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Keywords | PMC10850008 | |||
Introduction | DISEASE, TYPE 2 DIABETES, COMPLICATIONS | Given the natural history of type 2 diabetes and the progressive decline in beta-cell function, most patients with the disease will undergo treatment intensification with the aim of preventing or delaying long-term complications [Simplification reduces the number of insulin injections and adapts the treatment strategy ... | PMC10850008 | |
Materials and methods | PMC10850008 | |||
Study design | hyperglycemia, diabetes | HYPERGLYCEMIA, RECRUITMENT, TYPE 2 DIABETES, DIABETES | The three-arm trial design of BEYOND has been described previously [BEYOND was a 6-month, randomized, pragmatic, parallel group, single-center trial that evaluated the efficacy and safety of either FRC or basal insulin plus SGLT-2i to replace a full basal-bolus insulin regimen in participants with type 2 diabetes exper... | PMC10850008 |
Outcomes | HYPOGLYCEMIA | The primary efficacy outcome of the extension trial was change from baseline in HbA1c at 24 months. Secondary outcomes were the proportion of participants with HbA1c < 7.0% (53 mmol/mol) or <7.5% (58 mmol/mol), total daily insulin doses, number of daily injections, percentage of participants with hypoglycemia, changes ... | PMC10850008 | |
Statistical analysis | SECONDARY | The efficacy population consisted of all participants randomized to study treatment (intention-to-treat). A per-protocol analysis was also performed. Categorical variables are expressed as frequencies and proportions; continuous variables are given as mean ± SD (variables normally distributed) or median and interquarti... | PMC10850008 | |
Results | PMC10850008 | |||
Baseline characteristics | glifo-combo | At the start of the extension study, the original 101 participants remained in the basal-bolus group, 90 participants were in the FRC group and 93 in the gliflo-combo group. At 24 months, there were additional 32 dropouts in the FRC group and 39 in the glifo-combo group (Fig. The trial has been completed in 24 months. ... | PMC10850008 | |
Adverse events | HYPOGLYCEMIA, EVENT, ADVERSE EVENTS, ACUTE PANCREATITIS | The proportion of patients presenting at least one episode of level 1hypoglycemia was 24.8%, 12.8%, and 9.9% in the basal-bolus, FRC, and gliflo-combo groups, respectively, with a significant difference among them (There was no event of acute pancreatitis in the fixed-combo group. Five participants in the FCR group and... | PMC10850008 | |
Acknowledgements | Di Lorenzo, Claudia | METABOLIC DISEASES | The authors thank Lucia Digitale Selvaggio, Francesco di Maio, Michela Di Nuzzo, Daniela Forestiere, Rita Matrone, Chiara Porcellini, Alessandra Volatile (Division of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy), Si... | PMC10850008 |
Author contributions | D.G., M.L., M.I.M., and K.E. designed the research. D.G., M.L., L.S., P.C., M.G., M.P., G.B., M.I.M., and K.E. conducted the research. M.L., P.C., and L.S. collected data in the electronic database. D.G., M.L., and M.I.M. performed statistical analysis. D.G., M.L., G.B., M.I.M., and K.E. wrote the paper. D.G. is the gu... | PMC10850008 | ||
Funding | This study was funded in part by the Associazione “Salute con Stile” (no. 1.2022) (Naples, Italy). Open access funding provided by Università degli Studi della Campania Luigi Vanvitelli within the CRUI-CARE Agreement. | PMC10850008 | ||
Compliance with ethical standards | PMC10850008 | |||
Conflict of interest | D.G. received honoraria for speaking at meetings from Sanofi, Eli Lilly, and Company, AstraZeneca, and Novo Nordisk. M.I.M. received honoraria for speaking at meetings from Novo Nordisk, Sanof, and Eli-Lilly. K.E. received honoraria for speaking at meetings from Sanofi Aventis, Eli Lilly, and Novo Nordisk. No other pot... | PMC10850008 | ||
Consent to participate | Informed consent was obtained from all individual participants included in the study. | PMC10850008 | ||
Ethics approval | This study was performed in line with the principles of the Declaration of Helsinki. The study protocol was approved by the Medical Ethics Committee of University of Campania Luigi Vanvitelli (prot 731 26.11.2019) and registered at ClinicalTrial.gov NCT04196231. | PMC10850008 | ||
References | PMC10850008 | |||
1. Introduction | age-associated diseases, inflammation, LPS-exposure, sarcopenia | INFLAMMATION, SARCOPENIA, MUSCULOSKELETAL DISORDERS, DISEASES, INFLAMMATORY RESPONSE | These authors contributed equally to this work.Inflammaging is related to cell senescence and reflects an erratic immune system, which promotes age-associated diseases. Exercise and nutrition, particularly omega-3 fatty acids, are able to affect inflammation. Therefore, we examined the effects of an 8-week exercise and... | PMC9863449 |
2. Results | PMC9863449 | |||
2.1. Baseline Characteristics | In total, 61 old adults (70.6 ± 4.7 years; 53% women) were included in the final analysis. The three groups, consisting of either a control, a high-protein (protein), or a high-protein, omega-3-enriched diet (protein + omega-3), showed similar baseline characteristics such as age, sex distribution, body composition ( | PMC9863449 | ||
2.2. Adherence to Interventions and Changes in Body Composition | With regard to our exercise intervention, the participants started with overall comparable physical fitness and showed similar adherence to exercise protocols regarding vibration training as well as home-based exercises (see The high adherence rate of omega-3 supplementation resulted in a significantly increased omega-... | PMC9863449 | ||
2.3. Omega-3 Supplementation Decreased Circulating Inflammatory Markers | To investigate intervention effects on inflammatory markers in old adults, we first assessed the circulating levels of IL-6, IL-10, IL-1 receptor antagonist (IL-1RA), c-c motif chemokine ligand-2 (CCL-2), and high-mobility group box-1 (HMGB-1) in fasting serum samples. According to unadjusted within-group comparisons b... | PMC9863449 | ||
2.4. Gene Expression Levels of Inflammatory Markers in PBMC Are Reduced with Both Protein-Enriched Dietary Interventions | To better understand intervention effects on immune cells in old adults, we analyzed expression levels of genes coding cytokines/chemokines in isolated PBMC. Within-group comparison showed significant reductions in gene expression levels of IL-6 (In women, sex-stratified analyses indicated in the protein as well as the... | PMC9863449 | ||
2.5. Reduction in Ex Vivo LPS-Stimulated Cytokine/Chemokine Release after Exercise and Dietary Interventions | To investigate how exercise and dietary interventions affect the immune cell capacity of old adults, we evaluated the LPS-stimulated secretion levels of cytokines/chemokines in whole-blood cultures. Unadjusted within-group comparison indicated a significantly diminished LPS-induced production of IL-1RA in the protein g... | PMC9863449 | ||
3. Discussion | To the best of our knowledge, the present sub-analysis is the first to investigate the impact of a whey protein-enriched, omega-3-supplemented diet in combination with whole-body vibration training and home-based exercise on the inflammatory status in community-dwelling old adults, using the combination of analyses in ... | PMC9863449 | ||
3.1. Isolated Effects of Exercise Intervention on LPS-Induced Chemokine Release | Details regarding the dietary compliance rates and exercise adherence of our participants were recently published [Another study performing 12 weeks of moderate strength exercises with 45 healthy old women also observed no changes in IL-2, IL-6, IL-10, TNF-α, and interferon-γ, produced by T lymphocytes [Home-based resi... | PMC9863449 | ||
3.2. Decreased Inflammatory Markers in Serum after High-Protein, Omega-3 Enriched Diet | Although there is a lack of knowledge about interaction effects between exercise and omega-3 supplementation, particularly in old adults, it is assumed that omega-3 acts complementary to exercise in immunomodulatory and anti-inflammatory processes [ | PMC9863449 | ||
3.3. Gene Expression Levels of Inflammatory Markers Reduced with Protein-Enriched Diets | We observed significantly lower gene expression levels of | PMC9863449 | ||
3.4. Attenuated or no Change in LPS-Induced Immune Response with Dietary Interventions | In our study, we used the ex vivo whole-blood assay which is a promising method to assess the cytokine release and cell activation in response to dietary or exercise intervention. It has been demonstrated that old compared with young adults show an attenuated pro-inflammatory response to LPS exposure, possibly reflecti... | PMC9863449 | ||
3.5. Sex-Related Differences | inflammation | INFLAMMATION | Since it has been recommended to consider the impact of sex on inflammation even in higher age [ | PMC9863449 |
3.6. Strength and Limitations | INFLAMMATORY RESPONSE | One strength of this trial is the variety of assessments of inflammatory markers in serum, on gene expression level as well as in response to LPS exposure, which allowed us to have a differentiated evaluation of the inflammatory response in old adults. Furthermore, adherence to the exercise and dietary interventions wa... | PMC9863449 | |
4. Materials and Methods | PMC9863449 | |||
4.1. Study Design and Population Sample | This is a sub-analysis of an 8-week randomized controlled intervention trial in a 3-arm design, which has been described elsewhere in detail [ | PMC9863449 | ||
4.2. Anthropometric Measurements | Weight (kg), height (cm), and waist circumference (cm) were measured to subsequently calculate BMI (kg/m | PMC9863449 | ||
4.3. Dietary Assessment | Daily dietary intake was recorded using 3-day dietary protocols and calculated with the nutrition software EBISpro version 2016 (Dr. J. Erhart, Willstätt-Legelshurst, Germany). | PMC9863449 | ||
4.4. Laboratory Assessments | All blood samples were collected between 8 and 10 a.m. after an overnight fast and stored at −80 °C until analysis. Commercial enzyme-linked immunosorbent assays (ELISA) were used to measure serum concentrations (pg/mL) of IL-6, IL-10, IL-1RA, CCL-2 (all BioVendor, Brno, Czech Republic), and HMGB-1 (ng/mL) (IBL Interna... | PMC9863449 | ||
4.5. PBMC Isolation, RNA Extraction, and Gene Expression with qPCR | To isolate PBMC, blood was collected with 8 mL BD VacutainerRibonucleic acid (RNA) was extracted from isolated PBMC using the NucleoSpin | PMC9863449 | ||
4.6. Ex Vivo Whole-Blood LPS Stimulation | Ex vivo stimulation of whole-blood samples with LPS was performed to evaluate immune cell capacity as described previously [ | PMC9863449 | ||
4.7. Whole-Body Vibration Training and Home-Based Resistance Exercise | All participants trained once per week under guidance at the institute on a Galileo | PMC9863449 | ||
4.8. Dietary Intervention | Participants were randomly assigned to either control, high-protein (protein) or high-protein, omega-3-enriched (protein + omega-3) diet groups. While the control group continued their usual diet, both protein-enriched groups received a high-protein diet (1.2–1.5 g protein/kg body weight/day), supported with a daily 30... | PMC9863449 | ||
4.9. Data Analysis | Statistical analyses were performed with SPSS Statistics version 25 (IBM Corp., Chicago/IL, USA). Data distribution was checked using Kolmogorov–Smirnov tests and presented as either mean ± standard deviation or median with interquartile range (IQR). Extreme outliers of relative changes after treatment, identified with... | PMC9863449 | ||
5. Conclusions | Eight weeks of a high-protein, omega-3-enriched diet combined with exercise decreased circulating anti-inflammatory markers IL-10 and IL-1RA. In men, the pro-inflammatory markers IL-6, CCL-2, and HMGB-1 were reduced following a high-protein, omega-3-supplemented diet. A high-protein diet attenuated anti-inflammatory IL... | PMC9863449 | ||
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC9863449 | ||
Author Contributions | C.H. | The authors’ responsibilities were as follows—conceptualization, U.H., O.P.-R. and K.N.; funding acquisition, U.H.; collection of data, U.H.; laboratory assessments, S.H., B.K. and C.H.; statistical analysis, U.H. and S.H.; writing—original draft preparation, U.H. and S.H.; writing—review and editing, B.K., C.H., O.P.-... | PMC9863449 | |
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the University of Potsdam ethics committee (protocol code 58/2019 and date of approval: 21 October 2019). | PMC9863449 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9863449 | ||
Data Availability Statement | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC9863449 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders and sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC9863449 | ||
Abbreviations | PMC9863449 | |||
References | Fasting serum concentrations of (Gene expression levels analyzed in peripheral blood mononuclear cells of (Ex vivo whole-blood LPS-induced concentrations of (Baseline characteristics and inflammatory markers, displayed for control, high-protein (protein), and high-protein, omega-3 enriched (protein + omega-3) groups.Co... | PMC9863449 | ||
Background | depressive, depression, psychiatric | Current psychiatric epidemiological evidence estimates that 17% of young adults (aged 18-25 years) experienced a major depressive episode in 2020, relative to 8.4% of all adults aged ≥26 years. Young adults with a major depressive episode in the past year are the least likely to receive treatment for depression compare... | PMC10369163 | |
Objective | depression | We conducted a randomized clinical trial following our initial 4-week SMS text message–delivered cognitive behavioral therapy (CBT-txt) for depression in young adults. We sought to test mechanisms of change for CBT-txt. | PMC10369163 | |
Methods | depressive, Depression, cognitive distortions, depressive symptoms | Based on participant feedback, outcome data, and the empirical literature, we increased the treatment dosage from 4-8 weeks and tested 3 mechanisms of change with 103 young adults in the United States. Participants were from 34 states, recruited from Facebook and Instagram and presenting with at least moderate depressi... | PMC10369163 | |
Results | depressive symptoms | Across all 3 months of the study, participants in the CBT-txt group showed significantly larger decreases in depressive symptoms than those in the control group ( | PMC10369163 | |
Conclusions | depressive | Results provide evidence for the efficacy of CBT-txt to reduce young adult depressive symptoms through hypothesized mechanisms. To the best of our knowledge, CBT-txt is unique in its SMS text message–delivered modality, the strong clinical evidence supporting efficacy and mechanisms of change. | PMC10369163 | |
Trial Registration | ClinicalTrials.gov NCT05551702; https://clinicaltrials.gov/study/NCT05551702 | PMC10369163 | ||
Introduction | PMC10369163 | |||
Background | depressive, depression | In 2020, young adults (ages 18-25 years) in the United States experienced more major depressive episodes than other age groups and were the least likely to receive treatment for depression (eg, talking with a health provider or taking prescription medication) [Even when the rates for the treatment of depression rose na... | PMC10369163 | |
Mobile Health Treatments | depression | Creative mental health treatment strategies are needed to reach young adults to address this unmet need. Digitally delivered mobile health (mHealth) treatments (or mHealth interventions) show promise for reaching young adults and serving as a clinical tool to address depression in young adults. Because mHealth interven... | PMC10369163 | |
Clinical Foundation | depressive | This study was conducted to better understand the mechanisms of SMS text message–delivered cognitive behavioral therapy (CBT-txt) as well as the acceptability of the treatment length. Our recent randomized clinical trial treating 102 young adults in the United States with at least moderate depressive symptomatology fou... | PMC10369163 | |
This Study | depressive | Four hypotheses were tested for this follow-up study. The first hypothesis was that participants allocated to the treatment condition would show greater reductions in their depressive symptoms immediately following treatment (2 months after enrollment) and at the 3-month follow-up than participants in the waitlist cont... | PMC10369163 | |
Methods | PMC10369163 | |||
Procedures | RECRUITMENT | In total, 103 young adults (ages 18-25 years) were recruited and enrolled in a 3-month randomized clinical trial. Participants were recruited using age-targeted advertising on Facebook and Instagram for young adults residing in the United States. Recruitment occurred over a 7-week period from July 6 to August 28, 2022.... | PMC10369163 | |
Design | The study design was a 2-arm randomized clinical trial with participants allocated to either the experimental condition or the waitlist control condition. Eligibility requirements were (1) age between 18 and 25 years; (2) a score of at least 10 on the Patient Health Questionnaire–9 (PHQ-9) [ | PMC10369163 | ||
Remote Data Collection Quality Control | Data were reviewed carefully on a daily basis for quality control. Beginning July 26, 2022, we noticed increased screening activity with similar name patterns. After carefully reviewing the screening data, including the name, mailing address, IP address, phone number with area code and service carrier, and survey respo... | PMC10369163 | ||
Text-Delivered Treatment: CBT-txt | PMC10369163 | |||
Overview | CBT-txt was adapted from an evidenced-based, in-person CBT treatment manual [ | PMC10369163 | ||
Theoretical Underpinnings of CBT-txt | depression | DISORDERS | The theory underlying CBT-txt is the Generic Cognitive Model, which specifies common cognitive and behavioral processes associated with disorders such as depression [ | PMC10369163 |
Clinical Structure of CBT-txt | adult abuse | ABUSE, ADULT ABUSE | We expanded our initial 4-week CBT-txt treatment [SMS text message–delivered cognitive behavioral therapy (CBT) content and structure (474 texts over 8 weeks; mean 14.8 texts per day, every other day).Participants assigned to the CBT-txt intervention condition received 474 texts delivered every other day over a 64-day ... | PMC10369163 |
Example of a texting conversation over 1 day. (The italicized text is autopopulated by programming and is programming logic; it is not shown to the participant. This limited example of SMS text message–delivered cognitive behavioral therapy does not provide the context of previous texting conversations or subsequent co... | depressed, bad feelings | Hi Let’s look at how thoughts, what we tell ourselves, affect our mood. We are usually not aware of these negative thinking patterns that influence our moodText We actually fool ourselves and create more bad feelings about things that are *simply not true.* Our depressed thinking keeps us in this cycle.Study the list c... | PMC10369163 | |
Fidelity of CBT-txt | We followed previous successful research in developing text-delivered interventions derived from in-person treatments [ | PMC10369163 | ||
Participant Safety Protocol | Depression | We instituted a participant safety protocol that reviewed all incoming texts for crisis-related words both automatically (ie, autotext review) and with staff reading every text from all participants at least once per day. If participants indicated SI on the Beck Depression Inventory-II (BDI-II) or if their follow-up BD... | PMC10369163 | |
Measures | PMC10369163 | |||
Demographics | depression | Participant age, sex, race and ethnicity, socioeconomic status, family history of depression, and current use of antidepressant medication were collected at the baseline assessment. | PMC10369163 | |
Acceptability and Engagement | Participants’ acceptability of the intervention was measured via participant-reported satisfaction with the intervention as well as passively collected engagement with the intervention content and features. Satisfaction was assessed using a measure developed in our past work [ | PMC10369163 | ||
Screen of Depression Symptoms | The PHQ-9 was used to determine eligibility [ | PMC10369163 | ||
Depression Symptoms and Severity | depression | Baseline and follow-up assessment of depression severity was assessed with BDI-II [ | PMC10369163 | |
Behavioral Activation | Depression | Behavioral activation was measured using the Behavioral Activation for Depression Scale, Short Form [ | PMC10369163 | |
Perseverative Thinking | Repetitive negative thinking was measured using the Perseverative Thinking Questionnaire (PTQ) [ | PMC10369163 | ||
Cognitive Distortion | Cognitive distortion | Cognitive distortion was measured using the Cognitive Distortions Scale (CDS) [ | PMC10369163 | |
Statistical Analyses | PMC10369163 | |||
Latent Change Score Modeling | Latent change score (LCS) analyses were conducted in a structural equation modeling framework using the | PMC10369163 | ||
Mediation Analysis | Depression | Mediation was also tested in LCS models. LCSs were created for (1) the baseline to 3-month change in the mediator (Behavioral Activation for Depression Scale, CDS, and PTQ in separate models) and (2) the baseline to 3-month change in the outcome (BDI-II). Pretreatment mediator and BDI-II scores at baseline were include... | PMC10369163 | |
Ethics Approval | All procedures were approved by the institutional review board of The University of Tennessee (approval UTK IRB-20-06164-FB). | PMC10369163 | ||
Results | PMC10369163 | |||
Demographic Results | Our sample size was 103. The participants’ mean age was 22 (SD 2.2) years and 84.5% (87/103) were female, and they resided in 34 different states in the United States and the District of Columbia. The sample comprised 15.5% (16/103) Asian, 3.9% (4/103) Black or African American, 7.8% (8/103) Hispanic or Latino, 8.7% (9... | PMC10369163 | ||
Acceptability and Engagement | depression | Participants endorsed levels of acceptability and engagement similar to our previous pilot of CBT-txt for young adult depression. Two-thirds (69/103, 67%) of the participants completed the intervention (responding to ≥95% of intervention texts), although somewhat lower than in our previous pilot (85%) [ | PMC10369163 | |
LCS Results | PMC10369163 | |||
Clinical Significance | Depression | We used 2 measures of clinical significance. First, the number of participants at the end of the trial with high-end state functioning as defined by Jacobson and Truax [Depression severity level (BDI-II categories) percentages at 3 months by condition. | PMC10369163 | |
Discussion | PMC10369163 | |||
Principal Findings | depression, depressive symptoms | RECRUITMENT | The findings from this investigation contribute to the mHealth literature by providing convincing evidence that text-delivered CBT treatment can significantly and consistently reduce depressive symptoms in young adults. These findings also specify 3 treatment mechanisms that each explain a significant portion of the tr... | PMC10369163 |
Limitations | depressive | The study results should be considered in light of the following limitations. First, although this study was structured as a follow-up pilot study, having a larger sample size and longer follow-up periods may strengthen confidence in the findings. Second, the sample was 84% female, limiting the generalization across bi... | PMC10369163 | |
Abbreviations | depressive, Depression | Beck Depression Inventory-IIcognitive behavioral therapySMS text message–delivered cognitive behavioral therapyCognitive Distortions ScaleConsolidated Standards of Reporting Trialslatent change scoremajor depressive disordermobile healthPatient Health Questionnaire–9Perseverative Thinking Questionnairereliable change i... | PMC10369163 | |
Introduction | children)Additional, myopic | MYOPIA, PCT | Sufficient outdoor time is a widely accepted method for preventing myopiaFortunately, some clinical trials have discovered a novel and intriguing intervention—which has many different names, e.g., low-level laser therapy (LLLT)The first well-designed randomized controlled study also reported that this special red light... | PMC9969012 |
Methods | PMC9969012 | |||
Study design | EYE | This 12-month clinical trial was designed to be a randomized, controlled, parallel study with follow-up visits every 3 months. Potentially eligible children were recruited from the hospital after a screening visit.The trial was designed to begin in February 2021 and end in June 2023. All subjects were enrolled at the O... | PMC9969012 | |
Eligibility criteria | optic nerve dysfunction, astigmatism, amblyopia, optic media lesions, cataract, glaucoma, retinal lesions | ASTIGMATISM, AMBLYOPIA, EYE DISEASES, CATARACT, GLAUCOMA | The inclusion criteria were as follows: (1) the subject's guardian agreed to participate in the study and signed a written informed consent form; if the subject could express his or her willingness to participate in the trial, the subject's consent was also obtained; (2) age 3–16 years old (including the boundary value... | PMC9969012 |
Interventions and visits | SFChT, diopter | CYCLOPLEGIA, ACD | All spectacle lenses were made for single focus with full correction for each subject as the first intervention throughout the whole procedure for both groups. PBM therapy was performed with a low-intensity laser (LD-A, Jilin Londa Optoelectronics Technology, Jilin, China) with an irradiance of 0.35 ± 0.02 mW/cmDuring ... | PMC9969012 |
Evaluated parameters | SFChT, myopia | MYOPIA, SECONDARY, ACD | The primary outcome variables were changes in AL and SER compared to baseline. SER (sphere plus half cylinder) from the pattern of five measurements was measured at least 30 min after instillation of 2 drops of 1% cyclopentolate administered every 5 min. AL was measured by calculating the average of five measurements o... | PMC9969012 |
Sample size calculation | Power Analysis and Sample Size Software (PASS 2022) (NCSS, LLC. Kaysville, Utah, USA) was used to determine that the minimum sample size was 24. A previous study found that the rate of AL change was approximately 0.25 mm/year (0.13 mm/year vs. 0.38 mm/year) slower in participants treated with repeated low-level red lig... | PMC9969012 |
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