Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study.
BMC surgery. 2021;(1):298
BACKGROUND Bariatric surgery may be indicated in patients with nonalcoholic fatty liver disease (NAFLD) to achieve and maintain the degree of weight loss required to ensure therapeutic effects. However, bariatric surgery is still underrecognized in the treatment of NAFLD, including its inflammatory subtype, nonalcoholic steatohepatitis (NASH). Moreover, there is a lack of follow-up outcome data on different types of bariatric surgery in patients with NAFLD. This study aims to adequately assess the effect of bariatric surgery on NAFLD remission in obese patients. METHODS This prospective multicentre observational follow-up study will include 142 obese patients with NAFLD scheduled to undergo one of the following surgical procedures: sleeve gastrostomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass. The primary outcome is the complete remission rate of NAFLD one year postoperatively, which is defined by liver fat fraction < 5% on magnetic resonance imaging; the secondary outcomes includes (i) changes in NASH and liver fibrosis biopsy findings, (ii) changes in body weight and abdominal adipose weight, (iii) resolution of obesity-related comorbidities, and (iv) incidence of adverse events. A long-term follow-up related to this study will also be conducted. DISCUSSION This study will provide a necessary and preliminary foundation for the early identification and targeted treatment of patients with NAFLD who can be referred for bariatric surgery, as indicated for management of obesity and metabolic disease. TRIAL REGISTRATION Clinicaltrials.gov: NCT04366999. Registered 21 April 2020. ( https://clinicaltrials.gov/ct2/show/NCT04366999 ).
Rapid reduction in plaque inflammation by sonodynamic therapy inpatients with symptomatic femoropopliteal peripheral artery disease:A randomized controlled trial.
International journal of cardiology. 2021;:132-139
BACKGROUND Inflammation is actively involved in the clinical manifestation of peripheral artery disease (PAD). Sonodynamic therapy (SDT), a novel non-invasive, plaque-based, macrophage-targeted anti-inflammatory regimen for atherosclerosis has the potential to improve walking performance by reducing plaque inflammation. METHODS This phase-2, randomized, sham-controlled, double-blind clinical trial enrolled 32 participants with symptomatic femoropopliteal PAD. The primary outcome was the 30-day change in the target-to-background ratio (TBR) within the most diseased segment (MDS) of the femoropopliteal artery assessed through positron emission tomography/computed tomography (PET/CT). The secondary outcomes were changes in walking performance, limb perfusion, lesional morphology and quality of life measurements. RESULTS The mean age was 64.7 years and 63% were male. Thirty-one completed follow-up. SDT significantly decreased the MDS TBR by 0.53 (95% CI, -0.70 to -0.36, P < 0.001) compared with control. Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P < 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P < 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P < 0.001) and 9.6% (95% CI, -24.5 to -5.3, P = 0.005), respectively, and increased the walking speed score of the Walking Impairment Questionnaire by 16.1 (95% CI, 2.6 to 29.5, P = 0.021) and the physical functioning score of the 36-item Short-Form Health Survey by 10.0 (95% CI, 5.0 to 20.0, P = 0.003) compared with control. These improvements were maintained in the SDT group up to 6-month. CONCLUSIONS SDT rapidly reduced plaque inflammation and improved walking performance among patients with symptomatic PAD. TRIAL REGISTRATION Clinical Trials NCT03457662.
The efficacy and safety of Yijinjing exercise in the adjuvant treatment of ankylosing spondylitis: A protocol of randomized controlled trial.
BACKGROUND Ankylosing spondylitis (AS) is a chronic systemic autoimmune disease with high disability rate. Conventional treatment regimens have long medication cycles and are associated with adverse reactions. Therapeutic exercise is also considered to be an effective treatment for AS. Evidence suggests that Yijinjing as a low-energy exercise has advantages in adjuncting AS, but there is a lack of standard clinical studies to evaluate its efficacy and safety. METHODS This is a prospective randomized controlled trial to investigate the efficacy and safety of Yijinjing in the adjuvant treatment of AS. Approved by the Clinical Research Ethics Association of our hospital, patients were randomly divided into treatment or control groups in a ratio of 1:1. The treatment group received 4-month Yijinjing training on the basis of conventional treatment, while the control group received conventional treatment and maintained their current lifestyle. The outcome indicators included: activity index, functional ability, Bath Ankylosing Spondylitis Metrology Index, adverse reaction, etc. Finally, SPASS 22.0 software was used for statistical analysis of the data. DISCUSSION This study evaluated the clinical efficacy of Yijinjing exercise in the adjuvant treatment of AS, and the results of our study will provide a reference for the clinical use of Yijinjing exercise as an effective complementary alternative for the treatment of AS.
Individual breastfeeding support with contingent incentives for low-income mothers in the USA: the 'BOOST (Breastfeeding Onset & Onward with Support Tools)' randomised controlled trial protocol.
BMJ open. 2020;(6):e034510
INTRODUCTION National breastfeeding rates have improved in recent years, however, disparities exist by socioeconomic and psychosocial factors. Suboptimal breastfeeding overburdens the society by increasing healthcare costs. Existing breastfeeding supports including education and peer support have not been sufficient in sustaining breastfeeding rates especially among low-income women. The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding among mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC). METHODS AND ANALYSIS This trial uses a parallel randomised controlled trial. This trial is conducted at two sites in separate states in the USA. Mothers who were enrolled in WIC and initiated breastfeeding are eligible. Participants (n=168) are randomised into one of the two study groups: (1) standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding. All participants receive standard breastfeeding services from WIC, home-based individual support and assessments. Participants in SC receive financial compensation based on the number of completed monthly home visits, paid in a lump sum at the end of the 6-month intervention period. Participants in SC +BFI receive an escalating magnitude of financial incentives contingent on observed breastfeeding, paid monthly during the intervention period, as well as bonus incentives for selecting full breastfeeding food packages at WIC. The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC. The primary outcome is the rate of any breastfeeding over 12 months. Randomisation is completed in an automated electronic system. Staff conducting home visits for support and assessments are blinded to study groups. ETHICS AND DISSEMINATION The Advarra Institutional Review Board has approved the study protocol (Pro00033168). Findings will be disseminated to our participants, scientific communities, public health officials and any other interested community members. TRIAL REGISTRATION NUMBER NCT03964454.
Sedentary behavior relates to mental distress of pregnant women differently across trimesters: An observational study in China.
Journal of affective disorders. 2020;:187-193
BACKGROUND The independent effect of sedentary behavior (SB) on maternal mental health is still unclear. The purpose of this study was to examine the different relationships of SB with maternal distress in pregnant women across the three trimesters, controlling for the confounding factors including physical activity (PA), diet and gestational weight gain. METHODS Survey data were collected from 1272 participants in different trimesters of pregnancy. The data were divided into three data sets based on trimester, and regression analysis was conducted on each data set. Both the linear and quadratic relationships between SB and mental distress were estimated. RESULTS There was no significant association between SB and any mental distress symptoms in the first trimester. In the second trimester, SB was positively associated with higher mental overall distress symptoms (β=0.34, P < 0.001), including depress and anxiety. There is an inverted-U shaped curvilinear relationship between SB and mental distress in the third trimester, as SB-squared is significantly associated with mental overall distress (GSI: β=-0.65, P = 0.002, depression: β=-0.53, P = 0.014, anxiety: β=-0.46, P = 0.031). LIMITATIONS The data were collected from only one city in China, which may limit the generalizability of the findings for all Chinese women. This was an observational study and causality cannot be established. CONCLUSION This study found that the relationship between SB and maternal mental distress depends on trimesters. The stage of pregnancy should be considered when designing interventions for pregnant women to change SB to reduce mental distress.
Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy: The COAPT Trial.
Circulation. Heart failure. 2020;(11):e007293
BACKGROUND In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT. METHODS Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use. RESULTS Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%, P=0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted Pinteraction=0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted Pinteraction=0.14) and HF hospitalization (adjusted Pinteraction=0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity. CONCLUSIONS In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.
Effect of Tai Chi Training on Plantar Loads during Walking in Individuals with Knee Osteoarthritis.
BioMed research international. 2020;:3096237
Tai Chi is an available method for the treatment of knee osteoarthritis (KOA). The impacts of Tai Chi on plantar loads of individuals with KOA are not fully understood. 46 participants with knee osteoarthritis were randomly assigned into the Tai Chi group (n = 23) or the control group (n = 23). The Tai Chi group attended a 6-month Tai Chi program, and the control group participated in a wellness education program. Novel Pedar-X system was used to collect the peak pressure (PP) and maximum force (MF) during walking before and 6 months after the intervention. Significant higher peak pressure and maximum force were observed in the 4th and 5th metatarsophalangeal joints in the Tai Chi group. However, there were significant declines in the peak pressure of the whole foot and the 2nd and 3rd metatarsophalangeal joints and maximum force of the heel in the control group. These results suggested that individuals with KOA might change the pattern of plantar loads during walking through Tai Chi, and plantar loads would be useful as a parameter to assess the effect of Tai Chi on knee osteoarthritis. This trial is registered with Clinical Trials: CHiCTR-TRC-13003264.
Dietary supplementation of artificial sweetener and capsicum oleoresin as a strategy to mitigate the negative consequences of heat stress on pig performance.
Journal of animal science. 2020;(5)
Pigs exposed to elevated ambient temperatures exhibit reduced daily gain, alterations in muscle and fat deposition, and decreased health. Negative aspects of gastrointestinal (GI) function, integrity, and permeability also occur. High-intensity sweeteners can ameliorate the negative effects of heat stress (HS) by increasing GI glucagon-like peptide-2 production while capsicum oleoresin has been shown to reduce inflammatory response. The effects of an artificial high-intensity sweetener and capsicum oleoresin (CAPS-SUC; TakTik X-Hit, Pancosma, Switzerland) on growth performance of pigs were examined. Forty-eight pigs (12 wk of age, 43.2 ± 4.3 kg) were assigned to six treatments: thermoneutral conditions (21 ± 1.1 °C; 40% to 70% relative humidity) fed ad libitum with (TN+) or without supplement (TN-), heat stress (35 ± 1 °C; 20% to 40% relative humidity) fed ad libitum with (HS+) or without supplement (HS-), and thermoneutral conditions pair-fed to HS intake with (PFTN+) or without supplement (PFTN-). Supplementation (0.1 g/kg feed) began 2 d prior to the 3-d environmental treatment period. Body weights (BWs) and blood samples were collected on days -1 and 3. Rectal temperature (RT) and respiration rate (RR) were measured thrice daily and the feed intake (FI) was recorded daily. Intestinal sections were collected for histology. Pigs in HS conditions exhibited increased RT (~1.2 °C) and RR (~2.7-fold) compared with TN and PFTN groups (P < 0.01). HS+ animals had increased RR when compared with HS- animals (P < 0.02). Heat stress decreased FI compared with TN. HS and PFTN decreased (P < 0.05) average daily gain compared with TN. Supplement did not alter the BW gain. HS and PFTN decreased (P < 0.05) Gain:Feed compared with TN during environmental treatment. Supplementation with CAPS-SUC increased Gain:Feed by 0.12 (P < 0.05). Circulating glucose concentrations tended to decrease in CAPS-SUC vs. non-supplemented HS and PFTN animals (P ≤ 0.1). Circulating insulin concentrations as well as monocyte count increased in HS compared with PFTN (P < 0.04) but did not differ from TN and likely linked to altered FI. CAPS-SUC increased basophil count (P < 0.02), irrespective of environment. Ileal villus height tended to decrease during HS and PFTN compared with TN (P < 0.08), indicating an effect of intake. Overall, CAPS-SUC supplementation increased pig feed efficiency and may improve immune response.
Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes.
Cell metabolism. 2020
Plain language summary
The novel coronavirus disease 2019 (COVID-19) is caused by infection from the newly emerged, highly contagious coronavirus SARS-CoV-2. The aim of this study was to analyse the association between plasma glucose levels and clinic outcomes in COVID-19 patients with type 2 diabetes (T2D). The study is a retrospective longitudinal, multi-centre study from a cohort of 7,337 COVID-19 cases enrolled among 19 hospitals. Results show that patients with pre-existing T2D received significantly more intensive integrated treatments to manage their symptoms of COVID-19 than the non-diabetic subjects. Furthermore, findings indicate that well-controlled blood glucose was associated with a markedly improved outcome of patients with COVID-19 and pre-existing T2D. Authors conclude that T2D is an important risk factor for COVID-19 progression and adverse endpoints, and well-controlled blood glucose is associated with a significant reduction in the composite adverse outcomes and death.
Type 2 diabetes (T2D) is a major comorbidity of COVID-19. However, the impact of blood glucose (BG) control on the degree of required medical interventions and on mortality in patients with COVID-19 and T2D remains uncertain. Thus, we performed a retrospective, multi-centered study of 7,337 cases of COVID-19 in Hubei Province, China, among which 952 had pre-existing T2D. We found that subjects with T2D required more medical interventions and had a significantly higher mortality (7.8% versus 2.7%; adjusted hazard ratio [HR], 1.49) and multiple organ injury than the non-diabetic individuals. Further, we found that well-controlled BG (glycemic variability within 3.9 to 10.0 mmol/L) was associated with markedly lower mortality compared to individuals with poorly controlled BG (upper limit of glycemic variability exceeding 10.0 mmol/L) (adjusted HR, 0.14) during hospitalization. These findings provide clinical evidence correlating improved glycemic control with better outcomes in patients with COVID-19 and pre-existing T2D.
Concurrent validity of the ActiGraph GT3X+ and activPAL for assessing sedentary behaviour in 2-3-year-old children under free-living conditions.
Journal of science and medicine in sport. 2020;(2):151-156
OBJECTIVES ActiGraph accelerometer cut-points are commonly used to classify sedentary behaviour (SB) in young children. However, they vary from 5counts/5s to 301counts/15s, resulting in different estimates and inconsistent findings. The aim was to examine the concurrent validity of ActiGraph GT3X+cut-points against the activPAL for measuring SB in 2-3-year-olds during free-living conditions. DESIGN Observational validation-study. METHODS Sixty children were fitted with the activPAL and ActiGraph simultaneously for at least 2h. Nine ActiGraph cut-points ranging from 60 to 1488 counts per minute were used to derive SB. Bland & Altman plots and equivalent tests were performed to assess agreement between methods. RESULTS Estimates of SB according to the different ActiGraph cut-points were not within the activPAL ±10% equivalent interval (-4.05; 4.05%). The ActiGraph cut-points that showed the lower bias were 48counts/15s (equivalence lower limit: p= 0.597; equivalence upper limit: p<0.001; bias: -4.46%; limits of agreement [LoA]: -21.07 to 30.00%) and 5counts/5s (equivalence lower limit: p<0.001; equivalence upper limit: p= 0.737; bias: -5.11%; LoA: 30.43 to 20.20%). For the 25counts/15s, 37counts/15s and 48counts/15s ActiGraph cut-points, the upper limits were within the equivalent interval (p<0.001) but not the lower limits (p>0.05). When using the 5counts/5s and 181counts/15s ActiGraph cut-points, lower limits were within the equivalent interval (p<0.001) but not the upper limits (p>0.05). Confidence intervals of the remaining ActiGraph cut-points lie outside the equivalent interval. CONCLUSIONS Although none of the ActiGraph cut-points provided estimates of SB that were equivalent to activPAL; estimates from 48counts/15s and 5counts/5s displayed the smallest mean bias (˜5%).