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Respiratory Medicine Oct 2023One of the major concerns with post-acute sequelae of COVID-19 (PASC) is the development of pulmonary fibrosis, for which no approved pharmacological treatment exists.... (Clinical Trial)
Clinical Trial
INTRODUCTION
One of the major concerns with post-acute sequelae of COVID-19 (PASC) is the development of pulmonary fibrosis, for which no approved pharmacological treatment exists. Therefore, the primary aim of this open-label study was to evaluate the safety and the potential clinical efficacy of a prolonged-release pirfenidone formulation (PR-PFD) in patients having PASC-pulmonary fibrosis.
METHODS
Patients with PASC-pulmonary fibrosis received PR-PFD 1800 mg/day (1200 mg in the morning after breakfast and 600 mg in the evening after dinner) for three months. Blood samples were taken to confirm the pharmacokinetics of PR-PFD, and adverse events (AEs) were evaluated monthly using a short questionnaire. Symptoms, dyspnea, and pulmonary function tests (spirometry, diffusing capacity for carbon monoxide, plethysmography, and 6-min walk test [6MWT]) were evaluated at baseline, and one and three months after having started the PR-PFD treatment.
RESULTS
Seventy subjects with mild to moderate lung restriction were included. The most common AEs were diarrhea (23%), heartburn (23%), and headache (16%), for which no modifications in the drug study were needed. Two patients died within the first 30 days of enrolment, and three opted not to continue the study, events which were not associate with PR-PFD. Pulmonary function testing, 6MWT, dyspnea, symptoms, and CT scan significantly improved after three months of treatment with PR-PFD.
CONCLUSION
In patients with PASC pulmonary fibrosis, three months' treatment with PR-PFD was safe and showed therapeutic efficacy. Still, it remains to be seen whether the pulmonary fibrotic process remains stable, becomes progressive or will improve.
Topics: Humans; COVID-19; Disease Progression; Dyspnea; Idiopathic Pulmonary Fibrosis; Phenotype; Pneumonia; Pyridones
PubMed: 37451648
DOI: 10.1016/j.rmed.2023.107362 -
Diabetes Care Sep 2023Meals are a consistent challenge to glycemic control in type 1 diabetes (T1D). Our objective was to assess the glycemic impact of meal anticipation within a fully... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Meals are a consistent challenge to glycemic control in type 1 diabetes (T1D). Our objective was to assess the glycemic impact of meal anticipation within a fully automated insulin delivery (AID) system among adults with T1D.
RESEARCH DESIGN AND METHODS
We report the results of a randomized crossover clinical trial comparing three modalities of AID systems: hybrid closed loop (HCL), full closed loop (FCL), and full closed loop with meal anticipation (FCL+). Modalities were tested during three supervised 24-h admissions, where breakfast, lunch, and dinner were consumed per participant's home schedule, at a fixed time, and with a 1.5-h delay, respectively. Primary outcome was the percent time in range 70-180 mg/dL (TIR) during the breakfast postprandial period for FCL+ versus FCL.
RESULTS
Thirty-five adults with T1D (age 44.5 ± 15.4 years; HbA1c 6.7 ± 0.9%; n = 23 women and n = 12 men) were randomly assigned. TIR for the 5-h period after breakfast was 75 ± 23%, 58 ± 21%, and 63 ± 19% for HCL, FCL, and FCL+, respectively, with no significant difference between FCL+ and FCL. For the 2 h before dinner, time below range (TBR) was similar for FCL and FCL+. For the 5-h period after dinner, TIR was similar for FCL+ and FCL (71 ± 34% vs. 72 ± 29%; P = 1.0), whereas TBR was reduced in FCL+ (median 0% [0-0%] vs. 0% [0-0.8%]; P = 0.03). Overall, 24-h control for HCL, FCL, and FCL+ was 86 ± 10%, 77 ± 11%, and 77 ± 12%, respectively.
CONCLUSIONS
Although postprandial control remained optimal with hybrid AID, both fully AID solutions offered overall TIR >70% with similar or lower exposure to hypoglycemia. Anticipation did not significantly improve postprandial control in AID systems but also did not increase hypoglycemic risk when meals were delayed.
Topics: Male; Humans; Adult; Female; Middle Aged; Insulin; Diabetes Mellitus, Type 1; Blood Glucose; Hypoglycemic Agents; Meals; Insulin, Regular, Human; Insulin Infusion Systems; Cross-Over Studies
PubMed: 37478323
DOI: 10.2337/dc23-0119 -
International Urology and Nephrology Dec 2023There are few reports on the relationship between skipping breakfast and chronic kidney disease (CKD). We examined the skipping breakfast-CKD relationship and the...
BACKGROUND/OBJECTIVES
There are few reports on the relationship between skipping breakfast and chronic kidney disease (CKD). We examined the skipping breakfast-CKD relationship and the mediation effects of metabolic diseases (obesity, hypertension, and diabetes) on this relationship.
SUBJECTS/METHODS
We analyzed the data of 21,138 participants aged ≥ 40 years from the Korea National Health and Nutrition Examination Survey 2013-2018. Skipping breakfast was defined as rarely eating breakfast over the past year. CKD was defined as decreased kidney function expressed by an estimated glomerular filtration rate of < 60 mL/min/1.73 m. We used a complex sample logistic regression model to examine the relationship between skipping breakfast and CKD. We used Baron and Kenny's approach to examine whether metabolic diseases work as a mediator within the skipping breakfast-CKD relationships.
RESULTS
About 7.6% of participants skipped breakfast, and 5.5% had CKD. After adjusting for confounders, participants who skipped breakfast were at higher odds of having CKD (odds ratio 1.61; 95% confidence interval 1.07-2.42; p value 0.021) compared to those who did not skip breakfast. With full adjustments for confounders, skipping breakfast was not significantly associated with any metabolic diseases, while CKD was significantly associated with diabetes and hypertension.
CONCLUSION
We found that middle-aged or older people who skipped breakfast had a significantly higher odds of having CKD compared to those who did not skip breakfast. However, metabolic diseases did not mediate the relationship between skipping breakfast and CKD.
Topics: Middle Aged; Humans; Aged; Breakfast; Feeding Behavior; Nutrition Surveys; Diabetes Mellitus; Metabolic Diseases; Hypertension; Renal Insufficiency, Chronic
PubMed: 37093440
DOI: 10.1007/s11255-023-03590-5 -
The American Journal of Clinical... May 2024The longitudinal association between specific eating behaviors, such as skipping breakfast and night eating, and changes in weight and waist circumference (WC) has been...
BACKGROUND
The longitudinal association between specific eating behaviors, such as skipping breakfast and night eating, and changes in weight and waist circumference (WC) has been understudied.
OBJECTIVES
The objective of this study was to investigate whether skipping breakfast and night eating were individually or jointly associated with the annual changes in weight and WC.
METHODS
In the current longitudinal study, included were 48,150 Chinese adults (mean age: 50.1 ± 13.9 y) who were free of diabetes, cardiovascular diseases, and cancer in 2014, when data on dietary intake and the presence of night-eating behavior and skipping breakfast were collected via questionnaires. Weight and WC were measured repeatedly in 2014, 2016, and 2018. The associations between night eating and/or skipping breakfast and annual changes in weight and WC were evaluated using the generalized estimating equation models, adjusting for age, sex, total energy, diet quality, and other potential confounders.
RESULTS
During 4-y of follow-up, among people who had both 2 unhealthy eating behaviors, the mean difference in annual weight change was 0.53 kg (95% confidence interval: 0.43, 0.63 kg) and 0.41 cm (95% confidence interval: 0.27, 0.55 cm) in annual WC change, compared with participants without either behavior. The associations of eating behaviors and change in weight and WC were more pronounced in participants with higher baseline body mass index (in kg/m) relative to their counterparts. Similarly, the associations between these eating behaviors and WC change were stronger in those with poorer diet quality relative to those with better diet quality.
CONCLUSIONS
Individuals with frequent skipping breakfast and/or night eating experienced faster gains in weight and WC, even after adjusting for diet quality and energy intake.
PubMed: 38802062
DOI: 10.1016/j.ajcnut.2024.05.021 -
Clinical Nutrition (Edinburgh, Scotland) Oct 2023Recent evidence suggests that the ability to regulate glucose and insulin homeostasis is different in men and women. Against this background, it has been hypothesized... (Randomized Controlled Trial)
Randomized Controlled Trial
The effects of Mediterranean diets with low or high glycemic index on plasma glucose and insulin profiles are different in adult men and women: Data from MEDGI-Carb randomized clinical trial.
BACKGROUND & AIMS
Recent evidence suggests that the ability to regulate glucose and insulin homeostasis is different in men and women. Against this background, it has been hypothesized that the impact on daily plasma glucose and insulin profiles of the glycemic index (GI) of the habitual diet may differ according to sex. The aim of this study is to evaluate whether 8-h average plasma glucose and insulin profiles during a low- or a high-GI diet in individuals at high risk of developing type 2 diabetes are influenced by sex.
METHODS
We conducted a randomized, controlled, parallel group dietary intervention, comparing high-versus low-GI diets in a multi-national (Italy, Sweden, and the United States) sample of 156 adults at risk for type 2 diabetes. For 12 weeks, 82 vs 74 participants consumed either a low-GI or high-GI Mediterranean diet, respectively. The two experimental diets contained the same quantity of available carbohydrate (270 g/d) and fiber (35 g/d) and the same foods and beverages, except for the major sources of starch that was specific to the low-GI and high-GI groups (pasta, brown rice, flatbread, all bran, and wheat bread plus rye and seeds, vs jasmine rice, potato, couscous, wholegrain bread, and rusks). At baseline and after the intervention plasma glucose and insulin profiles were evaluated for 8 h in the two intervention groups - separately for men and women - with both breakfast and lunch resembling food choices of the assigned diet.
RESULTS
One hundred fifty-six adults (82 women, 74 men) with at least two traits of the metabolic syndrome completed the intervention. In women, the high-GI induced significantly higher (23%, p < 0.05) 8-h average plasma glucose concentrations in comparison to the low-GI diet already on the first day of the intervention; the difference increased up to 37% (p < 0.05) after 12 weeks of diet. Conversely, there were no significant differences between the two diets in men. These results were confirmed by the two-way analysis of variance showing a statistically significant interaction between the effects of sex and diet on the glucose profile after breakfast and lunch (F = 7.887, p = 0.006).
CONCLUSION
The results of our intervention show that women, compared to men, are more sensitive to the metabolic effects of the dietary GI. This has a strong clinical and scientific relevance and, if confirmed in further studies, it might have important implications for dietary strategies for diabetes and cardiovascular disease prevention in the context of personalized nutrition.
REGISTRATION NUMBER OF CLINICAL TRIAL
Clinicaltrials.gov n. NCT03410719.
Topics: Male; Adult; Female; Humans; Insulin; Diet, Mediterranean; Blood Glucose; Diabetes Mellitus, Type 2; Glycemic Index; Bread; Glucose
PubMed: 37651979
DOI: 10.1016/j.clnu.2023.08.016 -
Trials Dec 2023Vonoprazan results in more potent acid suppression for gastroesophageal reflux disease (GERD) than proton pump inhibitors. It has only been approved for treating erosive...
Different dosages of vonoprazan for gastroesophageal reflux disease: study protocol for a pragmatic, crossover-cluster, randomized controlled trial with patient preference arms.
BACKGROUND
Vonoprazan results in more potent acid suppression for gastroesophageal reflux disease (GERD) than proton pump inhibitors. It has only been approved for treating erosive esophagitis in China, but 30-40% of GERD patients cannot achieve the goal of treatment with vonoprazan 20 mg daily. This study aims to investigate whether vonoprazan could relieve the symptoms of Chinese patients with non-erosive reflux disease (NERD) and whether increased dosage or different times of dosing could increase the response rate of GERD.
METHODS
This study is a pragmatic, open-label, crossover-cluster, randomized controlled trial with patient preference arms. Two thousand eight hundred eighty patients with GERD from 48 hospitals in China will be enrolled. These hospitals will be divided into a compulsory randomization cluster (24 hospitals) and a patient preference cluster (24 hospitals). Patients in the compulsory randomization cluster will be randomized to three regimens according to the crossover-cluster randomization. Patients in the patient preference cluster may choose to receive any regimen if they have a preference; otherwise, patients will be randomly assigned. The three treatment regimens will last 4 weeks, including (1) vonoprazan 20 mg p.o. after breakfast, (2) vonoprazan 20 mg p.o. after dinner, and (3) vonoprazan 20 mg p.o. after breakfast and after dinner. Patients will attend a baseline visit, a 4-week e-diary, a fourth-week visit, and a sixth-month visit online. The primary outcome is the symptom relief rate of all patients after 4-week therapy. Secondary outcomes include the healing rate of EE patients, the severity of symptoms, compliance with the therapy at the fourth-week follow-up visit, recurrent symptoms, and the frequency of self-conscious doctor visits at the sixth-month follow-up visit.
DISCUSSION
This trial will explore the effectiveness of different regimens of vonoprazan that will be implemented with GERD patients in China. The randomization with patient preferences considered and the crossover-cluster component may improve the robustness and extrapolation of study conclusions.
TRIAL REGISTRATION
https://www.chictr.org.cn ChiCTR2300069857. Registered on 28 March 2023.
PROTOCOL VERSION
February 18, 2023, Version 2.
Topics: Humans; Patient Preference; Gastroesophageal Reflux; Proton Pump Inhibitors; Pyrroles; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38041136
DOI: 10.1186/s13063-023-07760-9 -
Antioxidants (Basel, Switzerland) Jul 2023Vitamins, hormones, free radicals, and antioxidant substances significantly influence athletic performance. The aim of this study was to evaluate whether these...
Vitamins, hormones, free radicals, and antioxidant substances significantly influence athletic performance. The aim of this study was to evaluate whether these biological mediators changed during the season and if this was associated with the rate of improvement in performance after training, assessed by means of a standardized test. Professional male soccer players took part in the study. Two evaluations were performed: the first in the pre-season period and the second at the mid-point of the official season, after about 6 months of intensive training and weekly matches. Blood levels of vitamins D, B12, and folic acid, testosterone and cortisol, free radicals, and antioxidant substances were measured. Two hours after breakfast, a Yo-Yo test was performed. The relationships between the biological mediators and the rate of improvement after training (i.e., the increase in meters run in the Yo-Yo test between the pre-season and mid-season periods) were evaluated by means of a linear mixed models analysis. Results: Eighty-two paired tests were performed. The athletes showed better performance after training, with an increase in the meters run of about 20%. No significant relationships between the vitamin and hormone values and the gain in the performance test were observed. Plasmatic levels of free radicals increased significantly, as did the blood antioxidant potential. An indirect relationship between oxidative stress and the improvement in performance was observed (free radicals β ± SE: = -0.33 ± 0.10; -value = 0.001), with lower levels of oxidative stress being associated with higher levels of performance in the Yo-Yo test. Monitoring the measures of oxidative stress could be a useful additional tool for coaches in training and/or recovery programs tailored to each player.
PubMed: 37508008
DOI: 10.3390/antiox12071470 -
Chinese Medical Journal Oct 2023Although the treatment of peripheral T-cell lymphoma (PTCL) has undergone advancements during the past several years, the response rate and long-term effects with...
BACKGROUND
Although the treatment of peripheral T-cell lymphoma (PTCL) has undergone advancements during the past several years, the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory-particularly for relapsed or refractory (R/R) patients. This phase II trial was designed to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone, cyclophosphamide, and thalidomide (CPCT) for R/R PTCL patients who could not tolerate the standard chemotherapy for a variety of reasons.
METHODS
We conducted a multicenter phase II clinical trial in which we combined chidamide (30 mg twice weekly) with prednisone (20 mg daily after breakfast), cyclophosphamide (50 mg daily after lunch), and thalidomide (100 mg daily at bedtime) (the CPCT regimen) for a total of fewer than 12 cycles as an induction-combined treatment period, and then applied chidamide as single-drug maintenance. Forty-five patients were ultimately enrolled from August 2016 to April 2021 with respect to Chinese patients at nine centers. Our primary objective was to assess the overall response rate (ORR) after the treatment with CPCT.
RESULTS
Of the 45 enrolled patients, the optimal ORR and complete response (CR)/CR unconfirmed (CRu) were 71.1% (32/45) and 28.9% (13/45), respectively, and after a median follow-up period of 56 months, the median progression-free survival (PFS) and overall survival (OS) were 8.5 months and 17.2 months, respectively. The five-year PFS and OS rates were 21.2% (95% confidence interval [CI], 7.9-34.5 %) and 43.8% (95% CI, 28.3-59.3 %), respectively. The most common adverse event was neutropenia (20/45, 44.4%), but we observed no treatment-related death.
CONCLUSION
The all-oral CPCT regimen was an effective and safety regimen for R/R PTCL patients who could not tolerate standard chemotherapy for various reasons.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02879526.
PubMed: 37839894
DOI: 10.1097/CM9.0000000000002836 -
Chronobiology International Sep 2023Ageing is associated with a decline in circadian clock systems, which correlates with the development of ageing-associated diseases. Chrononutrition is a field of...
Ageing is associated with a decline in circadian clock systems, which correlates with the development of ageing-associated diseases. Chrononutrition is a field of chronobiology that examines the relationship between the timing of meal/nutrition and circadian clock systems. Although there is growing evidence regarding the role of chrononutrition in the prevention of lifestyle and ageing-related diseases, the optimal timing of meal intake to regulate the circadian clock in humans remains unknown. In this study, we investigated the relationship between clock gene expression and meal timing in young and older adults. In this cross-sectional study, we enrolled 51 healthy young men and 35 healthy older men (age, mean±standard deviation: 24 ± 4 and 70 ± 4 y, respectively). Under daily living conditions, beard follicle cells were collected at 4-h intervals over a 24-h period to evaluate clock gene expression. Participants were asked to record the timing of habitual sleep and wake-up, breakfast, lunch, and dinner. From these data, we calculated "From bedtime to breakfast time," "From wake up to first meal time," and "From dinner to bed time." and expressions in older adults at 06:00 h were significantly higher than those in young adults ( = 0.001). There were significant differences in the peak time for ( = 0.003) and ( = 0.049) expression between young and older adults. "From bedtime to breakfast time" was significantly longer in older adults than in young adults. In contrast, "From dinner to bed time" was significantly shorter in older adults than in young adults. Moreover, higher rhythmicity of correlated with longer "From bedtime to breakfast time" ( = -0.470, = 0.002) and shorter "From wake up to first meal time" in young adults ( = 0.302, = 0.032). Higher rhythmicity of correlated with longer "From bedtime to breakfast time" in older adults ( = -0.342, = 0.045). These results suggest that the peak time of clock gene expression in older adults may be phase-advanced compared to that in young adults. In addition, a longer fasting duration from bedtime to breakfast in both young and older adults and earlier intake of meals after waking up in young adults may correlate with robust clock gene expression rhythms.
PubMed: 37722714
DOI: 10.1080/07420528.2023.2256855 -
Chronobiology International Jun 2024Breakfast skipping and late-evening snack are prevalent in young adults. This randomized controlled intervention aimed to evaluate the influence of meal habit...
Breakfast skipping and late-evening snack are prevalent in young adults. This randomized controlled intervention aimed to evaluate the influence of meal habit recommendations on young adults' body composition and blood pressure. Nonpregnant adults (≥20 y old) who were eligible for bioelectrical impedance analysis examination (neither pacemaker installed nor medications that would affect body composition, like diuretics or corticosteroids) were enrolled after they provided informed consent ( = 125). Subjects were randomized into three groups, every group receiving one of the following recommendations: (a) daily breakfast consumption (within 2 h after waking up), (b) avoidance of late-evening snacks (after 21:00h or within 4 h before sleep, with the exception of water), and (c) both recommendations. Body composition and blood pressure were measured before randomization at baseline and at the follow-up 1 y later. Intent-to-treat analysis showed that the recommendation of daily breakfast may contribute to a lower increment of diastolic blood pressure by 3.23 mmHg (95% CI: 0.17-6.28). Receiving the breakfast recommendation was associated with more reduction of total body fat percent by 2.99% (95% CI: 0.23-5.74) and percent trunk fat by 3.63% (95% CI: 0.40-6.86) in inactive youths. Recommendation of avoiding late-evening snack did not significantly affect the outcome measures (ClinicalTrials.gov Identifier: NCT03828812).
PubMed: 38860554
DOI: 10.1080/07420528.2024.2363492