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Functional recovery in human partial thickness skin wounds after application of multicomponent hydrolipidic film (MAS063DP): A prospective, open-label, comparative clinical trial.
Lin, ET, Lin, BS, Tsai, LC, Chen, WK, Wang, YJ, Chiang, HM, Chang, CC
Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society. 2021;(1):87-96
Abstract
Acute and minor skin wounds are common in daily life. However, in clinical practice, after initial management in the acute phase, the wounds are managed mainly through observation, and the patients are usually lost to follow-up. Considering a multicomponent hydrolipidic dressing (MAS063DP) long-known for its safe application in eczema and recently in laser-induced wounds, we aimed to evaluate its ability in functional recovery of impaired skin integrity during wound healing. Sixteen patients (N = 16) were enrolled and completed (n = 8 vs n = 8) this prospective, open-label, vehicle-controlled clinical trial with 12-week follow-up. Transepidermal water, skin viscoelasticity and bioimpedance analysis were measured initially, at the 1st, 4th, 8th, and 12th weeks. Improvements in these parameters were greater in the MAS063DP group (from 31.4 ± 9.0 to 16.4 ± 4.3 g/m2 h, P < .001; from 77 ± 16% to 88 ± 9%, P < .05; from 4182 ± 3823 to 2644 ± 1772 Ω) than in the white petrolatum group. No significant adverse events occurred, and all participants were more satisfied with the intervention. In this study, MAS063DP can restore skin integrity and reinstitute physiologic function as a feasible and safe intervention more markedly than management through observation during the healing process by providing protective hydrolipidic layer on the skin with simultaneous anti-inflammatory and antioxidant activities from its key ingredients such as glycyrrhetinic acid, Vitis vinifera, telmesteine, and vitamins C and E.
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The Positive Impact of Resistance Training on Muscle Mass and Serum Leptin Levels in Patients 2-7 Years Post-Roux-en-Y Gastric Bypass: A Controlled Clinical Trial.
Rios, INMS, Lamarca, F, Vieira, FT, de Melo, HAB, Magalhães, KG, de Carvalho, KMB, Pizato, N
Obesity surgery. 2021;(8):3758-3767
Abstract
PURPOSE Resistance training program (RTP) assist the maintenance of optimal body composition and inflammatory response modulation in individuals in late Roux-en-Y gastric bypass (RYGB). This study aimed to investigate the effect of RTP on body composition and serum inflammatory profile in individuals 2-7 years post-RYGB. METHODS Volunteers were matched on body mass index (BMI), age, sex, and years after surgery, and they were allocated as control or RTP group. Body composition, visceral fat area (VFA), and inflammatory serum markers were measured at baseline and after 12 weeks of RTP. RESULTS The sample baseline characteristics (n = 63; BMI = 29.7 ± 5.3 kg/m2) were similar between the groups. After intervention, the RTP group presented higher fat-free mass (Δ 1.17 ± 1.12 kg, p = 0.003) and skeletal muscle mass (Δ 0.77 ± 0.66 kg, p = 0.002) and decreased leptin levels (Δ -0.15 ± 0.60 pg/mL, p = 0.028). Ultrasensitive C-reactive protein (CRPus), interleukin-6, adiponectin, and monocyte chemotactic protein-1 showed no significant time-by-group interaction. After the categorization of RTP group individuals by VFA median values (129.8 cm2, IQR 90.9; 152.5), participants with VFA values above the median presented a significant decrease in CRPus (Δ -0.20 mg/L, IQR -7.59; -0.03, p = 0.022) when compared to the participants with VFA values below the median. CONCLUSION The RTP improved individuals' body composition by a modest but significant enhancing muscle mass and decreasing serum leptin and CRPus levels, especially in individuals with VFA values above the median. RTPs assist in maintaining the adequate body composition as they contribute to a decrease in proinflammatory markers in long-term RYGB.
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Effects of time-restricted feeding in weight loss, metabolic syndrome and cardiovascular risk in obese women.
Schroder, JD, Falqueto, H, Mânica, A, Zanini, D, de Oliveira, T, de Sá, CA, Cardoso, AM, Manfredi, LH
Journal of translational medicine. 2021;(1):3
Abstract
BACKGROUND The increasing prevalence of overweight and obesity among the worldwide population has been associated with a range of adverse health consequences such as Type 2 diabetes and cardiovascular diseases. The metabolic syndrome (MetS) is a cluster of cardiometabolic abnormalities that occur more commonly in overweight individuals. Time-restricted feeding (TRF) is a dietary approach used for weight loss and overall health. TRF may be an option for those subjects who struggle with extreme restriction diets with foods that generally do not belong to an individual's habits. OBJECTIVE The purpose of this study was to determine the effect of TRF on body composition and the association of weight loss with metabolic and cardiovascular risks in obese middle-aged women. METHODS A non-randomized controlled clinical trial was performed over 3 months in obese women (TRF group, n = 20, BMI 32.53 ± 1.13 vs. Control n = 12, BMI 34.55 ± 1.20). The TRF protocol adopted was 16 h without any energy intake followed by 8 h of normal food intake. MAIN OUTCOMES AND MEASURES Anthropometric measurements, body composition, blood biomarkers, cardiovascular risk in 30 years (CVDRisk30y), and quality of life were evaluated at baseline and after the 3 months. RESULTS TRF was effective in reducing weight (~ 4 kg), BMI, % of body fat (%BF), waist circumference from baseline without changes in blood biomarkers associated with MetS. TRF promoted a reduction in CVDRisk30y (12%) wich was moderately correlated with %BF (r = 0.62, n = 64, p < 0.001) and %MM (r = - 0.74, n = 64, p < 0.001). CONCLUSIONS TRF protocol reduces body weight without changes in biomarkers related to MetS. In addition, the anthropometric evaluation that predicts %BF and %MM could be used as an approach to follow individuals engaged in the TRF regimen since they correlate with cardiovascular risk.
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Increased postprandial nonesterified fatty acid efflux from adipose tissue in prediabetes is offset by enhanced dietary fatty acid adipose trapping.
Montastier, É, Ye, RZ, Noll, C, Bouffard, L, Fortin, M, Frisch, F, Phoenix, S, Guérin, B, Turcotte, ÉE, Lewis, GF, et al
American journal of physiology. Endocrinology and metabolism. 2021;(6):E1093-E1106
Abstract
The mechanism of increased postprandial nonesterified fatty acid (NEFA) appearance in the circulation in impaired glucose tolerance (IGT) is due to increased adipose tissue lipolysis but could also be contributed to by reduced adipose tissue (AT) dietary fatty acid (DFA) trapping and increased "spillover" into the circulation. Thirty-one subjects with IGT (14 women, 17 men) and 29 with normal glucose tolerance (NGT, 15 women, 14 men) underwent a meal test with oral and intravenous palmitate tracers and the oral [18F]-fluoro-thia-heptadecanoic acid positron emission tomography method. Postprandial palmitate appearance (Rapalmitate) was higher in IGT versus NGT (P < 0.001), driven exclusively by Rapalmitate from obesity-associated increase in intracellular lipolysis (P = 0.01), as Rapalmitate from DFA spillover was not different between the groups (P = 0.19) and visceral AT DFA trapping was even higher in IGT versus NGT (P = 0.02). Plasma glycerol appearance was lower in IGT (P = 0.01), driven down by insulin resistance and increased insulin secretion. Thus, we found higher AT DFA trapping, limiting spillover to lean organs and in part offsetting the increase in Rapalmitate from intracellular lipolysis. Whether similar findings occur in frank diabetes, a condition also characterized by insulin resistance but relative insulin deficiency, requires further investigation (Clinicaltrials.gov: NCT04088344, NCT02808182).NEW & NOTEWORTHY We found higher adipose tissue dietary fatty acid trapping, limiting spillover to lean organs, that in part offsets the increase in appearance rate of palmitate from intracellular lipolysis in prediabetes. These results point to the adaptive nature of adipose tissue trapping and dietary fatty acid spillover as a protective mechanism against excess obesity-related palmitate appearance rate from intracellular adipose tissue lipolysis.
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Natriuretic Effect of Two Weeks of Dapagliflozin Treatment in Patients With Type 2 Diabetes and Preserved Kidney Function During Standardized Sodium Intake: Results of the DAPASALT Trial.
Scholtes, RA, Muskiet, MHA, van Baar, MJB, Hesp, AC, Greasley, PJ, Karlsson, C, Hammarstedt, A, Arya, N, van Raalte, DH, Heerspink, HJL
Diabetes care. 2021;(2):440-447
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Abstract
OBJECTIVE Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk for heart failure hospitalization potentially by inducing sodium excretion, osmotic diuresis, and plasma volume contraction. Few studies have investigated this hypothesis, but none have assessed cumulative sodium excretion with SGLT2 inhibition during standardized sodium intake in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS The DAPASALT trial was a mechanistic, nonrandomized, open-label study in patients with type 2 diabetes with preserved kidney function on a controlled standardized sodium diet (150 mmol/day). It evaluated the effects of dapagliflozin on sodium excretion, 24-h blood pressure, and extracellular, intracellular, and plasma volumes at the start of treatment (ST) (days 2-4), end of treatment (ET) (days 12-14), and follow-up (FU) (days 15-18). RESULTS Fourteen patients were included in the efficacy analysis. Mean (SD) baseline sodium excretion (150 [32] mmol/24-h) did not significantly change during treatment (change at ST: -7.0 mmol/24-h [95% CI -22.4, 8.4]; change at ET: 2.1 mmol/24-h [-28.8, 33.0]). Mean baseline 24-h systolic blood pressure was 128 (10) mmHg and significantly reduced at ST (-6.1 mmHg [-9.1, -3.1]; P < 0.001) and ET (-7.2 mmHg [-10.0, -4.3]; P < 0.001). Dapagliflozin did not significantly alter plasma volume or intracellular volume, while extracellular volume changed at ST (-0.7 L [-1.3, -0.1]; P = 0.02). As expected, 24-h urinary glucose excretion significantly increased during dapagliflozin treatment and reversed during FU. CONCLUSIONS During standardized sodium intake, dapagliflozin reduced blood pressure without clear changes in urinary sodium excretion, suggesting that factors other than natriuresis and volume changes may contribute to the blood pressure-lowering effects.
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Seven-day fasting as a multimodal complex intervention for adults with type 1 diabetes: Feasibility, benefit and safety in a controlled pilot study.
Berger, B, Jenetzky, E, Köblös, D, Stange, R, Baumann, A, Simstich, J, Michalsen, A, Schmelzer, KM, Martin, DD
Nutrition (Burbank, Los Angeles County, Calif.). 2021;:111169
Abstract
OBJECTIVES Intermittent as well as prolonged fasting are receiving considerable attention and appear favorable in conditions such as metabolic syndrome, type 2 diabetes, and rheumatic diseases. Fasting for individuals with type 1 diabetes (T1D) is generally considered too risky. However, the ability and possibility to change from carbohydrate- to ketone-based fuel supply might be relevant for individuals with T1D. The aim of this patient-led research was to investigate the feasibility, benefit, and safety of a 7-d multimodal fasting intervention in individuals with T1D. METHODS This was a non-randomized controlled pilot study, with 20 participants with T1D and 10 without the disease. Data acquisition took place before, after, and 4 mo after the intervention and daily during intervention. RESULTS Of the individuals with T1D, 19 finished fasting. A mean β-hydroxybutyrate as representative ketone body increased to 2.8 ± 1.9 mmol/L on day 7; whereas average glucose remained between 4.9 (±1.5) and 7.5 (±2.3) mmol/L (89 ± 27 and 136 ± 40 mg/dL). Mean daily insulin dose was adjusted from 24.4 (3-50) IU on the day before fasting to 7.6 (0-26.7) IU on day 7. Quality of life (WHO-5) normalized from 54 (±4.4) to 68.8 (±15; P = 0.01) after fasting. There was a decrease from before until the follow-up 4 mo later of weight from 77.6 (±20.4) to 76.6 (±20.9) kg (P = 0.023) and for body mass index from 27.68 (±7.04) to 26.74 (±7.15) kg/m2 (P = 0.008). Diastolic blood pressure increased from 69.75 (±11.41) to 75.74 (±8.42) mm Hg (P = 0.028) and stayed in a healthy range on average. Fasting-related side effects were all temporary, and slightly more prevalent in those with type 1 diabetes compared with the reference group. CONCLUSIONS This study demonstrated the feasibility, benefits, and safety aspects of a 7-d fast in adults with T1D.
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Acute effects of MDMA on trust, cooperative behaviour and empathy: A double-blind, placebo-controlled experiment.
Borissova, A, Ferguson, B, Wall, MB, Morgan, CJ, Carhart-Harris, RL, Bolstridge, M, Bloomfield, MA, Williams, TM, Feilding, A, Murphy, K, et al
Journal of psychopharmacology (Oxford, England). 2021;(5):547-555
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Abstract
BACKGROUND 3,4-Methylenedioxymethamphetamine (MDMA) is being actively researched as an adjunct to psychotherapy. It may be beneficial to trust, empathy and cooperative behaviour due to its acute prosocial effects. AIM: To test (a) the acute effects of MDMA on measures of empathy, trust and cooperative behaviour, and (b) subacute changes in mood three days after MDMA administration. METHODS Twenty-five participants (n=7 female), participated in this double-blind, repeated-measures, placebo-controlled experiment. Participants attended two acute sessions, one week apart. Each acute session was followed by a subacute session three days later. Participants received placebo (100 mg ascorbic acid) during one acute session, and MDMA (100 mg MDMA-HCl) at the other, with order counterbalanced. Participants completed the following tasks assessing prosocial behaviour: a trust investment task, a trustworthy face rating task, an empathic stories task, a public project game, a dictator game and an ultimatum game. Participants reported subjective effects. Blood was taken pre-drug, 2 and 4 hours post-drug, and tested for plasma MDMA levels. RESULTS MDMA acutely increased self-reported 'closeness to others' and 'euphoria' and increased plasma concentrations of MDMA. MDMA did not significantly change task-based empathy, trust or cooperative behaviour. Using Bayesian analyses, we found evidence that MDMA and placebo did not differ in their effects on empathy and cooperative behaviour. MDMA did not significantly change subacute mood and this was supported by our Bayesian analyses. CONCLUSION Despite augmentation in plasma MDMA levels and subjective drug effects, we found no increase in prosocial behaviour in a laboratory setting.
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Effect of oral semaglutide on the pharmacokinetics of thyroxine after dosing of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of oral semaglutide in healthy subjects: an open-label, one-sequence crossover, single-center, multiple-dose, two-part trial.
Hauge, C, Breitschaft, A, Hartoft-Nielsen, ML, Jensen, S, Bækdal, TA
Expert opinion on drug metabolism & toxicology. 2021;(9):1139-1148
Abstract
BACKGROUND Oral semaglutide comprises the glucagon-like peptide-1 analog, semaglutide, and sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). Levothyroxine has similar dosing conditions to oral semaglutide. This trial investigated if oral semaglutide co-administered with levothyroxine affects thyroxine (T4) exposure and if multiple placebo tablets co-administered with oral semaglutide affect semaglutide exposure. RESEARCH DESIGN AND METHODS In this one-sequence crossover trial, 45 healthy subjects received levothyroxine (600 μg single-dose) alone, or with concomitant SNAC 300 mg or concomitant oral semaglutide 14 mg at steady-state. Subjects also received oral semaglutide 14 mg at steady-state alone or with five placebo tablets once-daily for 5 weeks. RESULTS A 33% increase in total T4 exposure was observed with levothyroxine/oral semaglutide vs levothyroxine alone, but baseline-corrected maximum concentration (Cmax) was unaffected. SNAC alone did not affect total T4 exposure, whereas Cmax was slightly decreased. A 34% decrease in semaglutide exposure was observed when oral semaglutide was co-administered with placebo tablets, and Cmax also decreased. CONCLUSIONS Levothyroxine pharmacokinetics were influenced by co-administration with oral semaglutide. Monitoring of thyroid parameters should be considered when treating patients with both oral semaglutide and levothyroxine. Oral semaglutide exposure was influenced by co-administration with multiple tablets, which is addressed in the dosing guidance.
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Miconia albicans and Curcuma longa herbal medicines positively modulate joint pain, function and inflammation in patients with osteoarthritis: a clinical study.
Gomes, TPO, Souza, JIN, Somerlate, LC, Mendonça, VA, Lima, NM, Carli, GP, Castro, SBR, de Jesus A S Andrade, T, Dias, JVL, Oliveira, MAL, et al
Inflammopharmacology. 2021;(2):377-391
Abstract
This study aims to evaluate the analgesic and modulating effect of Curcuma longa and Miconia albicans herbal medicines in knee's osteoarthritis (OA) treatment. This longitudinal study evaluated 24 patients with OA. The patients were divided into three groups: ibuprofen (1200 mg/day), C. longa (1000 mg/day) and M. albicans (1000 mg/day). The medications were applied orally for 30 days. The synovial fluid of the knee joint was collect at the first (day 0) and the last medical (day 30) consultation. The groups treated with herbal medicines presented the same results when compared to Ibuprofen. The comparison of the means of Total WOMAC for M. albicans before and after treatment presented a statistically significant difference (mean day 0 = 57.19; mean day 30 = 31.02) as well as variation of Total WOMAC for C. longa (mean day 0 = 54.79; mean day 30 = 37.08). The WOMAC Total and the VASP were compared, it was found that there was a significant decrease in the means in the C. longa and M. albicans groups, as well as in the Ibuprofen group after treatment. The study demonstrated that the treatment of knee OA with C. longa or M. albicans positively interferes with patients pain and functionality, decreased WOMAC and VASP scores, leading to functional improvement of these patients. This is the first clinical study demonstrating the analgesic and anti-inflammatory effect on knee osteoarthritis from M. albicans comparable to Ibuprofen drug.
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Primary Care and Physical Literacy: A Non-Randomized Controlled Pilot Study to Combat the High Prevalence of Physically Inactive Adults in Austria.
Holler, P, Jaunig, J, Moser, O, Tuttner, S, Simi, H, Wallner, D, Amort, FM, van Poppel, M
International journal of environmental research and public health. 2021;(16)
Abstract
The multidimensional concept of physical literacy is fundamental for lifelong physical activity engagement. However, physical literacy-based interventions are in their infancy, especially among adults. Therefore, the purpose of this pilot study was to assess the association of a physical literacy-based intervention with changes in self-reported physical literacy among inactive adults. A non-randomized controlled study (2 × 2 design) was conducted, comparing pre- vs. postintervention. Twenty-eight inactive healthy participants in the intervention group (89% female, 53 ± 10 years) entered a physical literacy-based intervention once weekly for 14 weeks. The non-treated control group consisted of 22 inactive adults (96% female, 50 ± 11 years). Physical literacy was evaluated with a questionnaire encompassing five domains: physical activity behavior, attitude/understanding, motivation, knowledge, and self-efficacy/confidence. ANOVA models were applied to evaluate changes by time and condition. Following the intervention, significant improvements were seen for overall physical literacy and in four out of five physical literacy domains, including physical activity behavior, attitude/understanding, knowledge, and self-efficacy/confidence (all p < 0.01, Cohen's d = 0.38-0.83). No changes by time x condition were found for motivation. The physical literacy-based intervention applied in this study may be a promising approach to help inactive adults to adopt an active lifestyle.