-1beta production by peripheral mononuclear cells in anorexia nervosa.

A hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis has been reported in anorexia nervosa (AN), together with some immunological abnormalities, involving citokine - and particularly Tumor Necrosis-Factor-alpha (TNF-alpha) - production by polymorphonuclear cells. The ability of pro-inflammatory cytokines to activate the HPA axis is well known; however, there are no data demonstrating an interdependence between immunological and endocrine response in AN. To investigate the presence of a correlation between immune response and pituitary-adrenal function, plasma ACTH and serum cortisol concentrations were measured in 13 AN patients and in the same number of controls. TNF-alpha and interleukin (IL)-1beta production by ex-vivo unstimulated and LPS-stimulated peripheral mononuclear cells was also assessed. Circulating cortisol concentrations were higher (p<0.01) in AN (156.7 +/- 45.1 microg/l, mean +/- SD) than in controls (105.9 +/- 25.7 microg/l). Unstimulated IL-1beta release in supernatants of mononuclear cell cultures was slightly but not significantly higher in AN than in controls, while TNF-alpha release was similar in the two groups. A positive correlation was found between IL-1beta concentrations in unstimulated culture supranatants and serum cortisol levels in AN (r=0.782, p=0.002), while in normal subjects there was a trend toward a negative correlation; a slight positive correlation, while not significant, between IL-1beta and plasma ACTH, as well as between TNF-alpha and serum cortisol was also found in AN. These data suggest that the normal relationship between pro-inflammatory cytokines release, particularly IL-1beta, and cortisol secretion is deranged in AN.

Performances of OsO(4) stabilized CO(2) lasers as optical frequency standards near 29 THz.

In this paper, we report on the metrological capabilities of CO (2)/OsO(4) optical frequency standards operating around 29 THz. Those frequency standards are currently involved in various fields, such as frequency metrology, high resolution spectroscopy, and Rydberg constant measurements. The most impressive features of the standards lies in the 10(-15) level frequency stability allied to a long-term reproducibility (1 yr) of 1.3x10 (-13).

Construction and evaluation of the first Brazilian atomic clock.

For the past two years we have been implementing a program for the establishment of scientific time and frequency metrology in Brazil. The main objective of this program is to construct an atomic fountain and use it as a primary standard. As a first step toward this goal, we have constructed a (133)Cs beam optically pumped conventional clock. In this paper we describe the system and the results of its evaluation. The possible limitations of our short-term stability are discussed.

Quantitation of leukemia clone-specific antigen gene rearrangements by a single-step PCR and fluorescence-based detection method.

PCR-based detection of minimal residual disease (MRD) in children with precursor B cell acute lymphoblastic leukemia (pre-B ALL) by amplification of clone-specific antigen gene rearrangements has been labor-intensive. In this study we present a simpler, yet accurate, method to assess and quantitate MRD in pediatric pre-B ALL that utilizes these markers. From the sequence of the immunoglobulin heavy chain (IgH) and T cell receptor (TcR) gene rearrangements characterized at the time of diagnosis or relapse, primers were designed and tested in a clone-specific, single-round PCR assay, then analyzed by fluorescence staining of the PCR products. The most critical step involved an adherence to a new set of guidelines for the design of clone-specific primers. Application of this method to 54 IgH and 13 TcR (nine Vdelta2Ddelta3 and four Ddelta2-Ddelta3) gene rearrangements in 47 patients resulted in an intense band within the region of the predicted molecular weight, confirming the reproducibility of the assay. Quantitative applications of the approach were examined by performing a 10-replicate limiting dilution clone-specific PCR on six diagnostic samples and an asymptotic response model of the Von Krogh form was found to fit the data well. From this model, estimation of leukemic cells of remission bone marrow samples was achieved at a detection sensitivity of 2 x 10(-6). The method is demonstrated on 18 patients whose marrows were prospectively analyzed during therapy. We conclude this methodology is useful in the quick and accurate assessment of MRD in children with pre-B ALL, and could be applied to other DNA quantitation assays.