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Conclusion | gallstone | GALLSTONE | UDCA treatment leads to a higher, but clinically irrelevant increase in ALP level in patients 6 months after bariatric surgery. No other changes in metabolic or inflammatory markers were observed. Except for the reduction of gallstone formation, UDCA has no effects after bariatric surgery. | PMC10234851 |
Graphical Abstract | PMC10234851 | |||
Supplementary Information | The online version contains supplementary material available at 10.1007/s11695-023-06581-8. | PMC10234851 | ||
Keywords | PMC10234851 | |||
Introduction
| non-alcoholic fatty liver disease, gallstones, Gallstone disease, nausea, NAFLD, diarrhea, skin rash, PBC, gallstone disease | GALLSTONES, PBC, MORBID OBESITY, INFLAMMATION, COMPLICATION, NON-ALCOHOLIC FATTY LIVER DISEASE, GALLSTONE DISEASE, PRIMARY BILIARY CIRRHOSIS | Gallstone disease is a common complication after bariatric surgery, the most effective long-term treatment for morbid obesity. Recently, the UPGRADE trial demonstrated that in patients without gallstones before bariatric surgery the prophylactic use of ursodeoxycholic acid (UDCA) for 6 months after surgery reduces the ... | PMC10234851 |
Methods | PMC10234851 | |||
Study Design and Population | gallstone disease | GALLSTONE DISEASE | The source population for this cohort study comprised the patients of the UPGRADE trial (Netherlands Trial Register, NL5954), a randomized, multicenter, placebo-controlled, double-blind trial assessing the effect of UDCA on the prevention of symptomatic gallstone disease after bariatric surgery. The protocol, statistic... | PMC10234851 |
Trial Medication | Patients were randomly assigned to either commercially available UDCA 900 mg daily for 6 months (Ursochol 450 mg tablet; two pills once daily) or matching placebo pills. Patients were instructed to start preferably within 2 weeks, but no later than 8 weeks after surgery. An uninterrupted break of up to 4 weeks was allo... | PMC10234851 | ||
Data Collection and Procedures | high-density lipoprotein | PARATHYROID, BLOOD | Clinical data including age, gender, weight, body mass index (BMI) before surgery, comorbidities, and medication use were obtained during hospitalization. Blood tests comprising total bilirubin, alkaline phosphatase (ALP), γ-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), t... | PMC10234851 |
Outcomes and Definitions | hypertension, DM2 | HYPERTENSION, DIABETES MELLITUS TYPE 2, DYSLIPIDEMIA | The primary outcomes were liver enzymes (total bilirubin, ALP, GGT, AST, ALT), lipid spectrum (total cholesterol, LDL, HDL, triglycerides), leukocytes, CRP, and HbA1c levels. Secondary outcomes were blood serum levels and counts of Hb, platelets, PT, total protein, albumin, calcium, PTH, and vitamin D. The definitions ... | PMC10234851 |
Statistical Methods | diabetes mellitus, DM2, dyslipidemia | REGRESSION, DIABETES MELLITUS, DYSLIPIDEMIA | Descriptive statistics were used to summarize patient characteristics. First, we calculated the change in blood values (Δ) between 6 months postoperative and preoperative blood values, i.e., the change after bariatric surgery. To investigate the clinical effect of UDCA, we used the unpaired t-test in the main analysis ... | PMC10234851 |
Changes in Blood Values After Surgery | The changes in blood values after bariatric surgery are shown in Table Changes in laboratory results 6 months after bariatric surgery for 513 patients treated with trial medicationData are shown as mean ± standard deviationAbbreviations: Changes in laboratory results 6 months after bariatric surgery for 316 patients ad... | PMC10234851 | ||
Blood Values After Surgery: Cross-Sectional Comparison | In Table | PMC10234851 | ||
Influence of DM2 and Abnormal Preoperative Blood Values | DM2 | Subsequently, we performed a second sensitivity analysis in patients without DM2. As can be seen in Table Last, we analyzed two subgroups. In adherent patients with preoperative elevated liver enzymes, the same responses were observed after surgery in any of the evaluated blood measurements in 64 patients in the UDCA g... | PMC10234851 | |
ALP in Relation to Calcium Metabolism | REGRESSION | Regression analysis showed that the increase in ALP levels in the total population was correlated with an increase in GGT levels (At 6 months after surgery, ALP levels in the total population were not correlated to vitamin D, PTH, or calcium levels either. A significant correlation was observed between ALP levels and G... | PMC10234851 | |
Discussion | non-alcoholic fatty liver disease, NAFLD, metabolic alterations, overdose, gallstone, inflammation, PBC, weight loss, steatohepatitis | PBC, GALLSTONE, INFLAMMATION, MINOR, NON-ALCOHOLIC FATTY LIVER DISEASE, STEATOHEPATITIS | In this study, we evaluated the effects of UDCA treatment for six months on liver enzymes, lipid profile, glucose level, and inflammatory markers in patients after bariatric surgery. We found a higher increase in mean ALP level in patients who used UDCA compared to patients receiving placebo treatment. No other signifi... | PMC10234851 |
Declarations | PMC10234851 | |||
Ethical Approval | The conduction of the UPGRADE trial was approved by the institutional review board of the Slotervaart Hospital and Reade (Amsterdam, the Netherlands). All procedures performed in the UPGRADE trial were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Hel... | PMC10234851 | ||
Informed Consent | Written informed consent was obtained from all individual participants included in the study.
| PMC10234851 | ||
Conflict of Interest | NNF | Max Nieuwdorp is supported by a ZONMW VICI grant 2020 [number 09150182010020]. Max Nieuwdorp and Victor Gerdes are supported by the NNF GUTMMM grant 2016 NNF15OC0016798. All other authors do not have any conflict of interest. | PMC10234851 | |
References | PMC10234851 | |||
Introduction | anxiety, inflammation, psychiatric, depression, T2DM, Infection | INFLAMMATION, DISEASE, TYPE 2 DIABETES MELLITUS, INSULIN SENSITIVITY, INFECTION | Edited by: Jun Wang, Institute of Microbiology (CAS), ChinaReviewed by: Lin Jin, Kunming Institute of Zoology (CAS), China; Yipeng Wang, Soochow University, China; Xueqing Xu, Southern Medical University, ChinaThis article was submitted to Microbiome in Health and Disease, a section of the journal Frontiers in Cellular... | PMC9922700 |
Materials and methods | PMC9922700 | |||
Subject recruitment | cerebral apoplexy, mental illness, cancer, coronary heart disease, organic diseases, hepatic diseases, T2DM | HEPATIC DISEASE, TYPE 1 DIABETES, ORGANIC DISEASE | This study was a randomized, open-label, parallel-group clinical trial in T2DM patients with a 4-week treatment period. The study was performed according to the principles of the Declaration of Helsinki (2008), and the study protocol was approved by the Ethics Committee of Shanghai Jiao Tong University School of Medici... | PMC9922700 |
Study design | T2DM, Diabetes | DIABETES | After a 2-week washout period, 17 patients clinically diagnosed with T2DM enrolled in the clinical trial and were randomly assigned into two groups using the SAS software. As an open-label, parallel-group study, the control group (n = 8 patients) received usual care, including patient education and dietary recommendati... | PMC9922700 |
Anthropometric measurement and evaluation | HAMD, fasting blood glucose, tumor necrosis, anxiety, Anxiety, depression, Depression, TG | TUMOR NECROSIS | The assessments of fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), serum insulin, C-peptides, triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c), and low-density lipoprotein cholesterol (LDL-c) were detected before and after the treatment. The serum levels of interleuk... | PMC9922700 |
Fecal DNA extraction and high-throughput sequencing | The fecal samples were collected for gut microbiota analysis before and after the treatments. Microbial genomic DNA was extracted using an InviMagH Stool DNA kit referred to the previous study ( | PMC9922700 | ||
Bioinformatics and statistical analysis | The quality control and sequence filtering of raw reads was performed according to the barcode matching and sequence overlapping using QIIME (version 1.9.1). The filtered high-quality reads were clustered into operational taxonomic units (OTUs) with a similarity level of 97%, then the obtained OTUs were used for taxono... | PMC9922700 | ||
Statistical analysis | The data statistical analyses were compared using a one-way analysis of variance (ANOVA) by the SPSS Data Analysis Program (version 17.0; SPSS Inc., Chicago, IL, USA) at the end of each bioassay. All mean comparison was performed using Fisher’s least significant difference test (LSD) with a significance level of | PMC9922700 | ||
Results | PMC9922700 | |||
The glucose homeostasis of participants with T2DM was improved by the high-fiber diet | T2DM | After 8 weeks of intervention, the glucose homeostasis of the treatment group was significantly improved by the high-fiber diet. Compared with the control group, the HbA1c levels and FBG levels of the treatment group decreased significantly, while the levels of serum insulin and C-peptides of the treatment group increa... | PMC9922700 | |
Changes in the serum lipid metabolism profiles | TG, T2DM | To observe the blood lipid profiles influenced by the high-fiber diet, the serum levels of TC, TG, LDL-C and HDL-C were measured and analyzed. Compared with the control group, the serum concentrations of TC, TG and LDL-C in the treatment group were decreased, while the serum levels of HDL-C in the treatment group were ... | PMC9922700 | |
Measurements of serum inflammatory chemokines levels | T2DM | INFLAMMATION | Serum levels of inflammatory chemokine can be used as indicators of systemic inflammation, in this study, four kinds of serum inflammatory chemokines (IL-1β, IL-6, MCP-1 and TNF-α) in the two groups were measured by ELISA detecting methods. Compared with the control group, the serum levels of inflammatory chemokines in... | PMC9922700 |
Evaluations of the depression and anxiety symptom severities | depression, HAMD, anxiety | The depression and anxiety symptom severities were evaluated by HAMA and HAMD questionnaires. The scores of HAMA and HAMD were significantly decreased in patients of the treatment group (Analysis of the mood symptoms. HAMA scores | PMC9922700 | |
Microbial compositional alterations of the gut microbiota | TYPE 2 DIABETES | The raw data obtained from the Illumina MiSeq platform were quality-filtered and demultiplexed to remove invalid and low-quality sequences. A total of 2170797 quality-filtered and chimera-checked sequences were obtained from the 34 samples. The rarefaction curves demonstrated that the sequencing depth was enough for th... | PMC9922700 | |
Discussion | inflammation, diabetic, T2DM | INFLAMMATION, OBESE, OTHER METABOLIC DISORDERS | Previous studies had already proved that the gut microbiota was a critical environmental factor for treating T2DM and other metabolic disorders (Zhao et al. had revealed that the gut microbiota could bring additional health benefits for patients with T2DM through carbohydrate fermentation and SCFA production (Manipulat... | PMC9922700 |
Conclusions | T2DM | In the present study, clinical data indicated that the increased availability of fermentable carbohydrates was sufficient to induce metabolic improvements in patients with T2DM. The dietary source of fibers demonstrated protective impacts on the gut ecosystem, and the alteration of the gut microbiota composition improv... | PMC9922700 | |
Data availability statement | The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found below: | PMC9922700 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Ethics Committee of Shanghai Jiao Tong University School of Medicine. The patients/participants provided their written informed consent to participate in this study. | PMC9922700 | ||
Author contributions | Investigation, LC and LR; software, BoL; methodology, HD, CF, CQ, BiL, and RZ; writing—original draft preparation, ZL; review and editing, HL; supervision, ZM. All authors contributed to the article and approved the submitted version. | PMC9922700 | ||
Conflict of interest | HL | Author HL is employed by Sino-science Yikang Beijing Biotech Co., Ltd.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9922700 | |
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9922700 | ||
References | PMC9922700 | |||
Introduction | LMSs | To stem the spread of COVID-19, public health measures have resulted in the closure of schools and universities. Globally, education systems face unprecedented challenges. Government agencies are collaborating with international organizations, private sector partners, and members of civil society to deliver distance ed... | PMC9821457 | |
Theoretical framework | PMC9821457 | |||
Active learning | Active learning is any learning strategy in which students are actively involved. During active learning, students engage in meaningful learning activities and reflect on their experiences [ | PMC9821457 | ||
Cooperative learning theory | A cooperative learning environment occurs when students work together as part of a group to complete a task [And from the above, It is possible to engage in cooperative learning in three different ways: formally, informally, or in a cooperative base group [ | PMC9821457 | ||
Cognitive load Theory (CLT) | According to the CLT, working memory capacity is one of the most important indicators of effective learning outcomes in a classroom setting. Working memory has a limited capacity. Consequently, complex material, which consists of numerous interconnected elements of information, will be difficult to comprehend. The reas... | PMC9821457 | ||
Instructional Design (ID) models | Educators and designers can incorporate technology into education using a variety of models. In order to create an effective learning design process, developers can use these models as a framework to guide their work, enabling them to produce an effective learning program which focuses on the student rather than the te... | PMC9821457 | ||
ADDIE model [ | The ADDIE model is a popular ID model for creating instructional materials. These five steps are outlined as follows, as seen in | PMC9821457 | ||
The significant differences between the two groups. | PMC9821457 | |||
Materials and methods | PMC9821457 | |||
Ethics statement | The study was conducted in accordance with the ethical standards of the Scientific Research Committee at the Department of Physical Education and Kinesiology, College of Education, Qassim University (Approval No. 11444182022). To obtain informed consent from study participants, the author developed an online Google for... | PMC9821457 | ||
Design | The quasi-experimental method involved creating two groups: one experimental and one control, with the experimental group using Blackboard collaborative breakout groups and the control group relying exclusively on online lectures and continuing with the same method without breakout groups. To determine the extent of th... | PMC9821457 | ||
Study population and sample | The participants were randomly selected from seventh-level students who were enrolled in the Physical Education and Kinesiology Program for men at Qassim University in the second semester of the 2020/2021 academic year and who were registered for the Physical Education Teaching Methods course. There were 69 students in... | PMC9821457 | ||
Descriptive statistics of the control group ( | According to | PMC9821457 | ||
Independent samples compare means. | According to an independent samples t-test, it is clear that there are no statistically significant differences between the experimental and control groups in the variables of age and IQ level, where the value of According to the Mann-Whitney U test, there were no statistically significant differences between the two g... | PMC9821457 | ||
Data collection tools and equipment | PMC9821457 | |||
The high IQ test | The IQ of university students was evaluated in Arabic [ | PMC9821457 | ||
Students’ cognitive achievement test | BLOOM | To achieve the research aim, the researcher designed a cognitive achievement test for students in the teaching physical education styles topic as follows:1- Prepare a table of specification (TOS)Frequently, Bloom’s taxonomy is used to describe behavior goals students should be able to accomplish upon completing their e... | PMC9821457 | |
Difficulty and discrimination index of test items. | 5- ReliabilityCronbach’s alpha was used to calculate the reliability of the test; the result was 0.78, which indicates a high-reliability index. (Scores greater than 0.7 indicate good reliability [ | PMC9821457 | ||
The educational program using blackboard collaborate breakout groups | BLOOM | Through the following steps, ADDIE learning design was used to design learning on the Blackboard collaborate breakout groups platform:1- Analysis: This stage involved determining the general objectives of the program, the characteristics of the students, and the educational activities.
The general objective is to impro... | PMC9821457 | |
Statistical analysis | IBM SPSS Statistics for Windows (2017; version 25; IBM Corp, Armonk, NY, USA) was used for the following statistical analyses: frequencies, percentage (%), mean ( | PMC9821457 | ||
Results | PMC9821457 | |||
Significant differences between the two groups using independent sample T-tests regarding their level of cognitive achievement (n1 = n2 = 20). | PMC9821457 | |||
The significant differences between the post-measurement and the follow-up measurement for the experimental group. | PMC9821457 | |||
Significant differences, statistically, using paired samples T-tests between the post-measurement and the follow-up measurement for the experimental group in the level of cognitive achievement of teaching physical education styles (n = 20). | PMC9821457 | |||
The significant differences between the post-measurement and the follow-up measurement for the control group. | PMC9821457 | |||
Significant differences, statistically, using paired samples T-tests between the post-measurement and the follow-up measurement for the control group in the level of cognitive achievement of teaching physical education styles (n = 20). | PMC9821457 | |||
Discussion | mistakes | According to the results of the first hypothesis, the experimental group outperformed the control group on cognitive achievement of physical education teaching style scores. Because of the experimental group students collaborated with and helped one another, they were more likely to learn physical education teaching st... | PMC9821457 | |
Conclusions | This study explored the effectiveness of Blackboard collaborative breakout groups on physical education teaching styles. According to the results, the experimental group achieved greater cognitive achievement than the control group, which received only online lectures through a Blackboard collaborative ultra. In contra... | PMC9821457 | ||
Limitations | Due to the fact that the Physical Education and Kinesiology program at Qassim University is exclusively for males, all participants in this study were male. It would be possible to explore breakout groups in other online courses with female students. | PMC9821457 | ||
Implications | The development of more active learning strategies is a very imperative thing that needs to be done to increase students’ engagement and the efficiency of online teaching, so that students will be motivated towards online learning in the future. | PMC9821457 | ||
Supporting information | PMC9821457 | |||
The cognitive achievement test of the spectrum of physical education teaching styles. | (DOCX)Click here for additional data file. | PMC9821457 | ||
An example task sheet for organizing experimental breakout groups. | (DOCX)Click here for additional data file.My sincere thanks go out to all the students who participated in the study. | PMC9821457 | ||
References | PMC9821457 | |||
2. Materials and Methods | PMC10458832 | |||
2.1. Study Design, Population, and Products | A multicentre, randomized, double-blind, controlled clinical study was carried out in Italy, in compliance with the Helsinki Declaration (1964) and its amendment. This study’s protocol was approved by the “Independent Ethical Committee for Non-Pharmacological Clinical Studies” (Genova, Italy). Written informed consent ... | PMC10458832 | ||
2.2. Outcome Measures | depression, Depression | The evaluation of depression-related symptoms was carried out by using the Edinburgh Postnatal Depression Scale (EPDS) [The evaluation of breastfeeding quality was performed using the Breastfeeding Self-Efficacy Scale—Short Form (BSES-SF) reported by Rashid et al. [The questionnaires were completed at T1 and T2. At T0,... | PMC10458832 | |
2.3. Statistical Analysis | Statistical analysis was performed using NCSS 10 Statistical Software (version 10.0.7 for Windows; NCSS, Kaysville, UT, USA) running on Windows Server 2008 R2 Standard SP1 64-bit edition (Microsoft, Redmond, WA, USA). The data normality was checked using the Shapiro–Wilk W normality test and data shape. Intergroup (act... | PMC10458832 | ||
3. Results | PMC10458832 | |||
3.1. Depression Symptom Evaluation | depression, Depression | MINOR | The evaluation of depression symptoms was conducted using the Edinburgh Postnatal Depression Scale, after 45 and 90 days of active/control treatment (T1 and T2, respectively). At T1, the active treatment group reached a total score that was underneath the limit of minor depression (i.e., 10 points) with an average scor... | PMC10458832 |
3.2. Breastfeeding Quality Assessment | The breastfeeding quality was determined using the BSES-SF questionnaire filled by subjects after 45 and 90 days of treatment. The active product showed a significant improvement in the average score obtained with respect to control already at T1 (51.46 ± 9.1 vs. 42.80 ± 10.7, respectively, with | PMC10458832 | ||
3.3. Baby’s Crying/Fussing Events | EVENTS | Regarding the daily improvement in crying/fussing events, a positive effect was observed in the group treated with probiotics. At T1, considering the positive answer to item 15 the of the BSES-SF questionnaire (assessing the crying/fussing events during the treatment), 81% of the active group reported an improvement in... | PMC10458832 | |
4. Discussion | anxiety, allergy, ’ mood, weakness, mastitis, depression, allergic diseases | ALLERGY, ALLERGY, SECONDARY, MASTITIS, EVENTS | According to the World Health Organization, stress has been defined as the “Health Epidemic of the 21st Century”. Indeed, the physical and psychological burden caused by long stress periods is increasing [Nowadays, it is well known that probiotic supplementation in women during the last trimester of gestation and breas... | PMC10458832 |
5. Conclusions | The mechanism by which probiotics modulate the mood is still to be clarified; however, growing evidence suggests that probiotics influence the gut–brain axis.The aim of the present study was to further investigate the efficacy of the two probiotics strains in a transitory stress condition, i.e., the postpartum period. ... | PMC10458832 | ||
Author Contributions | Conceptualization, F.V. and V.D.L.; investigation, M.T. and V.D.L.; data curation, M.T. and V.D.L.; writing—original draft preparation, F.V., P.M., M.T. and V.D.L.; writing—review and editing, F.V., P.M., M.T., G.C., L.L. and V.D.L.; supervision, F.V. All authors have read and agreed to the published version of the man... | PMC10458832 | ||
Institutional Review Board Statement | This study was conducted in accordance with the Declaration of Helsinki and approved by the Independent Ethical Committee for Non-Pharmacological Clinical Studies, Genova, Italy (protocol code K.E.HU.NN.NGN00.000.00.00_2019/FV, approved on 13 November 2019). This study was registered at the ISRCTN registry with the fol... | PMC10458832 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in this study. | PMC10458832 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10458832 | ||
Conflicts of Interest | Patrizia Malfa is a Synbalance srl employee. She had no role in the design of this study; the collection, analyses or interpretation of data; she contributed to the writing of this manuscript. | PMC10458832 | ||
References | Depression, crying/fussing | EVENTS, SECONDARY, POSITIVE | Flowchart of this study.Study timeline.Score obtained from the Edinburgh Postnatal Depression Scale questionnaire. Comparison between the active and control products at T1 (Score obtained from the Breastfeeding Self-Efficacy Scale—Short Form (BSES-SF) questionnaire. Comparison between active and control at (Average num... | PMC10458832 |
Introduction | Our recollections tend to become more similar to the correct information when we recollect an initial response using the correct information, known as the hindsight bias [Studies usually investigate hindsight bias in experiments comparing participants’ initial responses with recollection values after providing the corr... | PMC10085031 | ||
Materials and methods | PMC10085031 | |||
Participants and protocol | Participants (N = 63) were assigned to two conditions for the hindsight bias test (HBT); 32 participants (Mean age 22.6 years, SD = 2.93, 20 women) were assigned to the HIGH list (HIGH) and 31 (Mean age 22.8 years, SD = 2.33, 20 women) to the LOW list (LOW) condition. The desired power level was 0.80, and the minimum e... | PMC10085031 | ||
Experimental schedule | Participants arrived at the laboratory between 9 and 10 a.m. and responded to the verbally presented HBT questions in a sound-attenuated room, which were considered their Initial responses. The participants were | PMC10085031 | ||
Compliance with ethical standards | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individua... | PMC10085031 | ||
Data analysis | We defined hindsight bias as the difference between initial responses and recollection values after memorizing the correct information. The percentage of items showing hindsight bias was calculated as the number of biased items divided by all the items, including unbiased items. We defined the two directions of hindsig... | PMC10085031 | ||
Statistics | We omitted absolute values greater than ± 100% from the data analysis as outliers because some data showed extremely large deviance that disturbed parametric analysis. We performed the non-parametric tests in which the full sample set produced similar results to the omitted sample set. The number of omitted data is des... | PMC10085031 |
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