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Materials and methods
GDM
GDM
This was a non-blinded, randomised controlled trial, that recruited 100 pregnant women diagnosed with GDM between 24 and 28 weeks of gestation at the 1st Department of Obstetrics and Gynaecology, Medical University of Warsaw. After meeting the inclusion criteria patients were randomly allocated to the study group (FGM,...
PMC10359198
Results
There was no significant difference in mean glycaemia between the groups (
PMC10359198
Supplementary Information
The online version contains supplementary material available at 10.1007/s00592-023-02091-2.
PMC10359198
Keywords
PMC10359198
Introduction
hyperglycaemia, GDM
GDM, HYPERGLYCAEMIA, GESTATIONAL DIABETES MELLITUS
Gestational diabetes mellitus (GDM) is the most common type of hyperglycaemia in pregnancy, with the incidence rate of 14% varying worldwide [
PMC10359198
Materials and methods
macrosomia, weight gain, GDM
EVENTS, RECRUITMENT, GDM, SECONDARY, NEONATAL HYPOGLYCAEMIA, HYPERGLYCAEMIA
We performed a non-blinded, randomised controlled trial between March 2020 and October 2022, that recruited 100 pregnant women diagnosed with GDM between 24 and 28 weeks of gestation at the 1st Department of Obstetrics and Gynaecology, Medical University of Warsaw. A diagnosis of GDM was based on 2013 World Health Orga...
PMC10359198
Sample size calculation
We performed a two-sided power analysis (power of 80%, significance level of 5%) and estimated a sample size of 80 patients (40 patients for each group). The sample size was further increased to 100 patients based on estimated drop-out rate of 10% participants. For the estimation, we used results of a previous study co...
PMC10359198
Statistical analysis
REGRESSION
The statistical analysis was carried out using STATA, version 17.0 (Stata Corporation, TX, USA) and GraphPad Prism v9 (GraphPad Software, CA, USA). Continuous variables were presented as means ± standard deviation (SD) or medians ± interquartile range (IQR) and categorical variables were presented as frequencies (%) by...
PMC10359198
Results
PLACENTA PRAEVIA, RECRUITMENT
Between March 2020 and October 2022, we recruited 100 patients that met the inclusion criteria. 50 patients were recruited to the study group, out of which 49 completed the study (one patient was excluded after recruitment process at the first follow up visit due to diagnosis of placenta praevia). 50 patients were allo...
PMC10359198
Primary outcome
GDM
GDM, GESTATIONAL DIABETES MELLITUS
There was no significant difference in mean (SD) fasting glucose concentration during the first 4 weeks following GDM diagnosis between the groups (Glycaemic control in the first 4 weeks following inclusion to the studyDelta mean glucose concentrations were significantly reduced in the study group in comparison to the ...
PMC10359198
Secondary outcomes
macrosomia, weight gain
EVENT, RECRUITMENT, NEONATAL HYPOGLYCAEMIA, REGRESSION, EVENTS, APPENDIX
FGM enabled to reveal all nocturnal hypoglycaemic events during the first month of the study in the study group (mean incidence of 15 events/month). In 6 out of 49 patients (12.24%) we recorded one episode of hypoglycaemic event level 2 (glucose concentration less than 54 mg/dl). We were not able to compare it with the...
PMC10359198
Discussion
pre-gestational diabetes, macrosomia, diabetes, GDM, weight gain, hypoglycaemia
GESTATIONAL DIABETES MELLITUS, RECRUITMENT, GDM, DIABETES, NEONATAL HYPOGLYCAEMIA, EVENTS, HYPOGLYCAEMIA
Our study revealed, that FGM might improve glycaemic control, when compared to SMBG. Although mean glycaemia did not differ significantly between the groups, and when separately analysed, postprandial glycaemia was significantly lower in the control group, glycaemia through the first month of the study improved more si...
PMC10359198
Conclusions
macrosomia, weight gain, GDM
GDM, NEONATAL HYPOGLYCAEMIA
In summary, FGM application resulted in significantly better improvement in glycaemic control in the 3rd and 4th week of the study. FGM led to higher EAT score, that might indicate better diet modifications after GDM diagnosis; however, it had no impact on lifestyle interventions including gestational weight gain, qual...
PMC10359198
Acknowledgements
RECRUITMENT
Thank you to our colleagues from the 1st Department of Obstetrics and Gynaecology, Medical University of Warsaw for helping us in the recruitment process.
PMC10359198
Authors’ contributions
PJS
AM, PJS, BW and DBO conceived and planned the study. AM, PJS, JT, IR, MW and DBO recruited the participants to the study. AM, PJS, JT and DBO conducted the study and collected essential data. AM analysed data. AM, PJS and DBO drafted the manuscript. PJS and DBO revised the manuscript. All authors have contributed to re...
PMC10359198
Funding
This study did not receive any funding from the public or commercial sector.
PMC10359198
Declarations
PMC10359198
Conflict of interest
The authors declare that they have no conflict of interest.
PMC10359198
References
PMC10359198
1. Introduction
obesity, metabolic syndrome, Obesity, TG
OBESITY, OBESITY, CARDIOVASCULAR DISEASES, INSULIN RESISTANCE, METABOLIC SYNDROME, TYPE 2 DIABETES, DISEASES
The aim of this study was to investigate the effects of 12 weeks of high-intensity training with astaxanthin supplementation on adipokine levels, insulin resistance and lipid profiles in males with obesity. Sixty-eight males with obesity were randomly stratified into four groups of seventeen subjects each: control grou...
PMC9866205
2. Materials and Methods
After calling in public places such as gyms, medical clinics, hospitals and social networks, there were 101 participants who initially volunteered for the study, of whom 33 were ineligible, leaving 68 participants in the study (mean age: 27.6 ± 8.4 yrs; mean height: 167.8 ± 3.1 cm; mean weight: 94.7± 2.0 kg; mean BMI: ...
PMC9866205
2.1. Experimental Design
One week prior to the start of the training programs, the study procedures were explained and a familiarization session was completed by all participants. Height, weight, and body composition were assessed for all the participants, who were then randomly assigned into one of four equal groups (
PMC9866205
2.2. Body Composition and Cardio-Respiratory Fitness Assessments
Body weights and heights were measured using a calibrated scale (Seca GmbH & Co., Hamburg, Germany) and stadiometer (Seca GmbH & Co., Hamburg, Germany), respectively. Then, the body mass index (BMI, kg/m
PMC9866205
2.3. Training Protocols
In the current study, a total of 36 sessions lasting up to 60 min each were included in the HIFT program using CrossFit. Crossfit training is stratified as high-intensity functional training with a mixed model of concurrent strength and endurance performance often containing various fitness components [
PMC9866205
2.4. Supplementation of Astaxanthin and Placebo
Eligible participants in the SG and TSG received 20 mg/day of astaxanthin capsule (Marine Product Tech. Inc., Seongnam, Republic of Korea) or matching placebo capsule (20 mg/day of raw corn starch) once daily with breakfast for 12 weeks. Participants were considered adherent when ≥80% of their prescribed supplements we...
PMC9866205
2.5. Nutrient Intake and Dietary Analysis
Before and after the experiment changes in habitual dietary intake over time were determined using three-day food records (two weekdays and one weekend day) [
PMC9866205
2.6. Assessment of Blood Markers
MDD, TG
BLOOD, SENSITIVITY
Fasting blood samples were taken under standard conditions between 8 and 10 am from the right arm 12 h before the first exercise session and 72 h after the last session. Blood samples were transferred to EDTA-containing tubes, centrifuged for 10 min at 3000 rpm, and stored at −70 °C for later use for the following meas...
PMC9866205
2.7. Statistical Analysis
Descriptive statistics (means ± standard deviation) were used to summarize all data. The normality of the data was assessed by the Shapiro–Wilk test. A two-way ANOVA repeated measures test was used to determine group X time interactions. One-way ANOVA and Fisher LSD post-hoc tests were used for evaluation of baseline d...
PMC9866205
3. Results
PMC9866205
3.1. Anthropometric Characteristics and Cardio-Respiratory Parameters
There were no between-group differences in baseline values for weight (Changes in BMI after 12 weeks were significantly decreased in the SG (
PMC9866205
3.2. Lipid Profiles
There were no significant differences in the baseline levels of HDL (
PMC9866205
3.3. Metabolic Factors
There were no significant differences in baseline levels of glucose (
PMC9866205
3.4. Adipokines and Growth Differentiation Factors
TG
There were no significant differences in baseline levels of CTRP9 (A comparison of pre-test and post-test values indicated no differences in CTRP9 (The analysis of between-group differences for CTRP9 indicated a significance in TG (The decreases of CTRP2 in the SG (GDF8 decreased significantly in the SG (GDF15 signific...
PMC9866205
4. Discussion
obesity, obese, overweight
OBESITY, OBESE, INSULIN RESISTANCE
We examined the effects of 12 weeks of HIFT that was supplemented with astaxanthin on adipokine levels, insulin resistance and lipid profiles in males with obesity. Our findings indicate that 12 weeks of CrossFit exercise training supplemented with astaxanthin: (A) reduced anthropometric indices (body weight, BMI, FFM,...
PMC9866205
5. Conclusions
obesity
OBESITY
Our findings indicate that 12 weeks of astaxanthin supplementation and exercise training decreased adipokines levels, body composition (weight, %fat), anthropometrical factors (BMI), and improved lipid and metabolic profiles. These benefits were greater in men with obesity who exercised and used astaxanthin supplementa...
PMC9866205
Author Contributions
All authors contributed equally to data collection. They read and approved the final manuscript. Finally, all authors agreed to be accountable for all aspects of the work. All authors have read and agreed to the published version of the manuscript.
PMC9866205
Institutional Review Board Statement
All procedures were performed according to the latest revision of the Declaration of Helsinki. The Research and Ethics Committee of the Islamic Azad University approved all procedures of this study (Ethics code: IR-IAU1400-47, 8 July 2021).
PMC9866205
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC9866205
Data Availability Statement
The data presented in this study are available within the manuscript.
PMC9866205
Conflicts of Interest
The authors declare no conflict of interest.
PMC9866205
References
TG
INSULIN RESISTANCE
Pre- and post-training values (mean ± SD) for CTRP9 in the control (CG), supplement (SG), training (TG), training + supplement (TSG) groups. Pre- and post-training values (mean ± SD) for CTRP2 in the control (CG), supplement (SG), training (TG), training + supplement (TSG) groups. Pre- and post-training values (mean ± ...
PMC9866205
Abstract
PMC10583133
Objective
To assess the clinical effectiveness of septoplasty.
PMC10583133
Design
Multicentre, randomised controlled trial.
PMC10583133
Setting
17 otolaryngology clinics in the UK’s National Health Service.
PMC10583133
Participants
Nasal Obstruction, nasal obstruction
378 adults (≥18 years, 67% men) newly referred with symptoms of nasal obstruction associated with septal deviation and at least moderate symptoms of nasal obstruction (score >30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale).
PMC10583133
Interventions
Participants were randomised 1:1 to receive either septoplasty (n=188) or defined medical management (n=190, nasal steroid and saline spray for six months), stratified by baseline symptom severity and sex.
PMC10583133
Main outcome measures
nasal airflow
The primary outcome measure was patient reported score on the Sino-Nasal Outcome Test-22 (SNOT-22) at six months, with 9 points defined as the minimal clinically important difference. Secondary outcomes included quality of life and objective nasal airflow measures.
PMC10583133
Results
bleeding, infections, nasal airflow
BLEEDING, INFECTIONS
Mean SNOT-22 scores at six months were 19.9 (95% confidence interval 17.0 to 22.7) in the septoplasty arm (n=152, intention-to-treat population) and 39.5 (36.1 to 42.9) in the medical management arm (n=155); an estimated 20.0 points lower (better) for participants randomised to receive septoplasty (95% confidence inter...
PMC10583133
Conclusions
nasal obstruction
Septoplasty is a more effective intervention than a defined medical management regimen with a nasal steroid and saline spray in adults with nasal obstruction associated with a deviated nasal septum.
PMC10583133
Trial registration
ISRCTN Registry ISRCTN16168569.
PMC10583133
Introduction
nasal airflow, nasal obstruction
Septoplasty is a common operation to alleviate nasal obstruction associated with deviation of the nasal septum. It may be accompanied by reduction of the inferior turbinate to increase airflow through the nasal cavities. Surgery is typically predicated on clinical history and a visual assessment of the nasal septum. To...
PMC10583133
Methods
The Nasal Airways Obstruction Study was a multicentre, non-adaptive, open label randomised controlled trial conducted in 17 hospitals in the UK’s NHS. The regional ethics committee approved the trial protocol.
PMC10583133
Participants
Nasal Obstruction, nasal obstruction
Participants were adults (≥18 years) newly referred to otolaryngology clinics with symptoms of nasal obstruction associated with septal deviation and confirmed by endoscopic assessment. Participants were offered entry into the trial if their presenting Nasal Obstruction and Symptom Evaluation (NOSE)
PMC10583133
Randomisation
The Newcastle Clinical Trials Unit Randomisation Service, an in-house bespoke internet based system, performed randomisation centrally using permuted random blocks of variable length. All allocations were generated by an automated process within the system. Participants were randomised 1:1 to receive either surgical in...
PMC10583133
Interventions
PMC10583133
Outcome measures
PMC10583133
Primary outcome measure
CHRONIC RHINOSINUSITIS
The primary outcome measure was the score on the Sino-Nasal Outcome Test (SNOT-22) at six months (defined protocol time window −2 to 4 weeks for completion). SNOT-22 is a patient reported outcome measure that has been validated to assess symptoms related to chronic rhinosinusitis
PMC10583133
Secondary outcome measures
ear/facial pain
SECONDARY
Four secondary patient reported outcome measures were assessed:• SNOT-22 score at 12 months.• SNOT-22 subscale (nose, sleep, ear/facial pain, psychological) score at baseline, six months, and 12 months.• Score on the NOSE scale at baseline, six months, and 12 months.• General quality of life, measured at baseline, six ...
PMC10583133
Statistical analysis
inferior turbinate reduction, airway blockage, enlargement of the inferior turbinate
REGRESSION, SECONDARY, RECRUITMENT
Analyses were performed according to a predetermined analysis plan.The planned population defining analyses included an ITT analysis, a per protocol analysis, and a per treatment analysis. We explored the impact of the recruitment site on the primary outcome analysis by inserting the centre as a random effect with th...
PMC10583133
Missing data
SNOT-22 questionnaires with up to 20% of items missing were imputed with the average of the completed questions used for missing items. A sensitivity analysis using multiple imputation was also carried out that included all participants who provided consent and were randomised, including those with missing SNOT-22 scor...
PMC10583133
Sample size calculation
The sample of 378 participants was based on 90% power to detect a minimal clinically important difference of 9 points on SNOT-22,
PMC10583133
Patient and public involvement
Patient and public involvement was integrated throughout the design and conduct of the trial. More than 20 patients were consulted about the primary outcome measure, with most favouring the items covered by SNOT-22 over NOSE scale questionnaire. Patients’ views were integrated into the design to encourage any crossover...
PMC10583133
Results
Nasal Obstruction
ADVERSE EVENTS, SECONDARY, RECRUITMENT
Between 26 January 2018 and 5 December 2019, 378 eligible participants (67% men) were randomised. Baseline personal characteristics were balanced across treatment groups (Baseline characteristics of recruited participants. Values are number (percentage) unless stated otherwiseIQR=interquartile range; NOSE Nasal Obstruc...
PMC10583133
Treatment received
Of the 378 participants randomised, 188 were assigned to receive septoplasty and 190 were assigned to receive medical management (Flow of participants through study
PMC10583133
Primary outcome analysis
Nasal Obstruction
Patient reported symptoms improved in both groups. In those participants randomised to receive septoplasty in the ITT population (n=152), mean SNOT-22 scores were 44.5 (95% confidence interval 41.1 to 47.8) at baseline and 19.9 (17.0 to 22.7) at six months. The corresponding scores for those participants randomised to ...
PMC10583133
Secondary outcomes
inferior turbinate reduction, Nasal Obstruction
SECONDARY
The improvement in SNOT-22 scores in the septoplasty group remained at 12 months but was less noticeable compared with those in the medical management group (Box plots showing summary statistics for SNOT-22 scores in intention-to-treat groups. Box represents middle 50% of data (lower quartile to upper quartile), horizo...
PMC10583133
Safety
ADVERSE EVENTS
Reported serious adverse events and adverse events among all participants
PMC10583133
Discussion
ear/facial pain, nasal obstruction, nasal airflow, nasal or sinus disease, inferior turbinate reduction
SECONDARY
Septoplasty results in significantly greater improvement in patient reported SNOT-22 scores at six months compared with a regimen of nasal steroid and saline sprays, and this improvement is sustained to 12 months. We therefore recommend that adults presenting with nasal obstruction associated with a deviated nasal sept...
PMC10583133
Limitations of this study
nasal valve dysfunction, rhinitis, Nasal obstruction, nasal obstruction
CHRONIC RHINOSINUSITIS, SECONDARY, RHINITIS, ALLERGIC RHINITIS
The study has several limitations. At baseline, more than 80% of patients had NOSE scores in the severe or extreme category. This may reflect the population currently referred to secondary care. However, the conclusions for these two subgroups were strong. The benefits for those participants with moderate baseline symp...
PMC10583133
Conclusions
nasal obstruction
Septoplasty is a superior treatment for nasal obstruction associated with septal deviation compared with a defined regimen of nasal steroid and saline sprays. Baseline NOSE scores can estimate the likely improvement in symptoms and guide decision making for patients and clinicians. The authors recommend that adults pre...
PMC10583133
What is already known on this topic
SECONDARY
In 2014, the UK National Institute for Health and Care Research commissioned a randomised controlled trial to address the lack of high quality evidence to support nasal septoplastyA study in 2019 reported higher levels of general quality of life at 12 months in participants after septoplasty compared with those who rec...
PMC10583133
What this study adds
Leigh, Paget, nasal obstruction
LEIGH, RECRUITMENT
Septoplasty is a clinically effective treatment for nasal obstruction associated with septal deviation compared with a defined regimen of nasal steroid and saline spraysParticipants who underwent septoplasty had greater improvement in nasal obstruction and quality of life, as measured using the SNOT-22 questionnaireHow...
PMC10583133
Ethics statements
PMC10583133
Ethical approval
The North East – Newcastle and North Tyneside 2 UK Health Research Authority Regional Ethics Committee (August 2017, study reference No 17/NE/0239).
PMC10583133
Data availability statement
The chief investigator and collaborators will act as custodians of the trial data and manage data sharing requests through ReShare, a UK online data repository recommended by the funder. Parties interested in data sharing will directly contact the chief investigator and collaborators and complete a project proforma and...
PMC10583133
Background
postoperative pain, pain
Management of acute postoperative pain is one of the major challenges in pediatric patients. Oral oxycodone has shown good pain relief in postoperative pain relief in children, but no studies have investigated intravenous oxycodone in this context.
PMC10155412
Objective
postoperative pain
whether oxycodone PCIA can provide adequate and safe postoperative pain relief, in comparison to tramadol as reference opioid drug.
PMC10155412
Design
a randomized, double-blind, parallel, multi-center clinical trial.
PMC10155412
Setting
five university medical centers and three teaching hospitals in China.
PMC10155412
Participants
patients aged 3-month-old to 6-year-old undergoing elective surgery under general anesthesia.
PMC10155412
Intervention
patients were randomly allocated to either tramadol (n = 109) or oxycodone (n = 89) as main postoperative opioid analgesic. Tramadol or oxycodone were administered with a loading dose at the end of surgery (1 or 0.1 mg.kg
PMC10155412
Outcomes
postoperative pain, consolability
the primary outcome was adequate postoperative pain relief, defined as a face, legs, activity, cry, and consolability (FLACC) score < 4/10 in the post-anesthesia care unit (PACU), with no need for an alternative rescue analgesia. FLACC was measured 10 min after extubation then every 10 min until discharge from PACU. An...
PMC10155412
Results
postoperative pain, nausea and vomiting
tramadol and oxycodone provided a similar level of adequate postoperative pain relief in PACU and in the wards. No significant differences were either noted for the raw FLACC scores, the bolus dose demand in PACU, the time between the first bolus dose and discharge from PACU, analgesic drug consumption, bolus times req...
PMC10155412
Conclusions
postoperative pain
an adequate postoperative analgesia can be achieved with intravenous oxycodone, this with less side effects than tramadol. It can therefore be a choice for postoperative pain relief in pediatric patients.
PMC10155412
Trial registration
The study was registered at
PMC10155412
Key points
postoperative pain, pain
Question: Can the intravenous administration of oxycodone provide adequate postoperative analgesia in children?Findings: Oxycodone can provide well postoperative pain control in children, similar to tramadol.Meanings: For the first time, we demonstrate that administration of oxycodone intravenously can provide well acu...
PMC10155412
Keywords
PMC10155412
Background
postoperative pain, nausea and vomiting
Acute postoperative pain is one of the major challenges for the anesthesiologists [Compared to adults, children should receive analgesia through the most comfortable and least painful method available. The oral administration of analgesics is straightforward and has demonstrated good effectiveness in various settings. ...
PMC10155412
Materials and methods
PMC10155412
Study design
This is a randomized, double-blind, parallel, multi-center clinical trial. This study was approved by the medical ethics committee, the second affiliated hospital of Xi’an Jiaotong University (2018024), and written informed consent was approved by each patient’s legal guardian. The study was registered at
PMC10155412
Patients
Patients [3-month-old to 6-year-old, Body Mass Index (BMI) 18-29.5 kg/m
PMC10155412
Randomization and blinding
BLIND
A biostatistician who is unaware of treatments and patient follow-up, generates the random numbers using the SAS software (SAS Institute, USA) in a ratio of 1:1, named group A and group B. The randomization sequence is stored online until the end of the study (Only the biostatistician was aware of the randomization seq...
PMC10155412
Procedures
postoperative pain, consolability, Pain, pain
Patients were fasting from clear liquids for 4 h and solid food for 6 h prior to undergoing anesthesia. No analgesic or antiemetic drugs were administrated before the procedure. Thirty minutes before the procedure, patients received an intramuscular administration of 0.01 mg.kgCisatracurium infusion was discontinued 30...
PMC10155412
Outcomes
hypoxemia, postoperative pain
ADVERSE EVENTS, SECONDARY, BLIND
Outcome assessment was performed by researchers who were kept blind to the patient’s group assignments. The primary outcome was whether oxycodone could provide adequate postoperative pain relief after surgery in pediatric patients. The definition of adequate postoperative pain relief includes (1) the FLACC score< 4 in ...
PMC10155412
Statistical analysis
A pilot observational study in our center showed that the FLACC scores between the oxycodone and tramadol groups in PACU were 3.71 ± 1.71 and 4.49 ± 1.74, respectively. The sample size required was 166 patients (83 patients in each group) after calculation with two-tailed α = 0.05 and β = 0.2 using the SAS software (SA...
PMC10155412
Results
postoperative pain, pruritus, CRF, nausea & vomiting
ADVERSE EVENTS, CRF
From October 2018 to September 2019, 240 patients were screened and 21 of them were excluded (Fig.  Trial profile. Data analysis included all patients in the groups to which they were randomly assigned. CRF: case report formWe did not find any significant difference in the demographic data between oxycodone and tramado...
PMC10155412
Discussion
PONV, postoperative pain, nausea and vomiting, pain
ADVERSE EFFECTS, ADVERSE EFFECT
There are several reasons for the cautious use of opioids in pediatric postoperative pain management, one of which is the fear of potential severe adverse effects due to children’s young age and small size. Although oral oxycodone has been widely used for pain relief in children, there is no literature on the use of in...
PMC10155412
Acknowledgements
We appreciated that Prof. Krister Nilsson from Sweden kindly gave a lot of help for manuscript revision.
PMC10155412
Authors’ contributions
Zhengchen Li
Dr. Siyuan Li contributes to study design, project administration, data analysis, study conduction, data collection & analysis, and manuscript preparation; Drs. Hongfei Xiong, Yingping Jia, Zhengchen Li, Yexi Chen, Liang Zhong, Feng Liu, Shuangquan Qu, Zhen Du, Yuxia Wang, Suxia Huang, Yonghui Zhao contributed to study...
PMC10155412