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Electrolyte Beverage Intake to Promote Hydration and Maintain Kidney Function in Guatemalan Sugarcane Workers Laboring in Hot Conditions.
Krisher, L, Butler-Dawson, J, Yoder, H, Pilloni, D, Dally, M, Johnson, EC, Jaramillo, D, Cruz, A, Asensio, C, Newman, LS
Journal of occupational and environmental medicine. 2020;(12):e696-e703
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Abstract
OBJECTIVES To evaluate impact of electrolyte supplementation on hydration status and health outcomes in Guatemalan agricultural workers performing heavy work under hot climatic conditions. METHODS A 3-week pragmatic trial was conducted with a group of 50 workers during the 2017 to 2018 sugarcane harvest. Workers received an electrolyte hydration intervention during 2 of the 3 weeks. Blood and urine samples were collected each week. RESULTS Increased electrolyte intake resulted in less muscle injury. Kidney function was maintained across the intervention period. Workers were adequately hydrated and average electrolyte levels remained in normal ranges. Mild indications of hyponatremia occurred at higher levels of fluid intake. CONCLUSIONS This trial demonstrates the feasibility of maintaining workers' electrolyte levels under extremely hot and humid conditions while mitigating muscle injury. Electrolyte supplementation should be added to standard workplace water, rest, and shade interventions to protect workers.
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Electronic Decision Support for Management of CKD in Primary Care: A Pragmatic Randomized Trial.
Peralta, CA, Livaudais-Toman, J, Stebbins, M, Lo, L, Robinson, A, Pathak, S, Scherzer, R, Karliner, LS
American journal of kidney diseases : the official journal of the National Kidney Foundation. 2020;(5):636-644
Abstract
RATIONALE & OBJECTIVE Most adults with chronic kidney disease (CKD) in the United States are cared for by primary care providers (PCPs). We evaluated the feasibility and preliminary effectiveness of an electronic clinical decision support system (eCDSS) within the electronic health record with or without pharmacist follow-up to improve the management of CKD in primary care. STUDY DESIGN Pragmatic cluster-randomized trial. SETTING & PARTICIPANTS 524 adults with confirmed creatinine-based estimated glomerular filtration rates of 30 to 59mL/min/1.73m2 cared for by 80 PCPs at the University of California San Francisco. Electronic health record data were used for patient identification, intervention deployment, and outcomes ascertainment. INTERVENTIONS Each PCP's eligible patients were randomly assigned as a group into 1 of 3 treatment arms: (1) usual care; (2) eCDSS: testing of creatinine, cystatin C, and urinary albumin-creatinine ratio with individually tailored guidance for PCPs on blood pressure, potassium, and proteinuria management, cardiovascular risk reduction, and patient education; or (3) eCDSS plus pharmacist counseling (eCDSS-PLUS). OUTCOMES The primary clinical outcome was change in blood pressure over 12 months. Secondary outcomes were PCP awareness of CKD and use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and statin therapy. RESULTS All 80 eligible PCPs participated. Mean patient age was 70 years, 47% were nonwhite, and mean estimated glomerular filtration rate was 56±0.6mL/min/1.73m2. Among patients receiving eCDSS with or without pharmacist counseling (n=336), 178 (53%) completed laboratory measurements and 138 (41%) had laboratory measurements followed by a PCP visit with eCDSS deployment. eCDSS was opened by the PCP for 102 (74%) patients, with at least 1 suggested order signed for 83 of these 102 (81%). Changes in systolic blood pressure were-2.1±1.5mm Hg with usual care, -2.8±1.8mm Hg with eCDSS, and -1.1±1.1 with eCDSS-PLUS (P=0.7). PCP awareness of CKD was 16% with usual care, 26% with eCDSS, and 32% for eCDSS-PLUS (P=0.09). In as-treated analyses, PCP awareness of CKD was significantly greater with eCDSS and eCDSS-PLUS (73% and 69%) versus usual care (47%; P=0.002). LIMITATIONS Recruitment of smaller than intended sample size and limited uptake of the testing component of the intervention. CONCLUSIONS Although we were unable to demonstrate the effectiveness of eCDSS to lower blood pressure and uptake of the eCDSS was limited by low testing rates, eCDSS use was high when laboratory measurements were available and was associated with higher PCP awareness of CKD. FUNDING Grants from government (National Institutes of Health) and not-for-profit (American Heart Association) entities. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study number NCT02925962.
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Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial.
Bethel, MA, Mentz, RJ, Merrill, P, Buse, JB, Chan, JC, Goodman, SG, Iqbal, N, Jakuboniene, N, Katona, B, Lokhnygina, Y, et al
Diabetes care. 2020;(2):446-452
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Abstract
OBJECTIVE To evaluate the impact of once-weekly exenatide (EQW) on microvascular and cardiovascular (CV) outcomes by baseline renal function in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). RESEARCH DESIGN AND METHODS Least squares mean difference (LSMD) in estimated glomerular filtration rate (eGFR) from baseline between the EQW and placebo groups was calculated for 13,844 participants. Cox regression models were used to estimate effects by group on incident macroalbuminuria, retinopathy, and major adverse CV events (MACE). Interval-censored time-to-event models estimated effects on renal composite 1 (40% eGFR decline, renal replacement, or renal death) and renal composite 2 (composite 1 variables plus macroalbuminuria). RESULTS EQW did not change eGFR significantly (LSMD 0.21 mL/min/1.73 m2 [95% CI -0.27 to 0.70]). Macroalbuminuria occurred in 2.2% of patients in the EQW group and in 2.5% of those in the placebo group (hazard ratio [HR] 0.87 [95% CI 0.70-1.07]). Neither renal composite was reduced with EQW in unadjusted analyses, but renal composite 2 was reduced after adjustment (HR 0.85 [95% CI 0.74-0.98]). Retinopathy rates did not differ by treatment group or in the HbA1c-lowering or prior retinopathy subgroups. CV outcomes in those with eGFR <60 mL/min/1.73 m2 did not differ by group. Those with eGFR ≥60 mL/min/1.73 m2 had nominal risk reductions for MACE, all-cause mortality, and CV death, but interactions by renal function group were significant for only stroke (HR 0.74 [95% CI 0.58-0.93]; P for interaction = 0.035) and CV death (HR 1.08 [95% CI 0.85-1.38]; P for interaction = 0.031). CONCLUSIONS EQW had no impact on unadjusted retinopathy or renal outcomes. CV risk was modestly reduced only in those with eGFR ≥60 mL/min/1.73 m2 in analyses unadjusted for multiplicity.
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A 3-year prospective study on the metabolic effect of aripiprazole, quetiapine and ziprasidone: A pragmatic clinical trial in first episode psychosis patients.
Vázquez-Bourgon, J, Ibáñez Alario, M, Mayoral-van Son, J, Gómez Revuelta, M, Ayesa Arriola, R, Juncal Ruiz, M, Ortiz-García de la Foz, V, Crespo Facorro, B
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 2020;:46-55
Abstract
Schizophrenia is a severe brain disorder with an excess morbidity and mortality partly due to a higher incidence of metabolic disturbances and cardio-vascular events. The exposure to antipsychotic treatment has been observed linked to these metabolic abnormalities. This study explores the metabolic effects of aripiprazol, quetiapine and ziprasidone in drug-naïve patients with a first-episode of psychosis, at long-term. Two-hundred and two patients with first-episode of psychosis were included in the study. Patients were randomly assigned to receive quetiapine, ziprasidone, or aripiprazole. Clinical, sociodemographic and anthropometric measures, as well as lipid and glyceamic parameters, were recorded at baseline and after three years of initiating antipsychotic treatment. Body weight and BMI increased significantly after 3 years of follow-up (F = 35.0, p<0.001; and F = 37.6, p<0.001, respectively). Most of the increase in weight occurred within the first year of treatment. The proportion of patients meeting criteria for obesity (5.6% vs 25.7%; p<0.001), hypercholesterolemia (23.2% vs 41.7%; p<0.001) and hypertriglyceridemia (5.8% vs 23.0%; p<0.001) increased significantly. Head-to-head comparisons between antipsychotic groups revealed that the ziprasidone group presented significantly smaller increments in weight (p = 0.034) and BMI (p = 0.020) than aripiprazole group. After 3 years of having presented a first episode of psychosis, patients show significant increments in body weight and BMI, as well as in lipid and glycaemic parameters leading to clinical metabolic disturbances. In this context, the first year is the critical period for weight gain and development of metabolic changes. In this study, ziprasidone produced smaller weight gain than aripiprazole.
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Washing with water alone versus soap in maintaining remission of eczema.
Inuzuka, Y, Natsume, O, Matsunaga, M, Monna, Y, Okada, E, Kato, Y, Taguchi, T
Pediatrics international : official journal of the Japan Pediatric Society. 2020;(6):663-668
Abstract
BACKGROUND There is no consensus on the use of soap in skin care for atopic dermatitis in Japan. Thus, this study aimed to evaluate the efficacy of soap to maintain eczema remission in atopic dermatitis patients during the fall-winter period in Japan. METHODS This assessor-blinded, pragmatic randomized, non-inferiority study enrolled atopic dermatitis patients whose eczema was controlled by regular steroid ointment application less than or equal to 2 days / week (tacrolimus ointment was permitted). For 8 ± 3 weeks, participants washed their upper and lower limbs on one side with soap (soap side) and on the other side with water alone (water side). The primary outcome was an Eczema Area and Severity Index score at week 8 ± 3. RESULTS Twenty-nine participants were analyzed. The Eczema Area and Severity Index scores at week 8 ± 3 of the water and soap sides were 0.0 (0.0-0.4) and 0.0 (0.0-0.4), respectively (P = 0.18). The difference between both sides was -0.02 (-0.11-0.08), and the limits of the 95% confidence interval did not reach the prespecified non-inferiority margin. The average Patient-Oriented Eczema Measure score was 1.27 ± 1.7 and 1.32 ± 1.8 for the water and soap sides, respectively (P = 0.92). The total number of additional steroid ointment applications was four (0-20) times and six (0-23) times, respectively (P = 0.98). Participants were categorized according to self-assessments of the usefulness of soap, with 2, 24, and 3 participants in the water-effective, invariant, and soap-effective groups, respectively. CONCLUSIONS For children with controlled atopic dermatitis, washing with water alone was not inferior to washing with soap for maintaining remission of eczema during the fall-winter period in Japan.
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A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial.
Nanditha, A, Thomson, H, Susairaj, P, Srivanichakorn, W, Oliver, N, Godsland, IF, Majeed, A, Darzi, A, Satheesh, K, Simon, M, et al
Diabetologia. 2020;(3):486-496
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AIMS/HYPOTHESIS This randomised controlled trial was performed in India and the UK in people with prediabetes to study whether mobile phone short message service (SMS) text messages can be used to motivate and educate people to follow lifestyle modifications, to prevent type 2 diabetes. METHODS The study was performed in people with prediabetes (n = 2062; control: n = 1031; intervention: n = 1031) defined by HbA1c ≥42 and ≤47 mmol/mol (≥6.0% and ≤6.4%). Participants were recruited from public and private sector organisations in India (men and women aged 35-55 years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40-74 years without pre-existing diabetes, cardiovascular disease or kidney disease). Allocation to the study groups was performed using a computer-generated sequence (1:1) in India and by stratified randomisation in permuted blocks in the UK. Investigators in both countries remained blinded throughout the study period. All participants received advice on a healthy lifestyle at baseline. The intervention group in addition received supportive text messages using mobile phone SMS messages 2-3 times per week. Participants were assessed at baseline and at 6, 12 and 24 months. The primary outcome was conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure and quality of life. RESULTS At the 2 year follow-up (n = 2062; control: n = 1031; intervention: n = 1031), in the intention-to-treat population the HR for development of type 2 diabetes calculated using a discrete-time proportional hazards model was 0.89 (95% CI 0.74, 1.07; p = 0.22). There were no significant differences in the secondary outcomes. CONCLUSIONS/INTERPRETATION This trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging. TRIAL REGISTRATION The primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833). FUNDING The study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.
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Behaviour change, weight loss and remission of Type 2 diabetes: a community-based prospective cohort study.
Dambha-Miller, H, Day, AJ, Strelitz, J, Irving, G, Griffin, SJ
Diabetic medicine : a journal of the British Diabetic Association. 2020;37(4):681-688
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Plain language summary
Type 2 Diabetes is considered a lifelong condition, but calorie restriction or weight loss can lead to complete remission. Patients newly diagnosed with Type 2 Diabetic may benefit from behavioural change over the long run. When Type 2 Diabetes is diagnosed early in the disease trajectory, it may increase the patient's motivation and make them more receptive to weight-loss interventions. This prospective cohort study included 865 newly diagnosed Type 2 diabetic patients from the ADDICTION Cambridge Trial, a pragmatic, parallel-group cluster randomised controlled trial. The study assessed the relationship between behaviour change and weight loss and the prospect of type 2 diabetes remission in the first year, following four years and after five years without intense dietary or lifestyle intervention in patients. 30% of the patients achieved diabetes remission at 5-year follow-up, with a significant likelihood of remission among those who achieved ≥ 10% weight loss in the first year of diagnosis. A self-reported change in intake of alcohol units was found to be the only consistent association between behaviour change and remission in this study. The role of behaviour change in the remission of diabetes requires further robust research. This study will help healthcare professionals understand the association between weight loss and remission in diabetic patients.
Abstract
AIM: To quantify the association between behaviour change and weight loss after diagnosis of Type 2 diabetes, and the likelihood of remission of diabetes at 5-year follow-up. METHOD We conducted a prospective cohort study in 867 people with newly diagnosed diabetes aged 40-69 years from the ADDITION-Cambridge trial. Participants were identified via stepwise screening between 2002 and 2006, and underwent assessment of weight change, physical activity (EPAQ2 questionnaire), diet (plasma vitamin C and self-report), and alcohol consumption (self-report) at baseline and 1 year after diagnosis. Remission was examined at 5 years after diabetes diagnosis via HbA1c level. We constructed log binomial regression models to quantify the association between change in behaviour and weight over both the first year after diagnosis and the subsequent 1-5 years, as well as remission at 5-year follow-up. RESULTS Diabetes remission was achieved in 257 participants (30%) at 5-year follow-up. Compared with people who maintained the same weight, those who achieved ≥ 10% weight loss in the first year after diagnosis had a significantly higher likelihood of remission [risk ratio 1.77 (95% CI 1.32 to 2.38; p<0.01)]. In the subsequent 1-5 years, achieving ≥10% weight loss was also associated with remission [risk ratio 2.43 (95% CI 1.78 to 3.31); p<0.01]. CONCLUSION In a population-based sample of adults with screen-detected Type 2 diabetes, weight loss of ≥10% early in the disease trajectory was associated with a doubling of the likelihood of remission at 5 years. This was achieved without intensive lifestyle interventions or extreme calorie restrictions. Greater attention should be paid to enabling people to achieve weight loss following diagnosis of Type 2 diabetes.
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Transitional Hypoglycaemia Management in Small for Gestational Age Neonates with Sucrose Enriched Expressed Breastmilk in Resource Poor Setting.
Bora, R, Deori, S
Journal of tropical pediatrics. 2020;(3):267-274
Abstract
AIM: To find out if oral sucrose is as efficacious as intravenous dextrose (IVDx) in treating hypoglycaemia in small for gestational age (SGA) neonates and to compare risk of feed intolerance (FI) and necrotizing enterocolitis (NEC) in oral therapy with IVDx therapy. METHODS Eighty SGA haemodynamically stable hypoglycaemic [blood sugar (BS) < 40 mg/dl] neonates of ≥32 to ≤36 week gestational age were randomized to receive oral sugar enriched expressed breastmilk (EBM; Group A) or IV dextrose therapy (Group B; 40 in each group) in similar calculated doses. BS at 6 h after treatment, incidence of recurrence of hypoglycaemia, FI and NEC were compared. RESULTS Mean BS level at 6 h after treatment in oral supplementation group was 63.53 ± 22.12 mg/dl [3.52 ± 1.22 mmol/l (IQR 49.2-82 mg/dl, 2.7-4.5 mmol/l) vs. 71.28 ± 31.76 mg/dl [3.96 ± 1.76 mmol/l (IQR 48.5-73 mg/dl, 2.69-4 mmol/l) in IVDx group, p = 0.209. Relative risk (RR) of recurrence of hypoglycaemia in oral vs. IV treatment was 1.5 with 95% CI 0.4578-4.9151. Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable. CONCLUSION In resource poor setting in haemodynamically stable hypoglycaemic SGA neonates, EBM enriched with calculated dose of sucrose given orally maintains euglycaemia (BS 40-125mg/dl, 2.2-6.9 mmol/l) without increased incidence of FI and NEC. This method also prevents lactational failure.
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Combined cranberry supplementation and weight loss diet in non-alcoholic fatty liver disease: a double-blind placebo-controlled randomized clinical trial.
Hormoznejad, R, Mohammad Shahi, M, Rahim, F, Helli, B, Alavinejad, P, Sharhani, A
International journal of food sciences and nutrition. 2020;(8):991-1000
Abstract
A double-blind placebo-controlled randomised clinical trial was conducted on 41 patients with non-alcoholic fatty liver disease (NAFLD). Participants were randomly allocated to receive either a cranberry supplement or a placebo for 12 weeks. Both groups were assigned to follow a weight loss diet. At the end of the study, alanine aminotransferase and insulin decreased significantly in both groups (p < .05); however, this reduction was significantly greater in the cranberry group than in the placebo group (p < .05). Significant improvements in insulin resistance were observed in the cranberry group and between the two groups (p < .001 and p = .020, respectively). Also, there was an improvement in steatosis grade and anthropometric measurements in both groups (p < .05), and there was no significant difference between the two groups in regard to these factors (p > .05). It seems that 288 mg of cranberry extract might improve managing NAFLD, which is equivalent to 26 g of dried cranberry.
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Low-density lipoprotein cholesterol treatment and outcomes in patients with type 2 diabetes and established cardiovascular disease: Insights from TECOS.
De Ferrari, GM, Stevens, SR, Ambrosio, G, Leonardi, S, Armstrong, PW, Green, JB, Wamil, M, Holman, RR, Peterson, ED, ,
American heart journal. 2020;:82-88
Abstract
BACKGROUND Type 2 diabetes (T2D) patients are at increased risk for cardiovascular (CV) events. Most guidelines recommend treating low-density lipoprotein cholesterol (LDL-C) levels to ≤70 mg/dL (1.8 mM) for patients with T2D and established atherosclerotic CV disease, and some a more aggressive target of ≤55 mg/dL (1.4 mM). Our objective was to assess the degree to which these LDL-C targets are achieved in routine practice. METHODS Using data from TECOS, an international pragmatic CV outcomes trial of sitagliptin vs placebo, we assessed lipid-lowering treatment among patients with T2D and CV disease, baseline lipid values, and the association between baseline LDL-C and 5-year risk for major adverse cardiac events (MACE; ie, CV death, nonfatal myocardial infarction, or nonfatal stroke). RESULTS Overall, 11,066 of 14,671 TECOS participants (75.4%) had LDL-C measured at baseline. Median age was 65 years, 72% were male, and median T2D duration was 10 years. Overall, 82.5% of patients were on statins; only 5.8% were on ezetimibe. At baseline, 14.3% had LDL-C ≤55 mg/dL, 18.4% between 55.1 and 70 mg/dL, 35% between 70.1 and 100 mg/dL, and 32.3% >100 mg/dL. Each 10 mg/dL higher LDL-C value was associated with a higher risk of MACE (HR 1.05, 95% CI 1.03-1.07) or CV death (HR 1.06, 95% CI 1.04-1.09). CONCLUSIONS Although most high-risk patients with T2D and CV disease were on lipid-lowering therapy, only 1:3 had LDL-C <70 mg/dL and 1:6 had LDL-C <55 mg/dL. Each 10 mg/dL higher LDL-C value was associated with a 5% and 6% higher 5-year incidence of MACE and CV death, respectively. (TECOS, NCT00790205).