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Patient-centered communication and shared decision making to reduce HbA1c levels of patients with poorly controlled type 2 diabetes mellitus - results of the cluster-randomized controlled DEBATE trial.
Wollny, A, Altiner, A, Daubmann, A, Drewelow, E, Helbig, C, Löscher, S, Pentzek, M, Santos, S, Wegscheider, K, Wilm, S, et al
BMC family practice. 2019;(1):87
Abstract
BACKGROUND Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c. METHODS The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6-8 months (T1), 12-14 months (T2), 18-20 months (T3), and 24-26 months (T4) after baseline. Main outcome measure is the level of HbA1c. RESULTS In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (- 0.67% (95% CI: - 0.80,-0.54%; p < 0.0001) and - 0.64% (95% CI: - 0.78, - 0.51%; p < 0.0001), respectively). However, there was no statistically significant difference between both groups. CONCLUSIONS Although the DEBATE trial was not able to confirm effectiveness of the intervention tested compared to care as usual, the results suggest that patients with poorly controlled type 2 diabetes are able to improve their blood glucose levels. This finding may encourage physicians to stay on task to regularly approach this cohort of patients. TRIAL REGISTRATION The trial was registered at ISRCTN registry under the reference ISRCTN70713571 .
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Multidisciplinary Challenges in Mastocytosis and How to Address with Personalized Medicine Approaches.
Valent, P, Akin, C, Gleixner, KV, Sperr, WR, Reiter, A, Arock, M, Triggiani, M
International journal of molecular sciences. 2019;(12)
Abstract
Mastocytosis is a hematopoietic neoplasm defined by abnormal expansion and focal accumulation of clonal tissue mast cells in various organ-systems. The disease exhibits a complex pathology and an equally complex clinical behavior. The classification of the World Health Organization (WHO) divides mastocytosis into cutaneous forms, systemic variants, and localized mast cell tumors. In >80% of patients with systemic mastocytosis (SM), a somatic point mutation in KIT at codon 816 is found. Whereas patients with indolent forms of the disease have a normal or near-normal life expectancy, patients with advanced mast cell neoplasms, including aggressive SM and mast cell leukemia, have a poor prognosis with short survival times. In a majority of these patients, multiple somatic mutations and/or an associated hematologic neoplasm, such as a myeloid leukemia, may be detected. Independent of the category of mastocytosis and the serum tryptase level, patients may suffer from mediator-related symptoms and/or osteopathy. Depending on the presence of co-morbidities, the symptomatology in such patients may be mild, severe or even life-threatening. Most relevant co-morbidities in such patients are IgE-dependent allergies, psychiatric, psychological or mental problems, and vitamin D deficiency. The diagnosis and management of mastocytosis is an emerging challenge in clinical practice and requires vast knowledge, a multidisciplinary approach, and personalized medicine procedures. In this article, the current knowledge about mastocytosis is reviewed with special emphasis on the multidisciplinary aspects of the disease and related challenges in daily practice.
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Current understanding of gut microbiota alterations and related therapeutic intervention strategies in heart failure.
Chen, X, Li, HY, Hu, XM, Zhang, Y, Zhang, SY
Chinese medical journal. 2019;(15):1843-1855
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Abstract
OBJECTIVE The purpose of this review is to stress the complicated interactions between the microbiota and the development of heart failure. Moreover, the feasibility of modulating intestinal microbes and metabolites as novel therapeutic strategies is discussed. DATA SOURCES This study was based on data obtained from PubMed up to March 31, 2019. Articles were selected using the following search terms: "gut microbiota," "heart failure," "trimethylamine N-oxide (TMAO)," "short-chain fatty acid (SCFA)," "bile acid," "uremic toxin," "treatment," "diet," "probiotic," "prebiotic," "antibiotic," and "fecal microbiota transplantation." RESULTS Accumulated evidence has revealed that the composition of the gut microbiota varies obviously in people with heart failure compared to those with healthy status. Altered gut microbial communities contribute to heart failure through bacterial translocation or affecting multiple metabolic pathways, including the trimethylamine/TMAO, SCFA, bile acid, and uremic toxin pathways. Meanwhile, modulation of the gut microbiota through diet, pre/probiotics, fecal transplantation, and microbial enzyme inhibitors has become a potential therapeutic approach for many metabolic disorders. Specifically, a few studies have focused on the cardioprotective effects of probiotics on heart failure. CONCLUSIONS The composition of the gut microbiota in people with heart failure is different from those with healthy status. A reduction in SCFA-producing bacteria in patients with heart failure might be a notable characteristic for patients with heart failure. Moreover, an increase in the microbial potential to produce TMAO and lipopolysaccharides is prominent. More researches focused on the mechanisms of microbial metabolites and the clinical application of multiple therapeutic interventions is necessarily required.
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Dietary assessment toolkits: an overview.
Dao, MC, Subar, AF, Warthon-Medina, M, Cade, JE, Burrows, T, Golley, RK, Forouhi, NG, Pearce, M, Holmes, BA
Public health nutrition. 2019;(3):404-418
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Abstract
OBJECTIVE A wide variety of methods are available to assess dietary intake, each one with different strengths and weaknesses. Researchers face multiple challenges when diet and nutrition need to be accurately assessed, particularly in the selection of the most appropriate dietary assessment method for their study. The goal of the current collaborative work is to present a collection of available resources for dietary assessment implementation.Design/Setting/ParticipantsAs a follow-up to the 9th International Conference on Diet and Physical Activity Methods held in 2015, developers of dietary assessment toolkits agreed to collaborate in the preparation of the present paper, which provides an overview of each toolkit. The toolkits presented include: the Diet, Anthropometry and Physical Activity Measurement Toolkit (DAPA; UK); the National Cancer Institute's (NCI) Dietary Assessment Primer (USA); the Nutritools website (UK); the Australasian Child and Adolescent Obesity Research Network (ACAORN) method selector (Australia); and the Danone Dietary Assessment Toolkit (DanoneDAT; France). An at-a-glance summary of features and comparison of the toolkits is provided. RESULTS The present review contains general background on dietary assessment, along with a summary of each of the included toolkits, a feature comparison table and direct links to each toolkit, all of which are freely available online. CONCLUSIONS This overview of dietary assessment toolkits provides comprehensive information to aid users in the selection and implementation of the most appropriate dietary assessment method, or combination of methods, with the goal of collecting the highest-quality dietary data possible.
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Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial.
Benhamou, PY, Franc, S, Reznik, Y, Thivolet, C, Schaepelynck, P, Renard, E, Guerci, B, Chaillous, L, Lukas-Croisier, C, Jeandidier, N, et al
The Lancet. Digital health. 2019;(1):e17-e25
Abstract
BACKGROUND Closed-loop insulin delivery systems are expected to become a standard treatment for patients with type 1 diabetes. We aimed to assess whether the Diabeloop Generation 1 (DBLG1) hybrid closed-loop artificial pancreas system improved glucose control compared with sensor-assisted pump therapy. METHODS In this multicentre, open-label, randomised, crossover trial, we recruited adults (aged ≥18 years) with at least a 2 year history of type 1 diabetes, who had been treated with external insulin pump therapy for at least 6 months, had glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol), and preserved hypoglycaemia awareness. After a 2-week run-in period, patients were randomly assigned (1:1) with a web-based system in randomly permuted blocks of two, to receive insulin via the hybrid closed-loop system (DBLG1; using a machine-learning-based algorithm) or sensor-assisted pump therapy over 12 weeks of free living, followed by an 8-week washout period and then the other intervention for 12 weeks. The primary outcome was the proportion of time that the sensor glucose concentration was within the target range (3·9-10·0 mmol/L) during the 12 week study period. Efficacy analyses were done in the modified intention-to-treat population, which included all randomly assigned patients who completed both 12 week treatment periods. Safety analyses were done in all patients who were exposed to either of the two treatments at least once during the study. This trial is registered with ClinicalTrials.gov, number NCT02987556. FINDINGS Between March 3, 2017, and June 19, 2017, 71 patients were screened, and 68 eligible patients were randomly assigned to the DBLG1 group (n=33) or the sensor-assisted pump therapy group (n=35), of whom five dropped out in the washout period (n=1 pregnancy; n=4 withdrew consent). 63 patients completed both 12 week treatment periods and were included in the modified intention-to-treat analysis. The proportion of time that the glucose concentration was within the target range was significantly higher in the DBLG1 group (68·5% [SD 9·4] than the sensor-assisted pump group (59·4% [10·2]; mean difference 9·2% [95% CI 6·4 to 11·9]; p<0·0001). Five severe hypoglycaemic episodes occurred in the DBLG1 group and three episodes occurred in the sensor-assisted pump therapy group, which were associated with hardware malfunctions or human error. INTERPRETATION The DBLG1 system improves glucose control compared with sensor-assisted insulin pumps. This finding supports the use of closed-loop technology combined with appropriate health care organisation in adults with type 1 diabetes. FUNDING French Innovation Fund, Diabeloop.
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Therapeutic uses of Amaranthus caudatus L.
Jimoh, MO, Afolayan, AJ, Lewu, FB
Tropical biomedicine. 2019;(4):1038-1053
Abstract
The use of plants as therapy is not alien to man. Among plants that could offer novel choice to the limited therapeutic alternatives is Amaranthus caudatus. It is typically rich in bioactive compounds such as phenolic acids, lycopene, polyphenols, unsaturated fatty acids, glucosinolates, proteins, soluble peptides, flavonoids, squalene and betacarotene to say the least. As widely reported in the literature, its various capacities to fight diseases when ingested as food or medicine may not be unconnected to these bioactive compounds available in high concentrations. This current review, therefore, harmonized reports from scientific investigations that validated the use of A. caudatus for the treatment of various ailments such as Diabetes mellitus, cancer, malaria, hypercholesterolemia, atherosclerosis, helminthic and bacterial infections, inflammation, hepatic diseases and cardiovascular complications. With this, we hope to put in perspective, the key therapeutic options available in the plant.
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Iron in Neurodegeneration - Cause or Consequence?
Ndayisaba, A, Kaindlstorfer, C, Wenning, GK
Frontiers in neuroscience. 2019;:180
Abstract
Iron dyshomeostasis can cause neuronal damage to iron-sensitive brain regions. Neurodegeneration with brain iron accumulation reflects a group of disorders caused by iron overload in the basal ganglia. High iron levels and iron related pathogenic triggers have also been implicated in sporadic neurodegenerative diseases including Alzheimer's disease (AD), Parkinson's disease (PD), and multiple system atrophy (MSA). Iron-induced dyshomeostasis within vulnerable brain regions is still insufficiently understood. Here, we summarize the modes of action by which iron might act as primary or secondary disease trigger in neurodegenerative disorders. In addition, available treatment options targeting brain iron dysregulation and the use of iron as biomarker in prodromal stages are critically discussed to address the question of cause or consequence.
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EPA+DHA, but not ALA, Improved Lipids and Inflammation Status in Hypercholesterolemic Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.
Zhou, Q, Zhang, Z, Wang, P, Zhang, B, Chen, C, Zhang, C, Su, Y
Molecular nutrition & food research. 2019;(10):e1801157
Abstract
SCOPE To compare the effects of supplementary eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) versus α-linolenic acid (ALA) on lipid profiles, inflammatory status, and fatty acid composition of peripheral blood mononuclear cells (PBMCs) in hypercholesterolemic adults. METHODS AND RESULTS A randomized, controlled, double-blind trial is conducted to examine the effects of consumption of control oil, 4.2 g/d ALA, 7.2 g/d ALA, 1.8 g/d DHA+EPA, or 3.6 g/d EPA+DHA for 12 weeks on lipid profiles, fatty acid composition of PBMCs and in vitro production of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) by PBMCs in 123 subjects with hypercholesteremia. After the intervention, subjects who receive a low and high dose of DHA/EPA experience 11.99% and 15.78% decreases in triglycerides which is significantly different from that of the control group (p < 0.05). The in vitro study indicates that supplementation of high-dose DHA+EPA induces the greatest decrease of IL-6 production by PBMCs relative to other groups (p = 0.046). ALA intervention significantly increases the PBMCs composition of ALA but not EPA/DHA. CONCLUSION EPA+DHA, but not ALA, improves lipids and inflammation status in hypercholesterolemic adults. Supplementation of ALA does not increase the PBMCs composition of EPA/DHA in middle-aged to elderly Chinese.
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Azathioprine and 6-mercaptopurine for maintenance of surgically-induced remission in Crohn's disease.
Gjuladin-Hellon, T, Iheozor-Ejiofor, Z, Gordon, M, Akobeng, AK
The Cochrane database of systematic reviews. 2019;(8):CD010233
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Abstract
BACKGROUND Crohn's disease (CD) is a chronic relapsing inflammatory condition and maintenance of remission is a major issue as many patients fail to achieve remission with medical management and require surgical interventions. Purine analogues such as azathioprine (AZA) and 6-mercaptopurine (6-MP) have been used to maintain surgically-induced remission in CD, but the effectiveness, tolerability and safety of these agents remains controversial. OBJECTIVES To assess the efficacy and safety of purine analogues (AZA and 6-MP) for maintenance of surgically-induced remission in CD. SEARCH METHODS We searched PubMed, MEDLINE, Embase, CENTRAL, and the Cochrane IBD Group Specialized Register from inception to 26 July 2018 (and from inception to 31 July 2019). In addition, we searched reference lists of all included studies and relevant reviews, conference proceedings and trials registers. SELECTION CRITERIA Randomised controlled trials (RCTs) with a duration of at least three months that enrolled adults and children with surgically-induced remission of CD and compared AZA or 6-MP to no treatment, placebo or any other active intervention were considered for inclusion. DATA COLLECTION AND ANALYSIS Two authors independently assessed trial eligibility, extracted data, assessed the risk of bias and assessed the certainty of the evidence using GRADE. The primary outcome was clinical relapse. Secondary outcomes included endoscopic relapse, radiologic and surgical relapse, adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs and health-related quality of life. MAIN RESULTS Ten RCTs with a total of 928 participants were included. Study participants were adults recruited from university clinics and gastroenterology hospitals who received interventions post-surgery for a duration between 12 to 36 months. Most study participants were recruited less than three months after surgery in all except one study where participants were recruited between 6 to 24 months post-surgery. One study was rated as low risk of bias, six studies were rated high risk of bias and three were rated unclear risk of bias.There was moderate certainty evidence that purine analogues are more efficient for preventing clinical relapse than placebo. At 12 to 36 months, 51% (109/215) of AZA/6-MP participants relapsed compared to 64% (124/193) of placebo participants (RR 0.79; 95% CI 0.67 to 0.92; 408 participants; 3 studies; I² = 0%; moderate certainty evidence). The certainty of the evidence regarding the efficacy of AZA or 6-MP for maintaining postoperative clinical remission compared to 5-ASA compounds was low. At 12 to 24 months , 64% (113/177) of purine analogue participants relapsed compared to 59% (101/170) of 5-ASA participants (RR 1.05; 95% CI 0.89 to 1.24; 347 participants; 4 studies; I² = 8%; low certainty evidence). The certainty of evidence that purine analogues are inferior for preventing postsurgical clinical relapse compared to tumour necrosis factor alpha agents (anti-TNF-α) was very low. At 12 to 24 months, 43% (29/67) of AZA participants relapsed compared to 14% (10/72) of anti-TNF-α participants (RR 2.89; 95% CI 1.50 to 5.57; 139 participants; 3 studies; I² = 0%; very low certainty evidence).The effect of purine analogues compounds on AEs compared to placebo or any active treatment was uncertain, as the quality of evidence ranged from very low to low. After 12 to 24 months, 14% (12/87) of purine analogue participants experienced an AE compared to 10% (8/81) of placebo participants (RR 1.36; 95% CI 0.57 to 3.27; 168 participants; 2 studies; I² = 0%; low certainty evidence). The effect of purine analogues on AEs compared to 5-ASA agents was uncertain. After 12 to 24 months, 41% (73/176) of purine analogue participants had an AE compared to 47% (81/171) of 5-ASA participants (RR 0.89; 95% CI 0.74 to 1.07; 346 participants; 4 studies; I² = 15%; low certainty evidence). The effect of purine analogues on AEs in comparison to anti TNF-α agents was uncertain. At 12 to 24 months, 57% (32/56) of AZA participants had an AE compared to 51% (31/61) of anti-TNF-α participants (RR 1.13; 95% CI 0.83 to 1.53; 117 participants; 2 studies; I² = 0%; low certainty evidence). Purine analogue participants were more like than 5-ASA participants to have a SAE (RR 3.39, 95% CI 1.26 to 9.13, 311 participants; 3 studies; I² = 9%; very low certainty evidence), or to withdraw due to an AE (RR 2.21, 95% CI 1.28 to 3.81; 425 participants; 5 studies; I² = 0%; low certainty evidence). Commonly reported AEs across all studies included leucopenia, arthralgia, abdominal pain or severe epigastric intolerance, elevated liver enzymes, nausea and vomiting, pancreatitis, anaemia, nasopharyngitis and flatulence. AUTHORS' CONCLUSIONS Moderate certainty evidence suggests that AZA and 6-MP may be superior to placebo for maintenance of surgically-induced remission in participants with CD. There was no clear difference in the number of clinical relapses when purine analogues were compared with 5-ASA agents, however this is based on low certainty evidence. There was very low certainty evidence that AZA and 6-MP are more likely to result in more serious adverse events (SAEs) and withdrawals due to an AE (low certainty) when compared to 5-ASA agents. Very low certainty evidence suggests that purine analogues may be inferior to anti-TNF-α agents, however, no firm conclusions can be drawn. Further research investigating the efficacy and safety of AZA and 6-MP in comparison to other active medications in surgically-induced remission of CD is warranted.
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Role of Diabetes Education Program in Controlling Posttransplant Diabetes in a Recent Renal Transplant Bodybuilder: Case Report and Review of the Literature.
Othman, N, Gheith, O, Al-Otaibi, T, Abdou, H, Halim, MA, Mahmoud, T, Nair, P, Yagan, J, Maher, A, Dahab, M, et al
Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation. 2019;(Suppl 1):169-171
Abstract
Posttransplant diabetes is a common complication of solid-organ transplantation. We present the possible role of diabetes education in improvement of posttransplant diabetes in a 36-year-old bodybuilder who was a kidney transplant recipient. The patient had been abusing some medications to help in bodybuilding. He underwent living unrelated-donor renal transplant with thymoglobulin induction and was maintained on steroids, tacrolimus, and mycophenolate mofetil. Posttransplant diabetes was confirmed by blood tests. His blood sugar was partially controlled by 3 oral agents. The patient participated in our structured diabetes education program. This program was created to cover different items related to diabetes control, including diet, proper exercise, blood sugar monitoring, sick day management, and pathophysiologic roles of diabetes medications. Within 4 months of participation in this program, the patient's blood sugar became well controlled and his diabetes medications started to be minimized. He presently has stable graft function with hemoglobin A1c level around 5.6% on only diet management. Bodybuilders are at risk of deterioration of their kidney function. A proper diabetes education program is recommended to help renal transplant recipients with early posttransplant diabetes mellitus to control their disease. Success requires close evaluation and a multidisciplinary approach.