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Frontiers in Endocrinology 2023We aimed to evaluated the effect of premixed insulin (Ins), premixed insulin combined with metformin (Ins+Met) or mulberry twig alkaloids(Ins+SZ-A) on blood glucose... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of mulberry twig alkaloids(Sangzhi alkaloids) and metformin on blood glucose fluctuations in combination with premixed insulin-treated patients with type 2 diabetes.
INTRODUCTION
We aimed to evaluated the effect of premixed insulin (Ins), premixed insulin combined with metformin (Ins+Met) or mulberry twig alkaloids(Ins+SZ-A) on blood glucose fluctuations in patients with type 2 diabetes (T2DM) using continuous glucose monitors (CGM).
METHODS
Thirty patients with T2DM and poor blood glucose control using drugs were evaluated for eligibility during the screening period. Subsequently, their original hypoglycemic drugs were discontinued during the lead-in period, and after receiving Ins intensive treatment for 2 weeks, they were randomly assigned to receive either Ins, Ins+Met, or Ins+SZ-A treatment for the following 12 weeks. The main efficacy endpoint comprised changes in their CGM indicators changes (mean blood glucose level [MBG], standard deviation of blood glucose [SDBG], mean amplitude of glycemic excursions [MAGE], postprandial glucose excursions [PPGE], the largest amplitude of glycemic excursions [LAGE], mean of daily difference [MODD], time in range between 3.9-10.0 mmol/L [TIR] and area under the curve for each meal [AUCpp]) during the screening, lead-in, and after 12-week treatment period. Changes in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), 1-h postprandial blood glucose (1h-PBG), 2-h postprandial blood glucose (2h-PBG), fasting blood lipids and postprandial blood lipids were also measured at baseline and after 12 weeks of treatment.
RESULTS
The CGM indicators of the three groups during the lead-in period all showed significant improvements compared to the screening period (P<0.05). Compared with those in the lead-in period, all of the CGM indicators improved in the the Ins+Met and Ins+SZ-A groups after 12 weeks of treatment (P<0.05), except for MODD. After 12-week treatment, compared with the Ins group, Ins+Met and Ins+SZ-A groups showed improved MBG, SDBG, TIR, breakfast AUCpp,lunch AUCpp, HbA1c, FBG, 1h-PBG, fasting blood lipid and postprandial blood lipid indicators (P<0.05). Further, the LAGE, PPGE, MAGE, dinner AUCpp and 2h-PBG levels of the Ins+SZ-A group were significantly lower than those of the Ins+Met and Ins groups (P<0.05).
CONCLUSION
Our findings highlight the efficacy of combination therapy (Ins+SZ-A or Ins+Met) in improving blood glucose fluctuations, as well as blood glucose and lipid levels. Ins+SZ-A reduces postprandial blood glucose fluctuations more than Ins+Met and Ins groups.
TRIAL REGISTRATION NUMBER
ISRCTN20835488.
Topics: Humans; Blood Glucose; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Insulin; Lipids; Metformin; Morus
PubMed: 38027146
DOI: 10.3389/fendo.2023.1272112 -
Journal of Asthma and Allergy 2023Fruits have been identified as the primary triggers of anaphylaxis in older children in the Chinese population, especially among individuals with pollen sensitization....
PURPOSE
Fruits have been identified as the primary triggers of anaphylaxis in older children in the Chinese population, especially among individuals with pollen sensitization. To date, no allergies have been reported after blueberry ingestion in the Chinese population.
CASE REPORT
A 12-year-old girl experienced one episode of anaphylaxis within 30 minutes of having breakfast (including milk, egg, wheat bread, and blueberry) while walking to school. She menstruated during this episode. Prompt treatment with epinephrine and fluid therapy led to full recovery within 24 h. Specific IgE was conducted using ImmunoCAP, and the patient exhibited sensitization to several pollens, mainly Japanese hop (74.3 kUa/L) and mugwort (26.5 kUa/L). Regarding specific IgE to allergen components, the patient showed sensitization primarily to lipid transfer protein (LTP) components from mugwort Art v 3 (79.7 kUa/L), wheat Tri a 14 (12.4 kUa/L) and peach Pru p 3 (2.15 kUa/L), but tested negative for omega-5 gliadin. The prick test results were positive for blueberries (wheal size 9.5 mm), cherries (wheal size 6.5 mm), kiwifruits (wheal size 6 mm), and pears (wheal size 4.5 mm). Our patient was provided with an epi-pen and was advised to avoid consuming relevant fruits. After four months of follow-up, the patient had not experienced any episodes of anaphylaxis since these recommendations were implemented.
CONCLUSION
We report for the first time a Chinese child with severe IgE-mediated immediate-type anaphylactic reaction to blueberries, in whom we identified LTP as the suspected allergen component.
PubMed: 38022748
DOI: 10.2147/JAA.S436561 -
CNS Drugs Dec 2023The transient receptor potential canonical (TRPC) ion channels have been implicated in the pathophysiology of major depressive disorder (MDD), and TRPC inhibition has... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of Single and Multiple Ascending Doses of BI 1358894 in Healthy Male Volunteers on Safety, Tolerability and Pharmacokinetics: Two Phase I Partially Randomised Studies.
INTRODUCTION
The transient receptor potential canonical (TRPC) ion channels have been implicated in the pathophysiology of major depressive disorder (MDD), and TRPC inhibition has been shown to reduce depressive-like behaviour in rodent models of depression. BI 1358894, a small-molecule inhibitor of TRPC ion channels, is currently being developed for the treatment of MDD.
OBJECTIVE
Two phase I studies assessed the safety, tolerability, and pharmacokinetics (PK) of oral BI 1358894 in fed and fasted states following a single ascending dose (SAD) [NCT03210272/1402-0001] and multiple ascending doses (MAD) [NCT03754959/1402-0002] in healthy male volunteers. In addition, any potential food effect was evaluated after a single dose.
METHODS
In both studies, eligible healthy male volunteers (aged 18-45 years; body mass index of 18.5-29.9 kg/m) were allocated to receive BI 1358894 or placebo. In the SAD study (1402-0001), volunteers were randomised 3:1 to receive BI 1358894 or placebo in fasted (3, 6, 10, 25, 50, 100, or 200 mg) and fed states (200 mg). The food effect part was conducted as an open-label, randomised, two-way crossover study at doses of 50 and 100 mg in fasted and fed states (high-calorie, high-fat breakfast). For the MAD study (1402-0002), volunteers were randomised 4:1 to receive BI 1358894 (10, 25, 50, 100, or 200 mg) or placebo once daily for 14 days under fed conditions. Primary endpoint (both studies): number of volunteers with drug-related adverse events (DRAEs). Secondary PK endpoints for study 1402-0001: area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC), maximum plasma concentration (C), and AUC from time zero to the last quantifiable data time point (AUC). Secondary PK endpoints for study 1402-0002: AUC over 0-24 h (AUC), C after the first dose, and steady-state AUC and C over a uniform dosing interval (AUC and C, respectively) after the last dose.
RESULTS
BI 1358894 was well tolerated at doses ≤ 200 mg under all tested conditions and no dose dependency was observed in DRAE frequency for either study. In the SAD study, BI 1358894 exposure increased dose proportionally across 3-50 mg in the fasted state and across 50-200 mg in the fed state. A positive food effect was observed at the tested doses. In the MAD study, BI 1358894 exposure increased less than dose proportionally across 10-200 mg.
CONCLUSIONS
These studies demonstrate that BI 1358894 is well tolerated in healthy male volunteers following single and multiple doses, with no dose dependency observed in DRAE frequency. BI 1358894 exposure increased dose dependently in both the SAD and MAD studies, with higher exposure of BI 1358894 observed in the fed state.
CLINICALTRIALS REGISTRATION
These trials have been registered on ClinicalTrials.gov: NCT03210272/1402-0001 (registered on 6 July 2017) and NCT03754959/1402-0002 (registered on 27 November 2018).
Topics: Humans; Male; Administration, Oral; Area Under Curve; Cross-Over Studies; Depressive Disorder, Major; Dose-Response Relationship, Drug; Double-Blind Method; Healthy Volunteers; Ion Channels
PubMed: 38019355
DOI: 10.1007/s40263-023-01041-4 -
Scientific Reports Nov 2023Vigorous intermittent exercise can improve indices of glycemia in the 24 h postexercise period in apparently healthy individuals. We examined the effect of a single... (Randomized Controlled Trial)
Randomized Controlled Trial
Vigorous intermittent exercise can improve indices of glycemia in the 24 h postexercise period in apparently healthy individuals. We examined the effect of a single session of bodyweight exercise (BWE) on glycemic responses using continuous glucose monitoring (CGM) under controlled dietary conditions. Healthy inactive adults (n = 27; 8 males, 19 females; age: 23 ± 3 years) completed 2 virtually supervised trials spaced ~ 1 week apart in a randomized, crossover manner. The trials involved an 11-min BWE protocol that consisted of 5 × 1-min bouts performed at a self-selected pace interspersed with 1-min active recovery periods or a non-exercise sitting control period (CON). Mean heart rate during the BWE protocol was 147 ± 14 beats per min (75% of age-predicted maximum). Mean 24 h glucose after BWE and CON was not different (5.0 ± 0.4 vs 5.0 ± 0.5 mM respectively; p = 0.39). There were also no differences between conditions for measures of glycemic variability or the postprandial glucose responses after ingestion of a 75 g glucose drink or lunch, dinner, and breakfast meals. This study demonstrates the feasibility of conducting a remotely supervised BWE intervention using CGM under free-living conditions. Future studies should investigate the effect of repeated sessions of BWE training or responses in people with impaired glycemic control.
Topics: Male; Female; Humans; Adult; Young Adult; Blood Glucose; Cross-Over Studies; Blood Glucose Self-Monitoring; Exercise; Diet; Body Weight; Postprandial Period
PubMed: 38017140
DOI: 10.1038/s41598-023-48063-y -
Diabetology & Metabolic Syndrome Nov 2023Most studies initiated basal-bolus insulin in a ratio of 1:1 and titrated based on glucose. This study aimed to investigate the effectiveness and safety of a...
Efficacy and safety of basal-bolus insulin at 1:1.5 ratio compared to 1:1 ratio using a weight-based initiation and titration (WIT2) algorithm in hospitalized patients with type 2 Diabetes: a multicenter, randomized, clinical study.
BACKGROUND
Most studies initiated basal-bolus insulin in a ratio of 1:1 and titrated based on glucose. This study aimed to investigate the effectiveness and safety of a weight-based and ratio of 1:1.5 basal-bolus insulin using an algorithm for both initiation and titration in hospitalized patients with type 2 diabetes (T2D).
METHODS
Hospitalized patients with T2D were randomly assigned to two groups in equal numbers to receive 1:1.5 and 1:1 ratios of basal-bolus insulin using a weight-based algorithm for both initiation and titration. The primary outcome was the time taken to reach the fasting blood glucose (FBG) target and 2-h postprandial blood glucose (2hBG) targets after three meals. The secondary outcome included insulin dosage to achieve glycemic control and the incidence of hypoglycemia during hospitalization.
RESULTS
250 patients were screened between October 2021 and June 2022, 220 were randomly grouped, and 182 completed the trial (89 in the 1:1.5 and 93 in the 1:1 groups). The time taken to reach FBG targets was comparable between the two groups (3.4 ± 1.7 vs. 3.0 ± 1.3 days, p = 0.137) within about 3 days. The 2hBG after three meals was shorter in the 1:1.5 group than in the 1:1group (2.9 ± 1.5 vs. 3.4 ± 1.4 days, p = 0.015 for breakfast, 3.0 ± 1.6 vs. 3.6 ± 1.4 days, p = 0.005 for lunch, and 3.1 ± 2.1 vs. 4.0 ± 1.5 days, p = 0.002 for dinner). No significant difference in insulin dosages was found between the two groups at the end of the study. The incidence of hypoglycemia was similar in both groups.
CONCLUSIONS
We demonstrated that fixed dose-ratio basal-bolus insulin at 1:1.5 calculated using a weight-based initiation and titration algorithm was simple, as effective, and safe as ratio at 1:1 in managing T2D in hospitalized patients. Trial Registration ChiCTR 2,100,050,963. Date of registration: September 8, 2021.
PubMed: 38008775
DOI: 10.1186/s13098-023-01193-9 -
European Journal of Nutrition Feb 2024Unfavorable changes in eating patterns over time may contribute to upward trends in chronic diseases, such as obesity. We examined 20-year trends in the percentage of...
PURPOSE
Unfavorable changes in eating patterns over time may contribute to upward trends in chronic diseases, such as obesity. We examined 20-year trends in the percentage of energy from main meals and snacks and the food sources of each eating occasion among Korean adults.
METHODS
This study used nationally representative data from the 1st, 4th, and 7th Korea National Health and Nutrition Examination Surveys (1998, 2007-2009, and 2016-2018) among adults aged 20-69 years (n = 29,389). Each eating occasion (breakfast, lunch, dinner, and snacks) was defined by respondents during a 24-h dietary recall interview. To identify the food sources of each eating occasion, we used the NOVA system. The percentage of energy at each eating occasion and that from each NOVA group across survey cycles were estimated, and tests for linear trends were conducted using orthogonal polynomial contrasts in linear regression models. All analyses accounted for the complex survey design.
RESULTS
After adjusting for age and sex, the percentage of energy from breakfast decreased from 25.0% in 1998 to 16.7% in 2018 (difference, - 8.2%; standard error [SE], 0.3), whereas that from dinner and snacks increased from 31.1 to 33.8% (difference, + 2.7%; SE, 0.4) and from 14.0 to 19.0% (difference, + 5.0%; SE, 0.5), respectively (all P < 0.001). At all eating occasions, the percentage of energy from minimally processed foods declined (difference, - 18.6% for breakfast; - 13.1% for lunch; - 21.1% for dinner; - 20.7% for snacks), while that from ultra-processed foods increased (difference, + 17.0% for breakfast; + 11.3% for lunch; + 18.0% for dinner; + 30.7% for snacks). When stratified by age, the given trends were shown to a greater extent in younger adults (< 50 years old) than in older adults (≥ 50 years old).
CONCLUSIONS
The eating patterns of Korean adults changed from 1998 to 2018, with the greatest decrease in energy intake from breakfast and the greatest increase from snacking. At all eating occasions, the contribution of minimally processed foods declined, while that of ultra-processed foods increased, especially among younger adults.
Topics: Humans; Aged; Middle Aged; Snacks; Food, Processed; Meals; Diet; Energy Intake; Nutrition Surveys; Feeding Behavior; Republic of Korea; Eating
PubMed: 37999737
DOI: 10.1007/s00394-023-03258-x -
Geriatrics (Basel, Switzerland) Oct 2023Physical performance shows approximately 30% diurnal variation; however, diurnal variation in oral function remains unclear. This study aimed to determine the diurnal...
Physical performance shows approximately 30% diurnal variation; however, diurnal variation in oral function remains unclear. This study aimed to determine the diurnal variation in oral and swallowing function in older adults requiring long-term care. The participants included 13 adults aged >60 years (3 men and 10 women, mean age: 77.2 ± 6.3 years, age range: 62-90 years) requiring long-term care. Tongue strength (TS) and oral mucosal moisture were measured as indices of oral and swallowing function, while hand grip strength was measured as an index of general muscle strength. The patients were asked to participate in a "test" after breakfast, lunch, and dinner on the same day. Multilevel linear regression analysis was used to examine diurnal differences in each item. Multilevel linear regression analysis with adjustment for age and sex revealed that TS was significantly higher at noon ( = 0.001) than in the morning. Therefore, caregivers who provide support during meals to older people requiring long-term care should consider the possibility of swallowing function differing according to the time of the day. In conclusion, it may be beneficial to establish a nutritional therapy that accounts for the diurnal variation in TS.
PubMed: 37987467
DOI: 10.3390/geriatrics8060107 -
Journal of Global Health Nov 2023Suboptimal health status (SHS) is a non-clinical or pre-disease state between optimal/ideal health and disease. While its etiology remains unclear, lifestyle is...
BACKGROUND
Suboptimal health status (SHS) is a non-clinical or pre-disease state between optimal/ideal health and disease. While its etiology remains unclear, lifestyle is considered one of the most important risk factors. We aimed to examine the effects of lifestyles on SHS through a nationwide survey in China.
METHODS
We conducted a cross-sectional survey in 148 cities across China between 20 June and 31 August 2022, on 30 505 participants from rural and urban communities gathered through stratified quota sampling. We measured SHS with the Short-Form Suboptimal Health Status Questionnaire (SHSQ-SF). We gathered information on participants' lifestyles (ie, smoking, alcohol consumption, breakfast habits, weekly food delivery frequency, intermittent fasting, sleep duration and physical activities) through face-to-face interview. We determined the relationship between lifestyle and SHS logistic regression analysis by based on odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS
We included 22 897 participants (female: 13 056, male: 9841), 12 108 (52.88%) of whom reported exposure to SHS. After adjusting for demographic characteristics, individuals who currently smoked (OR = 1.165; 95% CI = 1.058-1.283) and those who drank alcohol (OR = 1.483; 95% CI = 1.377.1.596) were at a higher risk of SHS than those who have never done either. In a dose-response way, takeaway food consumption was associated with a higher risk of SHS, while increased frequency of breakfast and mild-intensity exercise conversely reduced said risk. Individuals with shorter sleep duration had a higher risk of SHS when compared to those who slept for more than seven hours per day.
CONCLUSIONS
We observed a relatively high prevalence of SHS across China, highlighting the importance of lifestyle in health promotion. Specifically, adopting healthy dietary habits, engaging in regular physical activity, and ensuring high-quality sleep are key in preventing SHS.
REGISTRATION
Chinese Clinical Trial Registry (ChiCTR2200061046).
Topics: Humans; Male; Female; Cross-Sectional Studies; Life Style; Health Promotion; Health Status; China
PubMed: 37974435
DOI: 10.7189/jogh.13.04151 -
Nutrients Oct 2023Dietary habits, including meal frequency, meal timing, and skipping meals, have been extensively studied due to their association with the development of noncommunicable...
Dietary habits, including meal frequency, meal timing, and skipping meals, have been extensively studied due to their association with the development of noncommunicable diseases (NCDs). This study describes dietary habits, meal timing, frequency, skipping meals, and late-night eating in Kuwaiti adults. Kuwait National Nutrition Surveillance System data were utilized to reach the objectives of this study. The findings reveal that approximately 54% of the adults in Kuwait eat after 10 p.m., 29% skip breakfast, and 9.8% skip dinner. Furthermore, adults in Kuwait consume 4.4 meals per day on average. Women skip breakfast more often and have more extended night fasting than men ( < 0.001). Married adults skip breakfast and dinner less than unmarried adults ( < 0.001). In conclusion, this descriptive study provides valuable insights into the dietary habits of Kuwaiti adults, emphasizing the importance of further investigating the association between meal timing, meal frequency, and the prevalence of NCDs in Kuwait.
Topics: Male; Humans; Adult; Female; Kuwait; Meals; Feeding Behavior; Breakfast; Fasting
PubMed: 37960190
DOI: 10.3390/nu15214537 -
Journal of Dairy Science May 2024Share tables (ST) are tables or stations in school cafeterias where students can return unopened foods and beverages, providing an opportunity to access these items at...
Share tables (ST) are tables or stations in school cafeterias where students can return unopened foods and beverages, providing an opportunity to access these items at no cost. Currently, research suggests that milk is among the most wasted items in breakfast and lunch programs in the United States. Share tables present a simple solution for reducing milk waste, but research is needed to understand the microbial spoilage potential of milk in ST. To this end, uninoculated milk cartons and milk cartons inoculated with 2 to 3 log(cfu/mL) Pseudomonas poae, a fast-growing psychrotroph, was exposed to ambient temperature during winter (mean temperature = 20.3°C) and summer (23.1°C) for 125 min, repeated over 5 d (the length of a school week). Microbial counts in the inoculated milk cartons increased linearly, exceeding the spoilage threshold of 6.0 log(cfu/mL) after d 3 and after d 4 in the winter and summer season trials, respectively. In the winter trial, the microbial counts for uninoculated milk cartons never exceeded the lower limit of detection, 2.31 log(cfu/mL), and in the summer trials, microbial counts never reached the spoilage threshold, indicating that initial contamination is a driving factor of microbial milk spoilage. Regardless of sharing status or seasonality, the greatest changes in counts for inoculated milk cartons occurred during overnight refrigeration, ranging from 0.56 to 1.4 log(cfu/mL), while during the share table ranged from no observable change up to 0.29 log(cfu/mL), emphasizing that school nutrition personnel should focus efforts on tightly controlling refrigeration temperatures and returning milk to refrigeration as soon as possible. A previously developed model for school cafeteria share tables was adapted to understand the typical residence time of milk in a simulated cafeteria with an ambient temperature share table for the summer and winter seasons over 1,000 wk. Milk was predicted to have a very short mean residence time (85 min) regardless of sharing status or season, with 99.8% of milk consumed, discarded, or donated within the first 2 d. As a result, only 3 out of 451,410 and 6 out of 451,410 simulated milks spoiled in the winter and summer seasons, respectively. The data generated here can be used to inform science-based decision-making for including milk in share tables, or applied to any system where one might have to accept short-term unrefrigerated storage of milk to meet a waste reduction or food security goal.
Topics: Humans; Animals; Milk; Temperature; Food Microbiology; Colony Count, Microbial; Schools
PubMed: 37949407
DOI: 10.3168/jds.2023-24175