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Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes.
Lim, K, Chi, C, Chan, SY, Lim, SL, Ang, SM, Yoong, JS, Tsai, C, Wong, SR, Yew, TW, Tai, ES, et al
BMC public health. 2019;(1):1287
Abstract
BACKGROUND Gestational diabetes (GDM) is a known risk factor for type 2 diabetes mellitus (T2DM), and women with a history of GDM have a 7-fold increased risk of developing the disease. Achieving a healthy weight post-delivery is key in reducing the risk of future diabetes in these women. The aim of this trial is to investigate the use of an interactive smartphone application (APP) to restore women to optimal weight following delivery. METHODS This will be an open-label randomized controlled trial. Two hundred women with gestational diabetes will be randomized to receive the intervention or standard care following delivery. Participants will be reviewed at 6 weeks and 4 months post-delivery. The intervention is an APP serving as a platform for weight, diet and physical activity tracking. The APP provides 3-5 min educational videos suggesting suitable lifestyle adjustments relevant to postnatal period such as breast feeding, diet and exercise. Lastly, the APP will allow real-time interaction between users and the team of dietitians, physiotherapists and occupational therapists to encourage restoration of optimal weight. Women in the control arm will be informed about the increased risk of developing T2DM and advised to maintain a healthy weight. Primary outcome measure is the restoration of participants' booking weight if booking BMI ≤ 23, or weight loss of at least 5% from booking weight if booking BMI > 23 over the 4 month period. Secondary outcome measures will assess serum metabolic and inflammatory markers, quality of life via questionnaires and cost-effectiveness of the intervention at each follow-up visit. DISCUSSION This will be the first randomised controlled trial investigating the use of a smartphone application for postpartum weight loss in women with gestational diabetes. The major ethnic groups in our study population represent the majority of ethnic groups in Asia, amongst which the prevalence of diabetes is high. If shown to be effective, this APP may be used in wider clinical settings to improve postpartum weight loss and reduce the risk of developing T2DM in these women. TRIAL REGISTRATION This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT03324737 .
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Effects of sodium-glucose cotransporter 2 inhibitors in addition to insulin therapy on cardiovascular risk factors in type 2 diabetes patients: A meta-analysis of randomized controlled trials.
Wu, B, Zheng, H, Gu, J, Guo, Y, Liu, Y, Wang, Y, Chen, F, Yang, A, Wang, J, Wang, H, et al
Journal of diabetes investigation. 2019;(2):446-457
Abstract
AIMS/INTRODUCTION In the present meta-analysis, we aimed to determine the effects of sodium-glucose cotransporter 2 inhibitor (SGLT-2i) in addition to insulin therapy on cardiovascular risk factors in type 2 diabetes patients. MATERIALS AND METHODS Randomized controlled trials were identified by searching the PubMed, Embase and Cochrane Library databases published before September 2017. The intervention group received SGLT-2i as add-on treatment to insulin therapy, and the control group received placebos in addition to insulin. We assessed pooled data, including weighted mean differences and 95% confidence intervals (CIs) using a random-effects model. RESULTS A total of 10 randomized controlled trials (n = 5,159) were eligible. The weighted mean differences for systolic blood pressure and diastolic blood pressure were -3.17 mmHg (95% CI -4.53, -1.80, I2 = 0%) and -1.60 mmHg (95% CI -2.52, -0.69, I2 = 0%) in the intervention groups. Glycosylated hemoglobin, fasting plasma glucose, postprandial glucose and daily insulin were also lower in the intervention groups, with relative weighted mean differences of -0.49% (95% CI -0.71, -0.28%, I2 = 92%), -1.10 mmol/L (95% CI -1.69, -0.51 mmol/L, I2 = 84%), -3.63 mmol/L (95% CI -4.36, -2.89, I2 = 0%) and -5.42 IU/day (95% CI -8.12, -2.72, I2 = 93%). The transformations of uric acid and bodyweight were -26.16 μmol/L (95% CI -42.14, -10.17, I2 = 80%) and -2.13 kg (95% CI -2.66, -1.60, I2 = 83%). The relative risk of hypoglycemia was 1.09 (95% CI 1.02, 1.17, P < 0.01). The relative risks of urinary tract and genital infection were 1.29 (95% CI 1.03, 1.62, P = 0.03) and 5.25 (95% CI 3.55, 7.74, P < 0.01). CONCLUSIONS The results showed that in the intervention group, greater reductions were achieved for blood pressure, glucose control, uric acid and bodyweight. This treatment regimen might therefore provide beneficial effects on the occurrence and development of cardiovascular events.
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Neurovascular decoupling in type 2 diabetes mellitus without mild cognitive impairment: Potential biomarker for early cognitive impairment.
Yu, Y, Yan, LF, Sun, Q, Hu, B, Zhang, J, Yang, Y, Dai, YJ, Cui, WX, Xiu, SJ, Hu, YC, et al
NeuroImage. 2019;:644-658
Abstract
Type 2 diabetes mellitus (T2DM) is a significant risk factor for mild cognitive impairment (MCI) and the acceleration of MCI to dementia. The high glucose level induce disturbance of neurovascular (NV) coupling is suggested to be one potential mechanism, however, the neuroimaging evidence is still lacking. To assess the NV decoupling pattern in early diabetic status, 33 T2DM without MCI patients and 33 healthy control subjects were prospectively enrolled. Then, they underwent resting state functional MRI and arterial spin labeling imaging to explore the hub-based networks and to estimate the coupling of voxel-wise cerebral blood flow (CBF)-degree centrality (DC), CBF-mean amplitude of low-frequency fluctuation (mALFF) and CBF- mean regional homogeneity (mReHo). We further evaluated the relationship between NV coupling pattern and cognitive performance (false discovery rate corrected). T2DM without MCI patients displayed significant decrease in the absolute CBF-mALFF, CBF-mReHo coupling of CBFnetwork and in the CBF-DC coupling of DCnetwork. Besides, networks which involved CBF and DC hubs mainly located in the default mode network (DMN). Furthermore, less severe disease and better cognitive performance in T2DM patients were significantly correlated with higher coupling of CBF-DC, CBF-mALFF or CBF-mReHo, especially for the cognitive dimensions of general function and executive function. Thus, coupling of CBF-DC, CBF-mALFF and CBF-mReHo may serve as promising indicators to reflect NV coupling state and to explain the T2DM related early cognitive impairment.
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Role of diet in type 2 diabetes incidence: umbrella review of meta-analyses of prospective observational studies.
Neuenschwander, M, Ballon, A, Weber, KS, Norat, T, Aune, D, Schwingshackl, L, Schlesinger, S
BMJ (Clinical research ed.). 2019;:l2368
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OBJECTIVE To summarise the evidence of associations between dietary factors and incidence of type 2 diabetes and to evaluate the strength and validity of these associations. DESIGN Umbrella review of systematic reviews with meta-analyses of prospective observational studies. DATA SOURCES PubMed, Web of Science, and Embase, searched up to August 2018. ELIGIBILITY CRITERIA Systematic reviews with meta-analyses reporting summary risk estimates for the associations between incidence of type 2 diabetes and dietary behaviours or diet quality indices, food groups, foods, beverages, alcoholic beverages, macronutrients, and micronutrients. RESULTS 53 publications were included, with 153 adjusted summary hazard ratios on dietary behaviours or diet quality indices (n=12), food groups and foods (n=56), beverages (n=10), alcoholic beverages (n=12), macronutrients (n=32), and micronutrients (n=31), regarding incidence of type 2 diabetes. Methodological quality was high for 75% (n=115) of meta-analyses, moderate for 23% (n=35), and low for 2% (n=3). Quality of evidence was rated high for an inverse association for type 2 diabetes incidence with increased intake of whole grains (for an increment of 30 g/day, adjusted summary hazard ratio 0.87 (95% confidence interval 0.82 to 0.93)) and cereal fibre (for an increment of 10 g/day, 0.75 (0.65 to 0.86)), as well as for moderate intake of total alcohol (for an intake of 12-24 g/day v no consumption, 0.75 (0.67 to 0.83)). Quality of evidence was also high for the association for increased incidence of type 2 diabetes with higher intake of red meat (for an increment of 100 g/day, 1.17 (1.08 to 1.26)), processed meat (for an increment of 50 g/day, 1.37 (1.22 to 1.54)), bacon (per two slices/day, 2.07 (1.40 to 3.05)), and sugar sweetened beverages (for an increase of one serving/day, 1.26 (1.11 to 1.43)). CONCLUSIONS Overall, the association between dietary factors and type 2 diabetes has been extensively studied, but few of the associations were graded as high quality of evidence. Further factors are likely to be important in type 2 diabetes prevention; thus, more well conducted research, with more detailed assessment of diet, is needed. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42018088106.
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High serum osteopontin levels are associated with prevalent fractures and worse lipid profile in post-menopausal women with type 2 diabetes.
Filardi, T, Carnevale, V, Massoud, R, Russo, C, Nieddu, L, Tavaglione, F, Turinese, I, Lenzi, A, Romagnoli, E, Morano, S
Journal of endocrinological investigation. 2019;(3):295-301
Abstract
PURPOSE Patients with type 2 diabetes (T2DM) have increased fracture risk. Osteopontin (OPN) is a protein involved in bone remodeling and inflammation. The aim of this study was to evaluate the association of OPN with fracture prevalence and with metabolic parameters in post-menopausal women with T2DM. METHODS Sixty-four post-menopausal women with T2DM (age 67.0 ± 7.8 years, diabetes duration 8.9 ± 6.7 years), enrolled in a previous study, were followed up (3.6 ± 0.9 years). Previous fragility fractures were recorded. The FRAX score (without BMD) was calculated and biochemical parameters (plasma glucose, HbA1c, lipid profile and renal function) were assessed. Serum 25OH-vitamin D, calcium, PTH and OPN were evaluated at baseline. The association between OPN and fracture prevalence at baseline was evaluated by a logistic model. RESULTS OPN levels were higher in patients with previous fractures (n.25) than in patients without previous fractures at baseline (n.39) (p = 0.006). The odds of having fractures at baseline increased by 6.7 (1.9-31.4, 95% CI, p = 0.007) for each increase of 1 ng/ml in OPN levels, after adjustment for vitamin D and HbA1c levels. Fracture incidence was 4.7%. Higher OPN associated with a decrease in HDL-cholesterol (p = 0.048), after adjustment for age, basal HDL-cholesterol, basal and follow-up HbA1c and follow-up duration. 25OH-vitamin D associated with an increase in FRAX-estimated probability of hip fracture at follow-up (p = 0.029), after adjustment for age, 25OH-vitamin D and time. CONCLUSIONS In post-menopausal women with T2DM, OPN might be a useful marker of fracture and worse lipid profile.
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Elevated serum OxLDL is associated with progression of type 2 Diabetes Mellitus to diabetic retinopathy.
Kuppan, K, Mohanlal, J, Mohammad, AM, Babu, KA, Sen, P, Undurti, ND, Natarajan, V, Narayanasamy, A
Experimental eye research. 2019;:107668
Abstract
Hyperlipidemia is associated with the progression of diabetic retinopathy (DR). Paraoxonase 1 (PON1), an esterase is known to prevent systemic LDL oxidation. This study assessed if serum oxLDL is associated with the progression of Type 2 DM to DR. This study is part of a three-year hospital based prospective study where 87 subjects were recruited. This included T2DM without DR (n = 22); Non-Proliferative (NPDR) (n = 21) and Proliferative DR (PDR) (n = 22) along with age/sex matched controls (n = 22). Serum oxLDL-Ab was estimated by ELISA. Serum PON esterase activity and plasma Malondialdehyde (MDA) level were estimated by spectrophotometry and the serum Advanced Glycation End products (AGE) level by spectroflourimetry. The systemic levels of oxLDL, AGE and MDA were increased with the progression of T2DM without DR to DR as seen by ANOVA (P < 0.05). Serum oxLDL-Ab levels showed a positive correlation to total cholesterol (P = 0.04) as evaluated in the DR group. Statin intake was found to lower PON esterase activity (P < 0.05). Based on this pilot study, it is proposed that elevated serum oxLDL should be validated in larger cohort studies to ensure it could be potential risk factor for the progression of T2DM to DR.
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Effects of SGLT2 inhibitors on fractures and bone mineral density in type 2 diabetes: An updated meta-analysis.
Li, X, Li, T, Cheng, Y, Lu, Y, Xue, M, Xu, L, Liu, X, Yu, X, Sun, B, Chen, L
Diabetes/metabolism research and reviews. 2019;(7):e3170
Abstract
BACKGROUND The aim of the study is to update and determine the effects of sodium glucose cotransporter 2 (SGLT2) inhibitor therapy on fracture and bone mineral density (BMD) in patients with type 2 diabetes mellitus (T2DM). METHODS We identified 27 eligible randomized controlled trials (RCTs) that compared the efficacy and safety of SGLT2 inhibitors to a placebo in 20 895 T2DM participants, with an average duration of 64.22 weeks. The relative risk (RR) of bone fracture and weighted mean difference (WMD) of changes in the BMD from baseline were determined to evaluate the risk of fracture. The degree of heterogeneity was evaluated by the I2 statistic, and publication bias was estimated using a funnel plot and Egger test. RESULTS The pooled RR was 1.02 (95% CI [0.81, 1.28]) with low heterogeneity, indicating that SGLT2 inhibitor treatment was not correlated with a higher risk of fracture. Additionally, no increased risk was found for patients with different ages, sexes, and levels of HbA1c and some biochemical indicators. Three trials with 1303 patients reported a change in the BMD from baseline. SGLT2 inhibitor treatment did not decrease the BMD at four skeletal sites (lumbar spine, femoral neck, total hip, and distal forearm), and the overall WMD was 0.08 (95% CI [-0.09, 0.26]). No significant publication bias was detected. CONCLUSIONS No increased risk for bone fracture was detected in patients with T2DM treated with SGLT2 inhibitors in this meta-analysis. SGLT2 inhibitor therapy did not appear to affect bone health, but more long-term detailed data are needed to validate this conclusion.
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Lilly Insulin Glargine Versus Lantus® in Type 2 Diabetes Mellitus Patients: India and East Asia Subpopulation Analyses of the ELEMENT 5 Study.
Mohan, V, Ahn, KJ, Cho, YM, Sahay, RK, Huang, CN, Kalra, S, Chadha, M, Bhattacharya, I, Kim, SY, Spaepen, E
Clinical drug investigation. 2019;(8):745-756
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BACKGROUND AND OBJECTIVES Lilly insulin glargine (LY IGlar; Basaglar®) and the reference insulin glargine product (IGlar; Lantus®) are basal insulin glargine analogs with identical amino acid sequence and similar pharmacological profiles. ELEMENT 5, a Phase 3, prospective, randomized, multinational, two-arm, active-controlled, open-label, parallel-design study in type 2 diabetes mellitus (T2DM) patients (N = 493) showed similar efficacy and safety profiles with LY IGlar and IGlar. This study reports results from India (N = 100) and East Asia (N = 134) subpopulations. METHODS Patients from India and East Asia (Korea and Taiwan) with T2DM who were insulin naïve (glycated hemoglobin (HbA1c) ≥ 7.0% and ≤ 11.0%) or on basal insulin (HbA1c ≤ 11.0%) were randomized to receive LY IGlar or IGlar along with oral antihyperglycemic medications (OAMs) for 24 weeks. Patients were instructed to self-titrate from the starting dose by 1 unit/day until fasting blood glucose (FBG) ≤ 5.6 mmol/L (100 mg/dL) was achieved. The key outcome was HbA1c change from baseline to Week 24. RESULTS Within-group least-squares mean (LSM) decrease (baseline to Week 24) in HbA1c was similar between treatments. The upper limit of confidence interval (CI) for treatment difference was below the defined 0.4% noninferiority margin in India (LY IGlar: - 0.83%; IGlar: - 0.62%; difference [95% CI] - 0.21 [- 0.70, 0.28]) and East Asia (LY IGlar: - 1.28%; IGlar: - 1.26%; difference [95% CI] - 0.02 [- 0.34, 0.30]) subpopulations. Results of other efficacy and safety endpoints at Week 24 were similar between treatments in both subpopulations. LSM self-monitored FBG levels were similar between treatments at all visits in both subpopulations except at Week 24 in the India subpopulation (LY IGlar: 5.65 [0.10] mmol/L or 101.8 [1.86] mg/dL; IGlar: 5.18 [0.10] mmol/L or 93.3 [1.75] mg/dL; p = 0.002). CONCLUSION Efficacy and safety profiles of LY IGlar and IGlar, in combination with OAMs, were similar in India and East Asia subpopulations. This was consistent with the ELEMENT 5 total population. CLINICAL TRIAL REGISTRATION NCT02302716.
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Bioactive compounds in plant materials for the prevention of diabetesand obesity.
Kato, E
Bioscience, biotechnology, and biochemistry. 2019;(6):975-985
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Abstract
Plant materials have been widely studied for their preventive and therapeutic effects for type 2 diabetes mellitus (T2DM) and obesity. The effect of a plant material arises from its constituents, and the study of these bioactive compounds is important to achieve a deeper understanding of its effect at the molecular level. In particular, the study of the effects of such bioactive compounds on various biological processes, from digestion to cellular responses, is required to fully understand the overall effects of plant materials in these health contexts. In this review, I summarize the bioactive compounds we have recently studied in our research group that target digestive enzymes, dipeptidyl peptidase-4, myocyte glucose uptake, and lipid accumulation in adipocytes. Abbreviations: AC: adenylyl cyclase; AMPK AMP-activated protein kinase; βAR: β-adrenergic receptor; CA: catecholamine; cAMP: cyclic adenosine monophosphate; cGMP: cyclic guanosine monophosphate; DPP-4: dipeptidyl peptidase-4; ERK: extracellular signal-regulated kinase; GC: guanylyl cyclase; GH: growth hormone; GLP-1: glucagon-like peptide-1; GLUT glucose transporter; HSL: hormone-sensitive lipase; IR: insulin receptor; IRS: insulin receptor substrate; MAPK mitogen-activated protein kinase; MEK: MAPK/ERK kinase; MG: maltase-glucoamylase; NP: natriuretic peptide; NPR: natriuretic peptide receptor; mTORC2: mechanistic target of rapamycin complex-2; PC: proanthocyanidin; PI3K: phosphoinositide 3-kinase; PKA: cAMP-dependent protein kinase; PKB (AKT): protein kinase B; PKG: cGMP-dependent protein kinase; PPARγ: peroxisome proliferator-activated receptor-γ; SGLT1: sodium-dependent glucose transporter 1; SI: sucrase-isomaltase; T2DM: type 2 diabetes mellitus; TNFα: tumor necrosis factor-α.
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Epicardial adipose tissue thickness and type 2 diabetes risk according to the FINDRISC modified for Latin America.
Lima-Martínez, MM, Colmenares, L, Campanelli, Y, Paoli, M, Rodney, M, Santos, RD, Iacobellis, G
Clinica e investigacion en arteriosclerosis : publicacion oficial de la Sociedad Espanola de Arteriosclerosis. 2019;(1):15-22
Abstract
BACKGROUND The Finnish Diabetes Risk Score (FINDRISC) is a tool to predict 10-year risk of type 2 diabetes mellitus (T2DM), and visceral adiposity is associated with higher cardio-metabolic risk. The objective of the study was to assess the relationship of epicardial adipose tissue (EAT) thickness with T2DM risk according to the FINDRISC tool. METHODS The study was conducted in Ciudad Bolívar, Venezuela, and included 55 subjects of whom 37 (67.3%) were women and 18 (32.7%) men with ages between 18 and 75 years. A record was made of weight, height, body mass index (BMI), waist circumference (WC), fasting glucose, baseline insulin, plasma lipids, Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), and EAT thickness. The FINDRISC tool, with WC cut-off points modified for Latin America (LA-FINDRISC) was used. RESULTS BMI, WC, plasma insulin concentration, HOMA-IR index, and EAT thickness were higher (P<0.0001) in the high-risk group compared to subjects in the low-moderate risk group according to the LA-FINDRISC. LA-FINDRISC was positively correlated with BMI (r=0.513; P=0.0001), WC (r=0.524; P=0.0001), fasting blood glucose (r=0.396; P=0.003); baseline plasma insulin (r=0.483; P=0.0001); HOMA-IR index (r=0.545; P=.0.0001); and EAT thickness (r=0.702; P=0.0001). The multivariate regression analysis showed that fasting blood glucose (P=0.023) and EAT thickness (P=0.007) remained independently associated with high T2DM risk. CONCLUSIONS LA-FINDRISC was associated with EAT thickness and insulin resistance markers. Both were independently and directly associated with high risk for diabetes in the LA-FINDRISC category.