See https://www.fda.gov/ForIndustry/Developing ProductsforRareDiseasesConditions/default.htm.Family-based psychotherapies have a robust evidence base of efficacy for treating younger patients, and adults often do well with cognitivebehavioral approaches delivered by experienced subspecialists. But refractory patients, who comprise a large number of the affected adult population, are extraordinarily difficult to treat.

Objective-This study compared an objective measurement of physical activity (PA) in individuals with anorexia nervosa (AN) at low-weight, weight-restored, and post-treatment time points, and also compared PA in AN with that of healthy controls (HC).Method-Sixty-one female inpatients with AN wore a novel accelerometer (the IDEEA) which measured PA at three time points: a) low-weight, b) weight-restored, and c) one month posthospital discharge. Twenty-four HCs wore the IDEEA at one time point.Results-Inpatients with AN became more physically active than they were at low-weight at weight restoration and following treatment discharge. Post-treatment patients with AN were more physically active than HCs during the day and less active at night, which was primarily accounted for by amount of time spent on feet, including standing and walking. Greater time spent on feet during the weight-restoration time point of inpatient treatment was associated with more rapid decrease in BMI over the 12 months following treatment discharge. Fidgeting did not differ between patients and controls, did not change with weight restoration, and did not predict posttreatment weight change.Discussion-Use of a novel accelerometer demonstrated greater PA in AN than in healthy controls. PA following weight restoration in AN, particularly time spent in standing postures, may contribute to weight loss in the year following hospitalization. Keywords Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptAnorexia Nervosa (AN) is a serious psychiatric illness marked by self-starvation and overvaluation of shape and weight. There has been a longstanding interest in the role of physical activity (PA) in the etiology, maintenance, and prognosis of AN. A range of methods has been used to assess PA in AN, from subjective patient report of exercise frequency and drive to exercise, to objective devices such as accelerometers, which can quantify the frequency and duration of PA.Despite low weight, a significant subset of individuals with AN report that they engage in "excessive" or "compulsive" exercise (1), with one of the earliest clinical observations of a patient with AN by Dr. William Gull from 1868 noting that despite extremely low weight, the patient was "restless and active...it seemed hardly possible that a body so wasted could undergo the exercise which seemed agreeable"(2). This elevated level of exercise is associated with heightened psychopathology, such as depression, anxiety, and eating disorder symptomatology (3-6). Compulsive exercise during treatment is also negatively associated with improvements in eating disorder pathology by treatment discharge (3) and subjective report of compulsive exercise is associated with long-term lack of recovery from AN (7).Notwithstanding the longstanding clinical observation of heightened PA in AN, investigation of objective activity levels in patients with AN has yielded mixed results. While some studies have found that patients with AN are more active than healthy controls (8), oth...

Our results demonstrate that FK506 effectively blocks the TGF-β/Smad signalling pathway in KFs by downregulation of TGF-β receptors and suggest that FK506 may be included in the armamentarium for treating keloids.

Background Anorexia nervosa (AN) is a life-threatening psychiatric disorder associated with significant medical and psychosocial impairment. Hospital-based behavioral treatment is an effective intervention in the short-term. However, relapse rates following discharge are high and thus, there is a need to identify predictors of longitudinal outcome. The current study provides information regarding illness course and health maintenance among patients with AN over 5 years following discharge from an eating disorder inpatient unit. Methods Participants were individuals with AN who were discharged from a specialized, inpatient behaviorally-based unit. Prior to discharge, height and weight were measured and participants completed self-report measures of eating disorder severity and general psychopathology (depression, anxiety, harm avoidance). Participants were contacted annually for self-report measures of weight, eating disorder severity and clinical impairment. Outcome was defined by illness course (body mass index (BMI) and clinical impairment during the 5 years) and health maintenance (categories of weight and eating disorder symptom severity) across follow-up, using all available data. Linear mixed models were used to examine whether demographic and clinical parameters at discharge predicted BMI and clinical impairment over time. Additional analyses examined whether these variables significantly influenced an individual’s likelihood of maintaining inpatient treatment gains. Results One-hundred and sixty-eight individuals contributed data. Higher trait anxiety at discharge was associated with a lower BMI during follow-up (p = 0.012). There was a significant interaction between duration of illness and time, whereby duration of illness was associated with a faster rate of weight loss (p = 0.003) during follow-up. As duration of illness increased, there was a greater increase in self-reported clinical impairment (p = 0.011). Increased eating disorder severity at discharge was also associated with greater clinical impairment at follow-up (p = 0.004). Higher BMI at discharge was significantly associated with maintaining healthy weight across a priori BMI-based definitions of health maintenance. Conclusions Weight status (higher BMI) and duration of illness are key factors in the prognosis of AN. Higher weight targets in intensive treatments may be of value in improving outcomes.

Aberrations in eating patterns constitute a substantial public health burden. Computer-based paradigms that measure responses to images of foods are potentially useful tools for assessing food attitudes and characteristics of eating behavior. In particular, food choice tasks attempt to directly probe aspects of individuals' decisions about what to eat. In the Food Choice Task participants rate the healthiness and tastiness of a variety of food items presented one at a time. Next, participants choose for each food item whether they prefer to eat the item vs. a neutrally rated reference food item. The goal of the current study was to assess the stability and reliability of this Food Choice Task over time and with repeated testing. Secondary analyses were conducted using data from healthy volunteers in two separate studies that administered the task at two time points, separated either by several days or about a month. The overall reliability of the Food Choice Task across multiple administrations was assessed using intra-class correlation coefficients and the reliability of ratings of individual food items was assessed using kappa coefficients. The results indicated that test-retest reliability of the Food Choice Task in healthy volunteers was high at both shorter and longer test-retest intervals. In addition, the reliability of individual food item ratings was good for a majority of items. The proportion of healthy volunteers' high-fat food choices did not change over time in either of the two studies. Thus, the Food Choice Task is suitable for measuring food choices in studies with multiple assessment points. In particular, the task may be well suited to assess restrictive eating, a construct which it has been difficult to assess in experimental settings.

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Objective: To evaluate the effect of beinaglutide on weight loss and plasma protein patterns of inflammation/obesity relevant cytokines and biomarkers. Materials and methods: This study involved 36 adult patients with a body mass index (BMI) of ≥ 24 kg/m 2 and T2DM. Beinaglutide was administered for three months. Changes in body weight, fasting plasma glucose (FPG) level, 2 h postprandial plasma glucose (2h-PG) level, glycosylated hemoglobin (HbA1c) level, BMI and visceral and subcutaneous fat areas were measured at baseline and after three months of treatment. In addition, relevant inflammation/obesity cytokines and biomarkers were measured. Results: After three months, beinaglutide treatment led to significant changes, including in body weight, BMI, FPG level, HbA1c level, visceral and subcutaneous fat areas. In addition, serpin E1, leptin, C-reaction protein (CRP) and tumor necrosis factor-α (TNF-α) also decreased significantly. The plasma protein concentrations of CRP (Log2 transformed) were found to be positively correlated with the percentage of weight loss (R = 0.514 and p -value = 0.021). Conclusion: Beinaglutide treatment resulted in weight loss, plasma glucose control and anti-inflammatory effects in patients with T2DM and overweight/ obesity.

The purpose of the current study was to examine the relative reinforcing effect of exercise compared to a non-monetary alternative reinforcer (leisure activity), and to money, before and after weight restoration in an inpatient population with anorexia nervosa (AN). Sixty-two inpatients with AN completed a progressive ratio (PR) task to earn exercise, leisure activities, or cash at low weight and after weight restoration. Measures of pathology and motivation to exercise were completed and post-treatment discharge weights were collected. Patients worked harder for exercise at low weight than after weight restoration (df = 46, t = 5.50, p < .001). PR task performance was weakly associated with a measure of commitment to exercise (low weight: r = 0.31, weight restored: r = 0.36, p < .05), but not with other clinical measures or follow-up weights. Contrary to prior suggestions, measurement of the reinforcing value of exercise among individuals with AN via a PR task does not appear valuable in assessing clinical severity or outcome. Other, simpler, self-report measures of commitment to exercise may have greater value in assessing these outcomes.