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Consensus opinion from an international group of experts on measurable residual disease in hairy cell leukemia.
Ravandi, F, Kreitman, RJ, Tiacci, E, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, SA, Blachly, JS, Broccoli, A, Call, T, et al
Blood cancer journal. 2022;(12):165
Abstract
A significant body of literature has been generated related to the detection of measurable residual disease (MRD) at the time of achieving complete remission (CR) in patients with hairy cell leukemia (HCL). However, due to the indolent nature of the disease as well as reports suggesting long-term survival in patients treated with a single course of a nucleoside analog albeit without evidence of cure, the merits of detection of MRD and attempts to eradicate it have been debated. Studies utilizing novel strategies in the relapse setting have demonstrated the utility of achieving CR with undetectable MRD (uMRD) in prolonging the duration of remission. Several assays including immunohistochemical analysis of bone marrow specimens, multi-parameter flow cytometry and molecular assays to detect the mutant BRAF V600E gene or the consensus primer for the immunoglobulin heavy chain gene (IGH) rearrangement have been utilized with few comparative studies. Here we provide a consensus report on the available data, the potential merits of MRD assessment in the front-line and relapse settings and recommendations on future role of MRD assessment in HCL.
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Mechanism for the Increase in Human Growth Hormone with Administration of a Novel Test Supplement and Results Indicating Improved Physical Fitness and Sleep Efficiency.
Heaton, AL, Kelly, C, Rood, J, Tam, CS, Greenway, FL
Journal of medicinal food. 2021;(6):653-659
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Abstract
An oral test supplement increases serum human growth hormone (hGH) levels after acute administration in healthy adults. We investigated the mechanism for the increase in hGH and the effect of continued daily administration of the test supplement on measures of physical fitness and sleep efficiency. In Study 1, serum triiodothyronine (T3) was measured in samples from a prior placebo-controlled, double-blind study in which 16 healthy participants received both placebo and the test supplement in a crossover design; treatment order was randomized, and treatments were separated by a 1-week washout. In Study 2, physical fitness (VO2 max) was measured at baseline and after 2 weeks of daily administration of the test supplement (N = 12 healthy participants). Study 3 assessed daily sleep onset latency and time awake during 3 weeks of daily administration of the test supplement (N = 15 healthy participants). A fall from baseline in T3 was observed with placebo (-6.1 ± 8.5 ng/dL, P = .01). Of note, the change in T3 was smaller with the test supplement (-3.3 ± 10.7 ng/dL, P = not significant) but was not statistically different from placebo. Mean VO2 max increased by 6% from baseline after 2 weeks (P = .02). Sleep-onset latency and time awake during the night were reduced from baseline to week 3 by 22% and 65%, respectively (P = .01 and P = .02). The conservation of T3 levels suggests that the mechanism for increased hGH secretion by the test supplement is through somatostatin inhibition. Furthermore, pilot studies indicated that daily administration of the supplement improved physical fitness and sleep efficiency from baseline, effects consistent with increased endogenous hGH release. Clinical Trial Registration No. NCT02987868.
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Hairy cell leukemia and COVID-19 adaptation of treatment guidelines.
Grever, M, Andritsos, L, Banerji, V, Barrientos, JC, Bhat, S, Blachly, JS, Call, T, Cross, M, Dearden, C, Demeter, J, et al
Leukemia. 2021;(7):1864-1872
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Abstract
Standard treatment options in classic HCL (cHCL) result in high response rates and near normal life expectancy. However, the disease itself and the recommended standard treatment are associated with profound and prolonged immunosuppression, increasing susceptibility to infections and the risk for a severe course of COVID-19. The Hairy Cell Leukemia Foundation (HCLF) has recently convened experts and discussed different clinical strategies for the management of these patients. The new recommendations adapt the 2017 consensus for the diagnosis and management with cHCL to the current COVID-19 pandemic. They underline the option of active surveillance in patients with low but stable blood counts, consider the use of targeted and non-immunosuppressive agents as first-line treatment for cHCL, and give recommendations on preventive measures against COVID-19.
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Increased Human Growth Hormone After Oral Consumption of an Amino Acid Supplement: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Study in Healthy Subjects.
Tam, CS, Johnson, WD, Rood, J, Heaton, AL, Greenway, FL
American journal of therapeutics. 2020;(4):e333-e337
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Abstract
BACKGROUND Human growth hormone (hGH) is best known for influencing bone and muscle growth, as well as body composition, but the use of recombinant hGH is controversial. Amino acids are a potentially safer alternative; however, preliminary investigations of the effects of oral amino acids on hGH release have been inconclusive. Therefore, we tested the effects of a novel blend of amino acids optimized to increase hGH release. STUDY QUESTION Does an investigational amino acid supplement affect hGH release? STUDY DESIGN This was a randomized, placebo-controlled, double-blind, crossover study that included 16 (12 men, 4 women; age 32 ± 14 years; body mass index 26.4 ± 5.0 kg/m) healthy participants. All participants received both placebo and the amino acid supplement after an overnight fast and completed all study visits. Treatment order was randomized, and each treatment was separated by a 1-week washout period. MEASURES AND OUTCOMES The primary outcomes were the percent change in hGH from baseline to 120 minutes and the area under the curve of hGH over baseline. Serum hGH was measured using enzyme-linked immunosorbent assay at baseline and 15, 30, 60, 90, and 120 minutes. RESULTS At 120 minutes, hGH levels increased by 682% (8-fold) from baseline and were significantly higher than placebo (P = 0.01). In addition, a significantly higher mean area under the curve was observed for the amino acid supplement compared with the placebo [20.4 (95% confidence interval, 19.9-21.0 ng/mL) vs. 19.7 (95% confidence interval, 18.7-20.6 ng/mL); P = 0.04]. CONCLUSIONS These results show that a single dose of the oral amino acid supplement was sufficient to significantly increase hGH levels in healthy adult men and women. CLINICAL TRIAL REGISTRY clinicaltrials.gov NCT01540773.
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Does weight cycling promote obesity and metabolic risk factors?
Mackie, GM, Samocha-Bonet, D, Tam, CS
Obesity research & clinical practice. 2017;(2):131-139
Abstract
BACKGROUND There remains common belief in the general community that weight cycling or 'yo-yo dieting' is associated with potential adverse effects on obesity and metabolic risk factors. In 1994, a review by the National Task Force on the Prevention and Treatment of Obesity concluded that weight cycling did not impact metabolism, and that weight loss attempts should not be discouraged. This study is an updated review of the literature published since 1994, to determine if weight cycling is associated with metabolic risk factors for obesity and type 2 diabetes. METHODS A systematic literature search was conducted in PubMed, ISI Web of Science and SCOPUS to identify primary studies that examined weight cycling in relation to obesity and metabolic risk factors. Thirty-one studies with human subjects were retained. RESULTS Fifty-eight percent (11/19) of publications reported that a history of weight cycling was correlated with increased body fat and central adiposity. Another fifty percent (4/8) of studies reported that the presence of weight cycling increased the likelihood of future weight gain, suggesting that weight cycling is potentially problematic for individuals attempting to lose weight. The majority of studies (13/17; 76%) did not show a detrimental effect of weight cycling on risk of type 2 diabetes. CONCLUSIONS There is some evidence showing that weight cycling has no effect on risk of type 2 diabetes and inconclusive evidence that a history or presence of weight cycling influences body composition, or predisposes to future obesity. The available evidence so far suggests that there is little detrimental effect of weight cycling on current and future obesity and metabolic risk, and therefore weight loss efforts in individuals with overweight/obesity should continue to be encouraged.
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Energy Metabolic Adaptation and Cardiometabolic Improvements One Year After Gastric Bypass, Sleeve Gastrectomy, and Gastric Band.
Tam, CS, Redman, LM, Greenway, F, LeBlanc, KA, Haussmann, MG, Ravussin, E
The Journal of clinical endocrinology and metabolism. 2016;(10):3755-3764
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CONTEXT It is not known whether the magnitude of metabolic adaptation, a greater than expected drop in energy expenditure, depends on the type of bariatric surgery and is associated with cardiometabolic improvements. OBJECTIVE To compare changes in energy expenditure (metabolic chamber) and circulating cardiometabolic markers 8 weeks and 1 year after Roux-en-y bypass (RYGB), sleeve gastrectomy (SG), laparoscopic adjustable gastric band (LAGB), or a low-calorie diet (LCD). Design, Setting, Participants, and Intervention: This was a parallel-arm, prospective observational study of 30 individuals (27 females; mean age, 46 ± 2 years; body mass index, 47.2 ± 1.5 kg/m2) either self-selecting bariatric surgery (five RYGB, nine SG, seven LAGB) or on a LCD (n = 9) intervention (800 kcal/d for 8 weeks, followed by weight maintenance). RESULTS After 1 year, the RYGB and SG groups had similar degrees of body weight loss (33-36%), whereas the LAGB and LCD groups had 16 and 4% weight loss, respectively. After adjusting for changes in body composition, 24-hour energy expenditure was significantly decreased in all treatment groups at 8 weeks (-254 to -82 kcal/d), a drop that only persisted in RYGB (-124 ± 42 kcal/d; P = .002) and SG (-155 ± 118 kcal/d; P = .02) groups at 1 year. The degree of metabolic adaptation (24-hour and sleeping energy expenditure) was not significantly different between the treatment groups at either time-point. Plasma high-density lipoprotein and total and high molecular weight adiponectin were increased, and triglycerides and high-sensitivity C-reactive protein levels were reduced 1 year after RYGB or SG. CONCLUSIONS Metabolic adaptation of approximately 150 kcal/d occurs after RYGB and SG surgery. Future studies are required to examine whether these effects remain beyond 1 year.
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Raised FGF-21 and Triglycerides Accompany Increased Energy Intake Driven by Protein Leverage in Lean, Healthy Individuals: A Randomised Trial.
Gosby, AK, Lau, NS, Tam, CS, Iglesias, MA, Morrison, CD, Caterson, ID, Brand-Miller, J, Conigrave, AD, Raubenheimer, D, Simpson, SJ
PloS one. 2016;(8):e0161003
Abstract
UNLABELLED A dominant appetite for protein drives increased energy intake in humans when the proportion of protein in the diet is reduced down to approximately 10% of total energy. Compensatory feeding for protein is apparent over a 1–2 d period but the mechanisms driving this regulation are not fully understood. Fibroblast growth factor-21 (FGF-21) has been identified as a candidate protein signal as levels increase in the circulation when dietary protein is low. The aim of this randomised controlled trial was to assess whether changes in percent dietary protein over a 4 d ad libitum experimental period in lean, healthy participants influenced energy intake, metabolic health, circulating FGF-21 and appetite regulating hormones including ghrelin, glucagon like peptide-1 and cholecystokinin. Twenty-two lean, healthy participants were fed ad libitum diets containing 10, 15 and 25% protein, over three, 4 d controlled, in-house experimental periods. Reduced dietary protein intake from 25% to 10% over a period of 4 d was associated with 14% increased energy intake (p = 0.02) as previously reported, and a 6-fold increase in fasting circulating plasma FGF-21 levels (p<0.0001), a 1.5-fold increase in serum triglycerides (p<0.0001), and a 0.9-fold decrease in serum total cholesterol (p = 0.02). Serum HDL cholesterol was reduced with a reduction in dietary protein from 15% to 10% (p = 0.01) over 4 d but not from 25% to 10% (p = 0.1) and the change from baseline was not different between diets. Plasma fasting insulin levels following the 4 d study period were significantly lower following the 25% ad libitum study period compared to the 15% protein period (p = 0.014) but not the 10% protein period (p = 0.2). Variability in interstitial glucose during each study period increased with a decrease in dietary protein from 25% to 15% and 10% (p = 0.001 and p = 0.04, respectively). Ghrelin, glucagon-like peptide-1 and cholecystokinin were unchanged. Increases in energy intake, plasma FGF-21 and serum triglycerides were associated with reductions in percent dietary protein from 25% to 10% energy over a 4 d ad libitum in-house feeding period and may be important in regulation of dietary protein intake. TRIAL REGISTRATION Australia New Zealand Clinical Trials Registry ACTRN12616000144415.
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No effect of caloric restriction on salivary cortisol levels in overweight men and women.
Tam, CS, Frost, EA, Xie, W, Rood, J, Ravussin, E, Redman, LM
Metabolism: clinical and experimental. 2014;63(2):194-8
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Alterations in normal cortisol patterns have been observed in people who are obese. The effect of weight loss on cortisol levels, a measure of hypothalamic pituitary adrenal (HPA) activity, in overweight individuals is not known. The aim of this study was to test the hypothesis that 6 months of moderate caloric restriction would alter morning and diurnal salivary cortisol levels. Thirty-five overweight adults (average BMI 27.8 kg/m2) took part in this randomised control trial. Participants were assigned to either calorie restriction (CR: 25% reduction in energy intake), calorie restriction+exercise (CR+EX: 12.5% reduction in energy intake+12.5% increase in exercise energy expenditure) or control (healthy weight-maintenance diet) for 6 months. Salivary cortisol was measured at 8:00, 8:30, 11:00, 11:30, 12:30, 13:00, 16:00 and 16:30. Morning cortisol was defined as the mean cortisol concentration at 08:00 and 08:30. Diurnal cortisol was calculated as the mean of the 8 cortisol measures across the day. Across all groups, higher morning and diurnal cortisol levels were associated with impaired insulin sensitivity. There was no significant effect of group, time or sex on morning or diurnal cortisol levels. The authors concluded that a 10% weight loss with a 25% CR diet alone or with exercise did not impact morning or diurnal salivary cortisol levels in overweight individuals. Their findings suggest that prolonged restriction of energy intake is not perceived by the body as a stressor, and therefore CR may present a viable intervention.
Abstract
OBJECTIVE The effect of weight loss by diet or diet and exercise on salivary cortisol levels, a measure of hypothalamic pituitary adrenal activity, in overweight individuals is not known. The objective was to test the hypothesis that 24 weeks of moderate caloric restriction (CR) (25%) by diet or diet and aerobic exercise would alter morning and diurnal salivary cortisol levels. DESIGN AND SETTING Randomized control trial in an institutional research center. PARTICIPANTS Thirty-five overweight (BMI: 27.8±0.7 kg/m(2)) but otherwise healthy participants (16 M/19 F). INTERVENTION Participants were randomized to either calorie restriction (CR: 25% reduction in energy intake, n=12), calorie restriction+exercise (CR+EX: 12.5% reduction in energy intake+12.5% increase in exercise energy expenditure, n=12) or control (healthy weight-maintenance diet, n=11) for 6 months. MAIN OUTCOME MEASURE Salivary cortisol measured at 8:00, 8:30, 11:00, 11:30, 12:30, 13:00, 16:00 and 16:30. Morning cortisol was defined as the mean cortisol concentration at 08:00 and 08:30. Diurnal cortisol was calculated as the mean of the 8 cortisol measures across the day. RESULTS In the whole cohort, higher morning and diurnal cortisol levels were associated with impaired insulin sensitivity (morning: P=0.004, r(2)=0.24; diurnal: P=0.02, r(2)=0.15). Using mixed model analysis, there was no significant effect of group, time or sex on morning or diurnal cortisol levels. CONCLUSION A 10% weight loss with a 25% CR diet alone or with exercise did not impact morning or diurnal salivary cortisol levels.
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Effect of fat loss on arterial elasticity in obese adolescents with clinical insulin resistance: RESIST study.
Ho, M, Gow, M, Baur, LA, Benitez-Aguirre, PZ, Tam, CS, Donaghue, KC, Craig, ME, Cowell, CT, Garnett, SP
The Journal of clinical endocrinology and metabolism. 2014;(10):E1846-53
Abstract
CONTEXT Reduced arterial elasticity contributes to an obesity-related increase in cardiovascular risk in adults. OBJECTIVE To evaluate the effect of fat loss on arterial elasticity in obese adolescents at risk of type 2 diabetes. DESIGN A secondary data analysis of the RESIST study was performed in two hospitals in Sydney, Australia. PARTICIPANTS The study included 56 subjects (ages, 10 to 17 y; 25 males) with prediabetes and/or clinical features of insulin resistance. INTERVENTION A 12-month lifestyle plus metformin intervention. OUTCOMES Arterial elasticity and systemic vascular resistance were measured using radial tonometry pulse contour analysis, percentage body fat (%BF) was measured by dual-energy x-ray absorptiometry, and insulin sensitivity index was derived from an oral glucose tolerance test and lipids. RESULTS Adolescents (n = 31) with decreased %BF (mean change [range], -4.4% [-18.3 to -0.01%]) after the intervention had significant increases in the mean large arterial elasticity index (mean change [95%CI], 5.1 [1.9 to 8.2] mL/mm Hg * 10; P = .003) and insulin sensitivity index (0.5 [0.1 to 0.9]; P = .010) and a decrease in systemic vascular resistance (-82 [-129 to -35] dyne * s * cm(-5); P = .001). There were no significant changes in these parameters in adolescents who increased their %BF. Nor was there any significant change in the mean small arterial elasticity index in either group. CONCLUSION Long-term follow-up of these adolescents is warranted to assess whether the observed changes in vascular elasticity will lead to a clinical benefit including reduced cardiovascular morbidity and mortality.
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Fasting plasma adropin concentrations correlate with fat consumption in human females.
St-Onge, MP, Shechter, A, Shlisky, J, Tam, CS, Gao, S, Ravussin, E, Butler, AA
Obesity (Silver Spring, Md.). 2014;(4):1056-63
Abstract
OBJECTIVE This study investigated whether plasma adropin concentrations are influenced by sleep restriction and correlate with dietary preferences. METHODS Plasma adropin concentrations were measured by ELISA using samples from a study that investigated feeding behavior in sleep deprived lean (body mass index 22-26 kg/m(2) ) men and women aged 30-45 y. Sleep (habitual or restricted to 4h/night) and diet were controlled during a 4-day inpatient period. On day 5, food was self-selected (FS). Adropin was measured on day 4 in samples collected throughout the day, and then after an overnight fast at 0730 on days 5 (Pre-FS) and 6 (Post-FS). RESULTS Plasma adropin concentrations were not affected by sleep restriction. However, circulating adropin concentrations correlated with food selection preferences in women, irrespective of sleep status. Pre-FS adropin correlated positively with fat intake (total fat, r = 0.867, P < 0.05; saturated fat, r = 0.959, P < 0.01) and negatively with carbohydrate intake (r = -0.894, P < 0.05) as a percent total energy. Post-FS adropin correlated with total (r = 0.797, P < 0.05) and saturated fat intake (r = 0.945, P < 0.01), and negative with total carbohydrate intake (r = -0.929, P < 0.01). Pre-FS adropin also correlated with fat intake in kcal adjusted for body size (total fat, r = 0.852, P < 0.05; saturated fat, r = 0.927, P < 0.01). CONCLUSIONS Plasma adropin concentrations correlate with fat consumption in women.