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A prospective randomized study comparing effects of empagliflozin to sitagliptin on cardiac fat accumulation, cardiac function, and cardiac metabolism in patients with early-stage type 2 diabetes: the ASSET study.
Hiruma, S, Shigiyama, F, Hisatake, S, Mizumura, S, Shiraga, N, Hori, M, Ikeda, T, Hirose, T, Kumashiro, N
Cardiovascular diabetology. 2021;(1):32
Abstract
BACKGROUND While the cardioprotective benefits of sodium-glucose cotransporter-2 (SGLT2) inhibitors have been established in patients with cardiovascular disease (CVD), their advantages over other anti-diabetic drugs at earlier stages remain unclear. We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on cardiac fat accumulation, cardiac function, and cardiac metabolism in patients with early-stage type 2 diabetes mellitus (T2DM) without CVD complications. METHODS This was a prospective, randomized, open-label, blinded-endpoint, parallel-group trial that enrolled 44 Japanese patients with T2DM. The patients were randomized for 12-week administration of empagliflozin or sitagliptin. Pericardial fat accumulation and myocardial triglyceride content were evaluated by magnetic resonance imaging and proton magnetic resonance spectroscopy, respectively. Echocardiography, 123I-β-methyl-iodophenyl pentadecanoic acid myocardial scintigraphy, and laboratory tests were performed at baseline and after the 12-week treatment period. RESULTS The patients were middle-aged (50.3 ± 10.7 years, mean ± standard deviation) and overweight (body mass index 29.3 ± 4.9 kg/m2). They had a short diabetes duration (3.5 ± 3.2 years), HbA1c levels of 7.1 ± 0.8%, and preserved cardiac function (ejection fraction 73.8 ± 5.0%) with no vascular complications, except for one baseline case each of diabetic nephropathy and peripheral arterial disease. After the 12-week treatment, no differences from baseline were observed between the two groups regarding changes in pericardial, epicardial, and paracardial fat content; myocardial triglyceride content; cardiac function and mass; and cardiac fatty acid metabolism. However, considering cardiometabolic biomarkers, high-density lipoprotein cholesterol and ketone bodies, including β-hydroxybutyric acid, were significantly increased, whereas uric acid, plasma glucose, plasma insulin, and homeostasis model assessment of insulin resistance were significantly lower in the empagliflozin group than in the sitagliptin group (p < 0.05). CONCLUSIONS Although the effects on cardiac fat and function were not statistically different between the two groups, empagliflozin exhibited superior effects on cardiometabolic biomarkers, such as uric acid, high-density lipoprotein cholesterol, ketone bodies, and insulin sensitivity. Therefore, when considering the primary preventive strategies for CVD, early supplementation with SGLT2 inhibitors may be more beneficial than DPP-4 inhibitors, even in patients with early-stage T2DM without current CVD complications. CLINICAL TRIAL REGISTRATION UMIN000026340; registered on February 28, 2017. https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030257.
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Weight Gain, Energy Intake, Energy Expenditure, and Immunosuppressive Therapy in Kidney Transplant Recipients.
Taşdemir, D, Aksoy, N
Progress in transplantation (Aliso Viejo, Calif.). 2020;(4):322-328
Abstract
BACKGROUND Weight gain after kidney transplantation is a common health problem. The factors in weight gain after kidney transplant include many factors such as age, ethnicity, gender, change in lifestyle (eg, kilocalorie intake and physical activity level), and immunosuppressive therapy. RESEARCH QUESTIONS This study aimed to evaluate the relationship between weight gain and energy intake in dietary, energy expenditure in physical activity, and immunosuppressive therapy in kidney transplant recipients. DESIGN This prospective, observational study included 51 participants who underwent kidney transplant, during 6 months from the start of the study. Anthropometric measurements were performed at first week, third- and sixth-month follow-ups of transplant recipients. Participants also completed 3-day "Dietary Record Form" and the "Physical Activity Record Form" at each follow-up. Simple frequency, analysis of variance analysis, and correlation analysis were used for data analysis. RESULTS Weight gain in sixth month follow-up compared to baseline value was positively related to energy intake in first week (r = 0.59), third month (r = 0.75), and sixth month (r = 0.67) follow-ups, and energy expenditure in first week (r = 0.35) and sixth month (r = 0.34) follow-ups. However, weight gain was negatively related to mycophenolate mofetil dose (mg/d) in sixth month (r = -0.31) follow-up (P < .05). DISCUSSION The results of this study provide an opportunity to reflect and discuss on modifiable risk factors such as energy intake and energy expenditure that affect weight gain posttransplantation in participants. It also examines the relationship between immunosuppressive therapy. Additionally, these results can be effective in designing interventions and managing risk factors to achieve weight management goals.
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Comparison of estimated energy requirements using predictive equations with total energy expenditure measured by the doubly labelled water method in acute spinal cord injury.
Desneves, KJ, Panisset, MG, Rafferty, J, Rodi, H, Ward, LC, Nunn, A, Galea, MP
Spinal cord. 2019;(7):562-570
Abstract
STUDY DESIGN Prospective, observational OBJECTIVES To evaluate agreement between a reference method (doubly labelled water, DLW) of total energy expenditure (TEE) and published equations for estimating energy requirements in acute spinal cord injury (SCI). SETTING Victoria, Australia METHODS Twenty participants (18 male) within 8 weeks of traumatic SCI completed DLW, anthropometric and dietary intake assessments. Energy requirements were predicted using Harris-Benedict, Schofield, Henry, Nelson, Buchholz and Chun equations, multiplied by a combined activity and stress factor of 1.3, and the ratio method (kJ/kg body weight). Fat-free mass (FFM) and fat mass (FM) were calculated from TBW-derived DLW and from bioelectrical impedance spectroscopy (BIS). RESULTS Median time since injury was 41 days. Median TEE was 9.1 MJ. Fair agreement was found between TEE and predicted energy requirements for the Chun (rc = 0.39), the Harris-Benedict equation (rc = 0.30), the ratio method (rc = 0.23) and the Buchholz (rc = 0.31) and Nelson equations (rc = 0.35), which incorporate measures of FFM and/or FM. Other equations showed weak concordance with DLW. When two hypermetabolic patients were removed, agreement between TEE and predicted energy requirements using the Buchholz equation increased to substantial (rc = 0.72) and using the Nelson (rc = 0.53) and Chun equations (rc = 0.53) increased to moderate. The Buchholz equation had the smallest limits of agreement (-2.4-2.3 MJ/d). CONCLUSION The population-specific Buchholz equation that incorporates FFM, predicted from either BIS or DLW, demonstrated the best agreement in patients with acute SCI. SPONSORSHIP The study was funded by grants from the Institute for Safety, Compensation and Recovery Research (ISCRR Project # NGE-E-13-078) and Austin Medical Research Foundation. M Panisset was supported by an Australian Postgraduate Award.
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Differences in energy expenditure in human donor milk versus formula milk in preterm newborns: A crossover study.
Soares, FVM, Abranches, AD, Méio, MDBB, Gomes, SC, Villela, LD, Moreira, MEL
Nutrition (Burbank, Los Angeles County, Calif.). 2019;:1-4
Abstract
OBJECTIVE The aim of this study was to compare the ratio between energy expenditure and caloric density in human donor milk versus formula milk in preterm newborn infants. METHODS This was a crossover, randomized clinical trial with 29 preterm newborn infants receiving full diet. The infants were randomly assigned to receive either human milk or formula milk alternating, after a 24-h period. Energy expenditure was evaluated by indirect calorimetry. Total calorie and macronutrient values in the human milk were calculated individually with infrared technique; energy expenditure/caloric density ratio was calculated. RESULTS Human donor milk energy expenditure/caloric density ratio was significantly greater than in formula milk at all time points. The total mean was 1.04 ± 0.27 for the human milk and 0.81 ± 0.11 for the formula. However, when we analyzed a subgroup of newborns that received human donor milk with >60 kcal/100 mL, there was no statistical difference (P = 0.36). The mean calorie values were 58.9 kcal/100 mL (human donor milk) and 81.4 kcal/100 mL (formula milk). CONCLUSION Formula milk produced a better metabolic response than human donor milk. Human donor milk with higher caloric content showed no difference from formula, so the use of human donor milk with more caloric density should be reinforced.
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Energy Expenditure, Carbohydrate Oxidation and Appetitive Responses to Sucrose or Sucralose in Humans: A Pilot Study.
Chern, C, Tan, SY
Nutrients. 2019;(8)
Abstract
BACKGROUND In light of obesity, replacing sugar with non-nutritive sweeteners is commonly used to reduce sugar content of food products. This study aimed to compare human energy expenditure (EE), carbohydrate oxidation and food intake after the ingestion of test foods sweetened with sucrose or a non-nutritive sweetener. METHODS This was an acute crossover feeding study that entailed consumption of three test foods: jelly sweetened with 50 g sucrose (SUCROSE), with 120 mg of sucralose only (NNS), or 120 mg sucralose but matched in carbohydrate with 50 g maltodextrin (MALT). On test days, participants arrived at the research facility after an overnight fast. Resting energy expenditure (indirect calorimeter) was measured for 30 min followed by jelly consumption. Participants' EE and substrate oxidation were measured for 90 min subsequently. After EE assessment, participants completed a meal challenge before leaving the research facility, and recorded food intake for the remaining day. Subjective appetite ratings were assessed before and after test foods and meal challenge. RESULTS Eleven participants completed the study. EE was higher in SUCROSE and MALT than NNS, but not statistically significant. Carbohydrate oxidation was SUCROSE > MALT > NNS (p < 0.001). Earlier and bigger rise in carbohydrate oxidation was observed in SUCROSE than MALT, although both were carbohydrate-matched. NNS did not promote energy expenditure, carbohydrate oxidation or stimulate appetite. CONCLUSIONS Foods sweetened with sucrose or non-nutritive sweeteners but matched in carbohydrate content have different effects on human EE and carbohydrate oxidation. Sucralose alone did not affect EE, but lower energy in the test food from sugar replacement was eventually fully compensated. Findings from this pilot study should be verified with bigger clinical studies in the future to establish clinical relevance.
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Effect of switching from pioglitazone to the sodium glucose co-transporter-2 inhibitor dapagliflozin on body weight and metabolism-related factors in patients with type 2 diabetes mellitus: An open-label, prospective, randomized, parallel-group comparison trial.
Cho, KY, Nakamura, A, Omori, K, Takase, T, Miya, A, Manda, N, Kurihara, Y, Aoki, S, Atsumi, T, Miyoshi, H
Diabetes, obesity & metabolism. 2019;(3):710-714
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The effects of dapagliflozin (DAP) and pioglitazone (PIO) on body weight and glycaemic control were compared in patients with type 2 diabetes mellitus. Seventy-one patients on PIO were either switched to DAP (n = 36) at 5 mg per day or continued on PIO (n = 35). Primary endpoints were superiority of body weight loss and non-inferiority of HbA1c level after 24 weeks with DAP. Body weight decrease was greater with DAP than with PIO (75.3 ± 14.9 to 71.3 ± 15.1 kg vs. 74.7 ± 13.8 to 75.2 ± 13.9 kg; P < 0.01). Change in the HbA1c level was comparable (P = 0.64). The level of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and urinary albumin : creatinine ratio (ACR) decreased only with DAP (NT-proBNP, P < 0.01; ACR, P = 0.02), and the change in NT-proBNP correlated negatively with baseline NT-proBNP level (ρ = -0.68, P < 0.01) and log-converted ACR (ρ = -0.35, P < 0.05). DAP promotes body weight loss in type 2 diabetes mellitus and may decrease fluid retention, thus reducing the occurrence of cardiovascular events.
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Impact of l-citrulline supplementation on oxygen uptake kinetics during walking.
Ashley, J, Kim, Y, Gonzales, JU
Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme. 2018;(6):631-637
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Supplementation with l-citrulline (Cit) has been shown to improve muscle oxygenation and oxygen uptake kinetics during moderate- to high-intensity cycling in young men. The aim of this study was to test the hypothesis that Cit would improve oxygen uptake kinetics during walking in older and young adults. In a randomized, double-blind study, 26 (15 women, 11 men) adults between the ages of 20-35 years (n = 15) and 64-86 years (n = 11) completed 7-day periods of taking placebo and Cit (6 g/day) in a crossover manner. Participants walked on a treadmill at 40% heart rate reserve while pulmonary oxygen uptake was measured using indirect calorimetry. Net oxygen cost, mean response time (MRT), and the oxygen deficit were calculated before and after each supplement period. There was no significant change (P > 0.05) in net oxygen cost, MRT, or the oxygen deficit after Cit in older adults, while young adults showed a decrease (P = 0.05) in the oxygen deficit after Cit that tended (P = 0.053) to be different than the change after placebo. Sex-stratified analysis revealed that Cit decreased MRT (P = 0.04, Cohen's d = 0.41) and the oxygen deficit (P < 0.01, Cohen's d = 0.56) in men with the change after Cit being greater than the change after placebo (MRT: -4.5 ± 2.1 vs. 3.4 ± 2.1 s, P = 0.01; deficit: -0.15 ± 0.05 vs. 0.01 ± 0.05 L, P = 0.02). All oxygen uptake parameters were unchanged (P > 0.05) following Cit and placebo in women. Cit does not alter the oxygen cost of moderate-intensity walking in young or older adults, but Cit improved the rate of rise in oxygen uptake at exercise onset in men.
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Diurnal distribution of carbohydrates and fat affects substrate oxidation and adipokine secretion in humans.
Kessler, K, Hornemann, S, Petzke, KJ, Kemper, M, Markova, M, Rudovich, N, Grune, T, Kramer, A, Pfeiffer, AFH, Pivovarova-Ramich, O
The American journal of clinical nutrition. 2018;(6):1209-1219
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BACKGROUND A diet in which fat is mainly eaten in the morning and carbohydrates mainly in the evening (compared with the reverse order) was recently shown to worsen glycemic control in people with prediabetes. OBJECTIVE We investigated the effects of these dietary patterns on energy metabolism, and on the daily profiles of circulating lipids, adipokines, and inflammatory markers. DESIGN In a randomized controlled crossover trial, 29 nonobese men (with normal glucose tolerance, n = 18; or impaired fasting glucose/glucose tolerance, n = 11) underwent 2 isocaloric 4-wk diets: 1) carbohydrate-rich meals until 1330 and fat-rich meals between 1630 and 2200 (HC/HF); or 2) the inverse sequence of meals (HF/HC). During a 12-h clinical investigation day after each intervention period, 2 meal tolerance tests were performed, at 0900 and 1540, respectively. Substrate oxidation and concentrations of circulating lipids, adipokines, and cytokines were assessed pre- and postprandially. The postprandial inflammatory response in leukocytes was analyzed ex vivo. RESULTS Fasting carbohydrate oxidation decreased (P = 0.004) and lipid oxidation increased (P = 0.012) after the HC/HF diet. Fasting concentrations of blood markers did not differ between diets. The diets modulated the daily profiles of carbohydrate oxidation, lipid oxidation, and β-hydroxybutyrate, although the average daily values of these parameters showed no difference between the diets, and no interaction between diet and glucose tolerance status. Diurnal patterns of triglycerides, low-density lipoprotein cholesterol, leptin, visfatin, and of LPS-induced cytokine secretion in blood leukocytes were also modulated by the diets. Average daily concentrations of leptin (P = 0.017) and visfatin (P = 0.041) were lower on the HF/HC diet than on the HC/HF diet. CONCLUSIONS Diurnal distribution of carbohydrates and fat affects the daily profiles of substrate oxidation, circulating lipids, and cytokine secretion, and alters the average daily concentrations of adipokine secretion in nonobese nondiabetic humans. The study was registered at clinicaltrials.gov as NCT02487576.
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Acute effects of reducing sitting time in adolescents: a randomized cross-over study.
Penning, A, Okely, AD, Trost, SG, Salmon, J, Cliff, DP, Batterham, M, Howard, S, Parrish, AM
BMC public health. 2017;(1):657
Abstract
BACKGROUND Levels of sitting among adolescents are high, especially during the school day. The acute cognitive and health consequences associated with prolonged sitting are poorly understood in adolescents. This randomized crossover design study examined the acute effects of a simulated school day with reduced sitting or usual sitting on adolescents' cognitive function and cardiometabolic biomarkers. METHODS Eighteen healthy school aged adolescents were recruited from the community to the study (11 males; 7 females; mean age [SD] = 13.5 ± 0.9 years). Two protocols were developed to simulate an adolescent school day, the amount of time spent sitting was manipulated reflecting: a 'typical' day (65% of the time spent sitting with two sitting bouts sitting >20 min) and a 'reduced sitting' day (adolescents sat for 50% less time with no bouts of sitting >20 mins). The order that participants were exposed to each condition was randomized (via random number generator). Participants were not fully blinded as they could observe the difference between conditions. Energy intake and moderate to vigorous physical activity (MVPA) were standardized for both conditions and monitored for 48 h post-condition for compensatory effects. Cognitive (working memory) and cardiometabolic outcomes (lipids, glucose, insulin, IL-6, apo-A1, apo-B, blood pressure,) were assessed pre and post for both conditions, BMI and body fat were assessed on the morning of the intervention. Data were analyzed using linear mixed models. Standardised effect sizes were calculated. RESULTS Compared with the typical school day, the reduced sitting day demonstrated significant positive effects for apoB/apoA-1 ratio (adjusted difference ± SD) -0.02 ± 0.03; P = 0.03; effect size [Cohen's d] = -0.67. Findings for total cholesterol -0.19 ± 0.27; P = 0.28; d = -0.71; HDL cholesterol -0.23 ± 0.50; P = 0.12 d = -0.66; and total cholesterol/HDL ratio 0.25 ± 0.53; P = 0.25; d = 0.51 and for cognition 0.64 ± 0.15; P = 0.15; d = 0.54 were non-significant. There were no compensatory changes in participant energy expenditure or energy intake for 48 h post intervention. CONCLUSION Reducing school day sitting time in adolescents' resulted in significant improvements in apoB/apoA-1 ratio with medium effect sizes for total cholesterol, HDL cholesterol and total cholesterol/HDL ratio. Cognitive function results showed the equivalent of a 6 month improvement in effective mental-attentional capacity. TRIAL REGISTRATION The trial was registered as a clinical trial with the Australian and New Zealand Clinical Trials Registry ( ACTRN12614001064695 ) on the 3rd of October 2014 - registered retrospectively.
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Is the timing of caloric intake associated with variation in diet-induced thermogenesis and in the metabolic pattern? A randomized cross-over study.
Bo, S, Fadda, M, Castiglione, A, Ciccone, G, De Francesco, A, Fedele, D, Guggino, A, Parasiliti Caprino, M, Ferrara, S, Vezio Boggio, M, et al
International journal of obesity (2005). 2015;(12):1689-95
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BACKGROUND/OBJECTIVES Food-induced thermogenesis is generally reported to be higher in the morning, although contrasting results exist because of differences in experimental settings related to the preceding fasting, exercise, sleeping and dieting. To definitively answer to this issue, we compared the calorimetric and metabolic responses to identical meals consumed at 0800 hours and at 2000 hours by healthy volunteers, after standardized diet, physical activity, duration of fast and resting. SUBJECTS/METHODS Twenty subjects (age range 20-35 years, body mass index=19-26 kg m(-)(2)) were enrolled to a randomized cross-over trial. They randomly received the same standard meal in the morning and, 7 days after, in the evening, or vice versa. A 30-min basal calorimetry was performed; a further 60-min calorimetry was done 120-min after the beginning of the meal. Blood samples were drawn every 30-min for 180-min. General linear models, adjusted for period and carry-over, were used to evaluate the 'morning effect', that is, the difference of morning delta (after-meal minus fasting values) minus evening delta (after-meal minus fasting values) of the variables. RESULTS Fasting resting metabolic rate (RMR) did not change from morning to evening; after-meal RMR values were significantly higher after the morning meal (1916; 95% confidence interval (CI)=1792, 2041 vs 1756; 1648, 1863 kcal; P<0.001). RMR was significantly increased after the morning meal (90.5; 95% CI=40.4, 140.6 kcal; P<0.001), whereas differences in areas-under-the-curve for glucose (-1800; -2564,-1036 mg dl(-1) × h, P<0.001), log-insulin (-0.19; -0.30,-0.07 μU ml(-1) × h; P=0.001) and fatty free acid concentrations (-16.1;-30.0,-2.09 mmol l(-1) × h; P=0.024) were significantly lower. Delayed and larger increases in glucose and insulin concentrations were found after the evening meals. CONCLUSIONS The same meal consumed in the evening determined a lower RMR, and increased glycemic/insulinemic responses, suggesting circadian variations in the energy expenditure and metabolic pattern of healthy individuals. The timing of meals should probably be considered when nutritional recommendations are given.