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Study procedures | ICH, diabetes | DIABETES | The ADREM study (Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes) was an open-label, randomised controlled, three-way crossover study, conducted in accordance with the principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act an... | PMC9988601 |
Study participants | hypoglycaemia | TYPE 1 DIABETES, EVENT, HYPOGLYCAEMIA | Adults aged 18–60 years were eligible for participation when they had been diagnosed with type 1 diabetes for at least 2 years, had been treated with a basal-bolus multi-dose insulin regimen for at least 1 year and were at increased risk of hypoglycaemia. The latter was defined as a history of at least one severe hypog... | PMC9988601 |
Screening visit | A schematic overview of the study design is shown in Fig. Overview of the study. Ex, exercise day; Scr, screening visit | PMC9988601 | ||
Exercise days | Each participant engaged in 3 exercise days and was randomly assigned by the investigator to an order of the three post-exercise degludec treatment regimens, i.e. no adjustment of insulin degludec (CON), a 40% dose reduction of degludec (D40) and 8 h postponement with a 20% dose reduction of degludec (D20-P). For D40, ... | PMC9988601 | ||
Study outcomes | EVENTS, EVENT | The primary outcome was the time below range (i.e. glucose <3.9 mmol/l) in the night (00:00–05:59 hours) following the exercise test. Secondary outcomes included times above range (i.e. glucose >10.0 mmol/l) and in range (i.e. glucose ≥3.9 mmol/l and ≤10.0 mmol/l), mean glucose concentration, number of hypoglycaemic an... | PMC9988601 | |
Measurements | Plasma insulin was measured using an in-house radioimmunoassay, using an in-house-generated guinea pig anti-human insulin antibody and | PMC9988601 | ||
Statistical analyses | The sample size estimation was based on the two treatments for which the smallest difference was expected (D40 and CON). Given this was a crossover trial, it was expected that the other comparisons (with D20-P) would have sufficient power. No ɑ corrections were made to account for the multiple comparisons. Furthermore,... | PMC9988601 | ||
Results | SD | HYPOGLYCAEMIA | A total of 19 participants were screened, 18 of whom were included. One participant was withdrawn after screening because of personal reasons unrelated to the study. All 18 included participants completed the study. Their baseline characteristics are shown in Table Baseline characteristicsData are presented as number (... | PMC9988601 |
Exercise tests | ST-segment depression | The three 45 min exercise tests were performed consistently across all treatment groups regarding heart rate (CON 144 ± 3, D40 145 ± 3, D20-P 144 ± 3 beats per minute). All participants cycled at 70% of their heart rate reserve, except for one participant, who cycled all three tests at 57% heart rate reserve because of... | PMC9988601 | |
Study outcomes | PMC9988601 | |||
Time below range and hypoglycaemic events | Time below range in the night after the exercise test was generally low and occurrence did not differ significantly between the treatment regimens (three participants in CON, one in D40, three in D20-P). The day after the exercise test, time below range was greater for CON compared with D40 (18 [0–55] vs 0 [0–23] min, | PMC9988601 | ||
Mean glucose concentration | No differences in mean glucose concentration were found between the treatment regimens the night after the exercise test (Fig. Time course of the mean glucose concentration over the first ( | PMC9988601 | ||
Time above range | No differences in time above range were found between the treatment regimens the night after the exercise test. The day after the exercise test, D20-P led to significantly more time above range (584 ± 81 min) compared with CON (364 ± 66 min, Percentage of time spent above range, in range and below range the first night... | PMC9988601 | ||
Time in range | The night following the exercise test, D20-P was associated with less time in range compared with D40 (229 ± 30 vs 287 ± 26 min, | PMC9988601 | ||
Sensitivity analyses | Repeating the analyses according to the actual sleep times of the participants did not materially change the results, except that the night after the exercise test, the mean glucose concentration was higher for D20-P compared with CON (9.8 ± 0.8 vs 8.5 ± 0.5 mmol/l, | PMC9988601 | ||
Fasting ketones | Fasting ketones in the morning after the exercise tests were generally low (all ≤0.8 mmol/l), but were significantly higher for D20-P than D40 (0.27 ± 0.04 vs 0.16 ± 0.03 mmol/l, | PMC9988601 | ||
Short-acting insulin and carbohydrate intake | HYPERGLYCAEMIA, EVENT, HYPOGLYCAEMIA | The evening after the exercise test, three people (17%) in CON, one (6%) in D40 and one (6%) in D20-P injected additional short-acting insulin because of profound hyperglycaemia. During this evening, nine people (50%) in CON, five (28%) in D40 and two (11%) in D20-P ingested additional carbohydrates to prevent hypoglyc... | PMC9988601 | |
Discussion | generalised, hypoglycaemia | EVENTS, TYPE 1 DIABETES, NOCTURNAL HYPOGLYCAEMIA, HYPOGLYCAEMIA | The main finding of this study is that adjustment of insulin degludec dosing after aerobic exercise performed in the afternoon had no effect on the incidence of subsequent nocturnal hypoglycaemia in people with type 1 diabetes. While next-day time below range was slightly reduced in the 40% dose reduction group, this d... | PMC9988601 |
Supplementary information |
(PDF 450 kb) | PMC9988601 | ||
Acknowledgements | Diabetes | DIABETES | The authors thank all volunteers for their participation. The authors also express their gratitude to B. Kersten and E. Bakker from the Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands, for assistance during the exercise tests and with analysing activity tracker data, respectively.... | PMC9988601 |
Authors’ relationships and activities | BEdG is associate editor for | PMC9988601 | ||
Contribution statement | EJA, CJT and BEdG designed the study. LCAD recruited the participants, performed the experiments, collected the data, analysed the data and wrote the first version of the manuscript. LCAD, MA and LR performed the statistical analyses. All authors discussed the results and implications, commented on the manuscript at al... | PMC9988601 | ||
Funding | Nordisk | This study was conducted with an unrestricted grant from Novo Nordisk, Denmark. Novo Nordisk was not involved in the collection, analyses and interpretation of data, nor in writing the report and the decision to submit for publication. | PMC9988601 | |
Data availability | The datasets generated during and/or analysed in the current study are available from the corresponding author upon reasonable request. | PMC9988601 | ||
References | PMC9988601 | |||
Subject terms | Mediolateral weight-shifting is an important aspect of postural control. As it is currently unknown whether a short training session of mediolateral weight-shifting in a virtual reality (VR) environment can improve weight-shifting, we investigated this question and also probed the impact of practice on brain activity. ... | PMC10638445 | ||
Introduction | Weight-shifting constitutes an important component of dynamic postural control, which refers to the ability to keep one’s bodyweight within the base of supportMost studies on learning-induced neural activation changes have focused on upper extremity tasksFunctional Near-Infrared Spectroscopy (fNIRS) is a mobile neuroim... | PMC10638445 | ||
Results | Some missing data were apparent due to recording problems (once due to the fNIRS-cap and once due to the wasp game). One participant in EXP was not willing to perform the DT condition, and one participant in CTR found the fNIRS system uncomfortable at retention. | PMC10638445 | ||
Participant characteristics | SD | Participants were recruited, trained and tested between January 4th and June 16th, 2021. Forty-three healthy older adults were initially recruited for participation, as three participants had to be excluded after signing the informed consent. Two did not meet the in/exclusion criteria (one had a MoCA score below 26 and... | PMC10638445 | |
Behavioral results | PMC10638445 | |||
Training effects on weight-shifting performance in ST | Significant time by group interactions were revealed for all three outcomes (speed: F( | PMC10638445 | ||
Training effects on weight-shifting performance in DT | When adding the cognitive DT to the weight-shifting assessments, a comparable pattern of interaction effects was found (speed: F | PMC10638445 | ||
Training effects on functional limits of stability and overall balance | Figure Functional limits of stability (fLOS) for the ( | PMC10638445 | ||
fNIRS results | PMC10638445 | |||
Training effects on cortical hemodynamics | Cortical hemodynamics during ST showed a significant interaction effect for the SMA left (F(fNIRS HbOValues are displayed as mean ± SD (μmol/L). Bold values indicate statistical significance and effect sizes of significant post-hoc tests. Note that only within-group time effects were explored post-hoc. | PMC10638445 | ||
Exploratory analyses | To determine which people responded best to training, correlation analyses were conducted and revealed that participants in EXP who had a better overall balance at baseline (higher MiniBEST score) also tended to have a larger ST speed improvement from pre-assessment to 24 h-retention (r = 0.456, p = 0.043, see Suppleme... | PMC10638445 | ||
Discussion | BLIND | This is the first study that investigated whether a single-session VR-based balance training led to changes in weight-shifting behavior and brain activity in older adults. Older adults were able to improve their weight-shifting capacity after the session during ST and DT test-conditions, the latter reflecting that the ... | PMC10638445 | |
Materials and methods | PMC10638445 | |||
Participants | chronic musculoskeletal problems, balance impairments, cardiovascular or respiratory disease, diabetes | DIABETES, MAY, NEUROLOGICAL DISORDERS | In total, we recruited forty-three healthy older adults through our local GDPR-proof databases, of which forty were included in the actual study protocol. Participants had to be able to stand upright for a minimum of 5 min without using an aid and were excluded if they presented any medical problems that could influenc... | PMC10638445 |
Experimental procedure and tasks | PMC10638445 | |||
Procedure | This randomized controlled trial was pre-registered at clinicaltrials.gov (ID: NCT04594148, first registration: 20/10/2020, including full trial protocol) and consisted of two test sessions at the Movement and Analysis Laboratory Leuven (MALL). Healthy older adults were randomly allocated to either the training (EXP, n... | PMC10638445 | ||
Interventions | Mediolateral weight-shift training was performed via a VR wasp game (see Supplementary Fig. The 25-min training was divided into 10 blocks of 2.5 min with a 30 s rest period in between blocks. A longer break of 2 min was provided after five blocks with the opportunity to rest on a chair. Participants were instructed to... | PMC10638445 | ||
Weight-shifting assessment | Weight-shifting assessments were performed at pre, post and retention. For this purpose, the wasp game was executed in both single- (ST) and dual-task (DT) conditions. During DT, participants had to perform serial subtractions in threes, while hitting the wasps (see Supplementary Fig. | PMC10638445 | ||
fNIRS assessment | BRAIN | Brain hemodynamics were captured with the continuous wave, single-phase NIRSport2 system (NIRx, Berlin, Germany), with LED wavelengths of 760 and 850 nm and a sampling frequency of 7.81 Hz, following consensus guidelines | PMC10638445 | |
Cognitive assessment and other descriptors | sarcopenia | SARCOPENIA | After the experimental procedures on day 2, participants performed a descriptive test battery. We used the MoCA for assessment of cognitive ability. Other questionnaires included the Falls Efficacy Scale International (FES-I) to assess concern about falling, the sarcopenia questionnaire (SARC-F) and the Pittsburgh Slee... | PMC10638445 |
Data processing | PMC10638445 | |||
Weight-shifting data | Matlab 2018b (Mathworks, MA, USA) was used to process the CoM data as calculated in real time within the D-Flow software | PMC10638445 | ||
fNIRS data | CORTEX | fNIRS data were imported into Matlab (version 2018b, Mathworks, MA, USA) and analyzed using the NIRS toolbox (open access; Visually checking raw signals and resampling signals to 5 Hz. Converting raw signals into optical density using the Beer–Lambert law for which a partial path length correction factor of 0.1 was us... | PMC10638445 | |
Statistical analysis | An a-priori sample size calculation (see clinicaltrials.gov, ID: NCT04594148) determined that we required 40 participants (20 per group). However, during data analyses, an error was found in that calculation, so an additional sensitivity power analysis was performed. From this, we determined that our sample of 40 is su... | PMC10638445 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-46645-4. | PMC10638445 | ||
Acknowledgements | A special word of thanks is direction towards Marie Bogaerts, Annelien Loverix, Hanne Vandenbossche and Ella Copermans for their crucial involvement during data collection. Above all, the authors are grateful for the enthusiastic contributions of all participants, without whom this study would not have been possible. T... | PMC10638445 | ||
Author contributions | RECRUITMENT | V.R. was responsible for the recruitment, data collection, data analysis and writing of the manuscript. N.D. contributed to the data and statistical analysis. F.H. helped with the data collection and data analysis. C.M. contributed to the sample size calculation and manuscript revisions. S.V. provided the infrastructur... | PMC10638445 | |
Data availability | The datasets generated for this study will be made available upon reasonable request, which should be directed to the corresponding author. | PMC10638445 | ||
Competing interests | The authors declare no competing interests. | PMC10638445 | ||
References | PMC10638445 | |||
Objectives | DIE, EH | ENDOMETRIAL HYPERPLASIA | To compare the effectiveness of dienogest (DIE) and norethisterone acetate (NETA) regimens in the treatment of endometrial hyperplasia (EH) without atypia. | PMC10348941 |
Methods | DIE, irregular uterine bleeding | ENDOMETRIAL HYPERPLASIA WITHOUT ATYPIA | Participants were premenopausal women with irregular uterine bleeding, and endometrial hyperplasia without atypia on endometrial biopsy. Enrolled patients were randomly allocated into two groups: group I got DIE 2 mg/day (orally Visanne) for 14 days (10th to the 25th day of cycle) while group II received between the 16... | PMC10348941 |
Results | DIE | REGRESSION | The DIE group showed a higher resolution (32.7%) and regression (57.7%) than NETA group (31% & 37.9%, respectively) with significant regression ( | PMC10348941 |
Conclusion | REGRESSION | If used as first-line treatment, Dienogest produces a better rate of regression and a lower incidence of hysterectomy than Norethisterone Acetate does when used in EH without atypia. | PMC10348941 | |
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10348941 | ||
What does this study add to the clinical work | PMC10348941 | |||
Introduction | irregular uterine hemorrhage, endometrial cancer, endometriosis, hyperplasia, DIE, cancer, endometrial hyperplasia, amenorrhea, weight gain, acne | ENDOMETRIAL CANCER, ENDOMETRIOSIS, HYPERPLASIA, CELLULAR ATYPIA, ENDOMETRIAL HYPERPLASIA, CANCER, ENDOMETRIAL HYPERPLASIA, ACNE, CYTOLOGIC ATYPIA | Endometrial hyperplasia, which may lead to endometrial cancer or coexist with it, is characterized by an excessive growth of the endometrial glands [Although this ailment is often detected during the postmenopausal stage, it may occur at any age as long as the person is exposed to estrogen. The most significant risk fa... | PMC10348941 |
Patients and methods | PMC10348941 | |||
Study design and inclusion criteria | endometrial hyperplasia, abnormal endometrial thickness, abnormal uterine hemorrhage | ENDOMETRIAL HYPERPLASIA, ABNORMAL UTERINE HEMORRHAGE, ENDOMETRIAL HYPERPLASIA WITHOUT ATYPIA | A prospective controlled study of premenopausal women between the ages of 41 and 53 who were hospitalized to the Obstetrics and Gynecology Department at Zagazig University between January 2020 and October 2021 with abnormal uterine hemorrhage and persistent pelvic discomfort participated in an interventional prospectiv... | PMC10348941 |
Exclusion criteria | liver, kidney, heart, diabetes, AUB, breast cancers, hyperplasia | ABNORMAL UTERINE BLEEDING, BREAST CANCER, HYPERPLASIA, LEIOMYOMA, THROMBOEMBOLIC DISEASE | However, those with localized endometrial lesions like leiomyoma or atypical or complicated hyperplasia who have had hormone treatment within the last six months are at higher risk and other causes of abnormal uterine bleeding (AUB) like adnexal swellings and genital and breast cancers were excluded. Also, patients wit... | PMC10348941 |
Interventions | DIE, abnormal endometrial thickness | STERILE, PROLIFERATIVE, REGRESSION, PATHOLOGY, ATROPHIC | Enrolled patients were randomly allocated into two groups; group I got DIE 2 mg/day (orally Visanne; bayer pharma, Cairo, Egypt) for 14 days (10th to the 25th day of cycle) while Between the 16th and 25th day of the cycle, group II got norethisterone acetate (NETA) 15 mg/d (orally Primolut Nor; Hi Pharma, Cairo, Egypt)... | PMC10348941 |
Statistical analysis | SD | On an IBM compatible computer, the acquired data were tabulated and analyzed utilizing SPSS (statistical software for social research), version 25 (IBM, Armonk, NY, USA). Quantitative continues group represents by mean ± SD and compared between them by independent t test and paired t test while qualitative represents a... | PMC10348941 | |
Discussion | Endometrial hyperplasia | ENDOMETRIAL HYPERPLASIA, UTERUS | Endometrial hyperplasia is a widespread condition. Particularly in Arab nations, the uterus is seen as a sign of women and femininity. Her psychological state will be greatly impacted by having her uterus removed. Therefore, every effort must be made to maintain the uterus as much as possible. | PMC10348941 |
Main findings | DIE | To the extent that we are aware, there is insufficient data regarding effect of DIE in EH without atypia and our study is a unique one to compare its effect versus NETA as a conventional treatment of EH. | PMC10348941 | |
Strengths and limitations | The main limitation of research was the small size of study groups, and the factors strengthen the study, the prospective nature of study and use of inclusion and exclusion criteria with coding of the data collected for proper interpretation. | PMC10348941 | ||
Interpretation | irregular bleeding, mastalgia, DIE, cancer, nausea &vomiting | REGRESSION, CANCER | A fourth-generation progestin called DIE was employed in hormone replacement treatment and contraceptive pills [It is well known that progestins speed up the signaling pathways that prevent endometrial cells from undergoing cancer development [A research by Kodama et al. [Ozdegirmenci et al. [In the current study, we u... | PMC10348941 |
Acknowledgements | PATHOLOGY | Thank you to the pathology and gynecological team for their cooperation. | PMC10348941 | |
Author contribution | EFG: study design, writing and share in gynecological work up of study. HMA: share in gynecological work up of study. HES: collect the study groups and share in writing of study. AMR: share in writing of study and share in gynecological work up of study. | PMC10348941 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). The research, writing, and/or publishing of this work were all done without any financial assistance from the authors. | PMC10348941 | ||
Data availability | Data available on reasonable request. | PMC10348941 | ||
Declarations | PMC10348941 | |||
Conflict of interest | No conflicts of interest. | PMC10348941 | ||
Ethical approval | Before enrolling in our trial, we obtained written informed permission from every participant, and they were all free to withdraw at any moment throughout follow-up. The Faculty of Medicine at Zagzig University in Egypt's Institutional Review Board and ethics committee gave their approval to the study's protocol. | PMC10348941 | ||
References | PMC10348941 | |||
Background | obesity | OBESITY | Mandatory calorie labelling in the out-of-home food sector was introduced in England in 2022, and menu pricing strategies that ensure cost is equivalent to portion size (proportional pricing) have been proposed as a policy to reduce obesity. Food delivery app-based platforms now contribute significantly to diet, and ev... | PMC10508026 |
Objective | This experimental study assessed the impact of calorie labelling and proportional pricing on item and meal size selection, calories ordered, and money spent when selecting food and drinks from three outlet types on a virtual delivery app. | PMC10508026 | ||
Methods | SHOP | UK adult participants (N = 1126, 49% female), stratified by gender and education level completed an online study where they ordered items from three branded food and beverage outlets (coffee shop, sandwich outlet, fast food outlet) using a virtual delivery app. Participants were presented food and beverage options with... | PMC10508026 | |
Results | SHOP | Calorie labelling did not influence portion size selection for any outlets, but significantly reduced calories ordered from the coffee shop (-18.95kcals, 95% CI -33.07 to -4.84) and fast food outlet (-54.19kcals, 95% CI -86.04 to -22.33). Proportional pricing reduced the likelihood of choosing a larger beverage from th... | PMC10508026 | |
Conclusions | Calorie labelling on food delivery platforms may effectively reduce calories ordered. Proportional pricing may be useful in prompting consumers to select smaller portion sizes, although further research in real-world settings will now be valuable. | PMC10508026 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12966-023-01513-2. | PMC10508026 | ||
Keywords | PMC10508026 | |||
Introduction | Globally, there has been an increase in the presence, and use of food delivery platforms [Food prepared outside the home, whether from fast food, takeaway, or full service restaurants is typically greater in energy than food prepared at home [In the UK, public health strategies to improve the nutritional quality of foo... | PMC10508026 | ||
Methods | PMC10508026 | |||
Study sample | RECRUITMENT | Participants (final N = 1126) were recruited through the online research platform Prolific [
Adapted consort flowchart of participant recruitment through to completion | PMC10508026 | |
Design | RECRUITMENT | This study used a 2 × 2 between-subjects design. Upon recruitment, participants were randomly assigned to one of four experimental conditions: calorie labels and value pricing; calorie labels and proportional pricing; no calorie labels and value pricing; no calorie labels and proportional pricing. Participants were rec... | PMC10508026 | |
Demographic and participant characteristic measures | Online questionnaires collected self-reported data on gender, age, ethnicity, height, weight, and SEP. The primary measure of SEP was the highest educational level achieved, for which there were six options (less than high school, high school completion, college or foundation degree, bachelor’s degree, master’s degree,... | PMC10508026 | ||
Food choice motives | After completing orders from all three food outlets (described below), participants were presented with subscales of the Food Choice Motives Questionnaire [ | PMC10508026 | ||
Virtual delivery app | HAND PRESENTATION, SHOP | A virtual delivery app (Supplementary material II) was created using the program Inquisit 6, and modelled on a popular UK-based food delivery platform. Three large chain food outlets in the UK (a coffee shop, a sandwich shop, and a fast food outlet) were simulated as they each typically offer products at a larger size ... | PMC10508026 | |
Other measures | After providing consent, participants were asked to guess the aim of the study. Guesses relating to kcals/calorie information on food choice or food price on food choice were coded as correctly guessed. Aim guessing was coded independently by two authors (AF, RM) and inconsistencies were resolved through discussion or ... | PMC10508026 | ||
Procedure | thirst | After providing consent, participants were randomly assigned to one of the four conditions. Baseline demographic data were collected, and participants completed items on how frequently food apps generally, and the three simulated food outlets in the study, were used by participants. Participants next completed hunger a... | PMC10508026 | |
Analysis | We followed a pre-registered analysis strategy (osf.io/kaju5 [ | PMC10508026 | ||
Primary analyses | REGRESSIONS | Primary outcomes for this study were size choice (medium or large), hypothetical kcals ordered, and hypothetical money spent from each outlet. For each outlet, binary logistic regressions were used to examine the association between calorie labelling condition (present/absent) and pricing condition (proportional/value)... | PMC10508026 | |
Unplanned additional analyses | REGRESSION | Data from the three outlets were combined to examine any overall effects of calorie labelling condition and proportional pricing condition across the three outlet types. For size choice, participants were given a score of 0 to 3 according to the number of times they selected a larger portion size. A linear regression m... | PMC10508026 | |
Secondary analyses | INTERACTIONS, SECONDARY | Interactions between participant characteristics (BMI, education, food choice motives, age, gender and ethnicity) and experimental conditions were investigated at a second step in each of the models outlined in the primary analyses. Results for secondary analyses were considered significant at p < .01 to account for mu... | PMC10508026 | |
Sensitivity analyses | SENSITIVITY | Sensitivity analyses (Supplementary Material VI) revealed that results were largely the same whether subjective social status or equivalised household income were used in place of highest education level as a measure of SEP. Additional sensitivity analyses identified no differences in significance for primary findings ... | PMC10508026 |
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