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Estimated glucose disposal rate as a candidate biomarker for thrombotic biomarkers in T1D: a pooled analysis.
O'Mahoney, LL, Kietsiriroje, N, Pearson, S, West, DJ, Holmes, M, Ajjan, RA, Campbell, MD
Journal of endocrinological investigation. 2021;(11):2417-2426
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Abstract
PURPOSE To determine the utility of estimated glucose disposal rate (eGDR) as a candidate biomarker for thrombotic biomarkers in patients with type 1 diabetes (T1D). METHODS We reanalysed baseline pretreatment data in a subset of patients with T1D from two previous RCTs, consisting of a panel of thrombotic markers, including fibrinogen, tissue factor (TF) activity, and plasminogen-activator inhibitor (PAI)-1, and TNFα, and clinical factors (age, T1D duration, HbA1c, insulin requirements, BMI, blood pressure, and eGDR). We employed univariate linear regression models to investigate associations between clinical parameters and eGDR with thrombotic biomarkers. RESULTS Thirty-two patients were included [mean ± SD age 31 ± 7 years, HbA1c of 58 ± 9 mmol/mol (7.5 ± 0.8%), eGDR 7.73 ± 2.61]. eGDR negatively associated with fibrinogen (P < 0.001), PAI-1 concentrations (P = 0.005), and TF activity (P = 0.020), but not TNFα levels (P = 0.881). We identified 2 clusters of patients displaying significantly different characteristics; 56% (n = 18) were categorised as 'higher-risk', eliciting significantly higher fibrinogen (+ 1514 ± 594 μg/mL; P < 0.001), TF activity (+ 59.23 ± 9.42 pmol/mL; P < 0.001), and PAI-1 (+ 8.48 ± 1.58 pmol/dL; P < 0.001), HbA1c concentrations (+ 14.20 ± 1.04 mmol/mol; P < 0.001), age (+ 7 ± 3 years; P < 0.001), duration of diabetes (15 ± 2 years; P < 0.001), BMI (+ 7.66 ± 2.61 kg/m2; P < 0.001), and lower mean eGDR (- 3.98 ± 1.07; P < 0.001). CONCLUSIONS Compared to BMI and insulin requirements, classical surrogates of insulin resistance, eGDR is a suitable and superior thrombotic risk indicator in T1D. TRIAL REGISTRATION ISRCTN4081115; registered 27 June 2017.
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Effect of soy milk consumption on glycemic status, blood pressure, fibrinogen and malondialdehyde in patients with non-alcoholic fatty liver disease: a randomized controlled trial.
Maleki, Z, Jazayeri, S, Eslami, O, Shidfar, F, Hosseini, AF, Agah, S, Norouzi, H
Complementary therapies in medicine. 2019;:44-50
Abstract
OBJECTIVE Diet plays a critical role in the management of non-alcoholic fatty liver disease (NAFLD). Studies on the NAFLD's experimental models have reported that soy had positive effects on the improvement of metabolic parameters. However, there is a lack of clinical trials regarding the efficacy of whole soy foods. Therefore, this study was conducted to determine the effect of soy milk on some of the metabolic characteristics in patients with NAFLD. METHODS Sixty-sex patients diagnosed with NAFLD were included in this randomized, parallel, controlled trial and were randomly assigned to either the soy milk or control group. Both groups received a 500-deficit calorie diet plan. Also, patients in the soy milk group consumed 240 ml/day soy milk for 8 weeks. Fasting blood sugar (FBS), serum insulin, HOMA-IR, HOMA-β%, and QUICKI as well as serum malondialdehyde (MDA), plasma fibrinogen, and blood pressure (BP) were measured at the beginning and end of the study. RESULTS After 8-weeks of intervention, soy milk group had a greater significant reduction in serum insulin(-3.44 ± 5.02 vs. -1.09 ± 3.77 μIU/ml, P = 0.04), HOMA-IR (-0.45±0.64 vs -0.14 ± 0.47, P = 0.03), systolic (-3.81±4.15 vs -1.48±2.93 mmHg, P = 0.01) and diastolic (-2.39±2.80 vs. -0.94±2.76 mmHg, P = 0.04) BP, and also, a significant increase in QUICKI (0.02± 0.032 vs. 0.008±0.018, P = 0.04) compared to the control group. While, changes in the FBS, HOMA-β%, fibrinogen, and MDA were not significantly different between the study groups. CONCLUSION A low-calorie diet containing soy milk had beneficial effects on serum insulin, HOMA-IR, QUICKI, and BP in patients with NAFLD.
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Ospemifene's effects on lipids and coagulation factors: a post hoc analysis of phase 2 and 3 clinical trial data.
Archer, DF, Altomare, C, Jiang, W, Cort, S
Menopause (New York, N.Y.). 2017;(10):1167-1174
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Abstract
OBJECTIVE To evaluate the effect of ospemifene 60 mg on the lipid and coagulation parameters of postmenopausal women using data from five phase 2 and 3 clinical trials. METHODS Data for lipids and coagulation factors for 2,166 postmenopausal women were pooled from five randomized, placebo-controlled studies. Lipid and coagulation parameters included in this analysis were total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, activated partial thromboplastin time (aPTT), fibrinogen, antithrombin antigen, protein C Ag, and protein S Ag free. RESULTS Mean percent changes in HDL and LDL were significantly greater with ospemifene versus placebo at month 3 (HDL: 4.4% vs 0.2%; LDL: -5.2% vs 2.4%), month 6 (HDL: 5.1% vs 1.5%; LDL: -6.7% vs 2.4%), and month 12 (HDL: 2.3% vs -1.9%; LDL: -7.0% vs -2.1%; P < 0.05, for all comparisons). Ospemifene significantly reduced total cholesterol at 6 months (-1.8% vs 1.6%; P = 0.0345 versus placebo), and changes in triglycerides with ospemifene were similar to placebo at all three time points. In subgroup analyses based on age, body mass index, and baseline triglyceride level, ospemifene increased HDL and decreased LDL, but had no significant effect on total cholesterol and triglycerides relative to placebo. Ospemifene significantly improved fibrinogen and protein C antigen levels relative to placebo at months 3 (-8.7% vs -0.8% and -2.7% vs 0.5%, respectively), 6 (-6.0% vs 6.7% and -3.6 vs 8.0%), and 12 (-8.7% vs 7.3% and -4.5% vs 6.6%; P < 0.01, for all). The levels of all coagulation factors remained within the normal range throughout the studies. CONCLUSION Ospemifene 60 mg does not have a detrimental effect on lipid and coagulation parameters of postmenopausal women with up to 12 months of use.
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The effects of alcohol on ambulatory blood pressure and other cardiovascular risk factors in type 2 diabetes: a randomized intervention.
Mori, TA, Burke, V, Zilkens, RR, Hodgson, JM, Beilin, LJ, Puddey, IB
Journal of hypertension. 2016;(3):421-8; discussion 428
Abstract
OBJECTIVE Although prospective studies suggest light-to-moderate chronic alcohol intake protects against coronary artery disease in type 2 diabetic patients, the balance of effects on individual cardiovascular risk factors needs further assessment. We examined the effects of alcohol consumption on 24-h ambulatory blood pressure (BP) and heart rate (HR), high-density lipoprotein cholesterol, fibrinogen, C-reactive protein, homocysteine, and glycaemic control in well controlled type 2 diabetes. METHODS Twenty-four participants aged 49-66 year were randomized to a three-period crossover study with women drinking red wine 230 ml/day (∼24 g alcohol/day) and men drinking red wine 300 ml/day (∼31 g alcohol/day), or equivalent volumes of dealcoholized red wine (DRW) or water, each for 4 weeks. Ambulatory BP and HR were monitored every 30 min for 24 h at the end of each period. Home blood glucose monitoring was carried out twice weekly throughout. RESULTS Red wine increased awake SBP and DBP relative to water by 2.5 ± 1.2 /1.9 ± 0.7 mmHg (P = 0.033, P = 0.008, respectively), with a similar nonsignificant trend relative to DRW. Asleep DBP fell with red wine relative to DRW (2.0 ± 0.8 mmHg, P = 0.016) with a similar nonsignificant trend relative to water. Red wine increased 24-h, awake and asleep HR relative to water and DRW. Relative to DRW, red wine did not affect glycaemic control or any other cardiovascular risk factor. CONCLUSION In well controlled type 2 diabetic individuals 24-31 g alcohol/day (∼2-3 standard drinks) raises awake BP and 24-h HR and lowers asleep BP but does not otherwise favourably or adversely modify cardiovascular risk factors.
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The predictive value of the prealbumin-to-fibrinogen ratio in patients with acute pancreatitis.
Yue, W, Liu, Y, Ding, W, Jiang, W, Huang, J, Zhang, J, Liu, J
International journal of clinical practice. 2015;(10):1121-8
Abstract
OBJECTIVE Early identification of severe acute pancreatitis (SAP) progression is important in acute pancreatitis (AP) treatment. The Ranson, APACHE II and CTSI systems are difficult to use and exhibit limited predictive value. Prealbumin and fibrinogen are acute phase reactants generally used to assess the nutritional statuses and coagulation functions of AP patients, respectively. Here, we explored the value of the combination of these two markers for evaluating AP severity and prognosis. METHODS One hundred and sixty-nine AP patients, including mild AP (MAP) (n = 101) and severe AP (SAP) patients (n = 68), were enrolled. Their Ranson, APACHE II and CTSI scores, routine laboratory test results, and prealbumin and fibrinogen levels were determined after admission. Multivariate regression analysis was performed to determine the independent predictors of AP severity. ROC curves were generated to determine the suitabilities of prealbumin and fibrinogen levels and the above-mentioned scores for SAP prediction. RESULTS The SAP patients exhibited higher scores, white blood cell counts, CRP and fibrinogen levels but lower calcium, prealbumin levels and prealbumin/fibrinogen ratio than the MAP patients (p < 0.05). The multivariate regression analysis demonstrated that the prealbumin/fibrinogen ratio was a good predictor of severity and outperformed CRP. The prealbumin/fibrinogen ratio was correlated with CRP, hospitalisation length and complication occurrence in SAP. The ROC curve analyses showed that the prealbumin/fibrinogen ratio exhibited superior sensitivity, specificity, PPV and NPV for SAP prediction over the scoring systems. With a cut-off of 31.70 mg/g, the sensitivity, specificity, PPV and NPV were 76.5%, 94.1%, 89.6% and 85.6%, respectively. CONCLUSIONS The prealbumin/fibrinogen ratio is a promising predictor of AP severity and prognosis.
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Effects of a novel therapeutic diet on liver enzymes and coagulating factors in patients with non-alcoholic fatty liver disease: A parallel randomized trial.
Kani, AH, Alavian, SM, Esmaillzadeh, A, Adibi, P, Azadbakht, L
Nutrition (Burbank, Los Angeles County, Calif.). 2014;(7-8):814-21
Abstract
OBJECTIVE There are several reports regarding the role of therapeutic diets for patients with non-alcoholic fatty liver disease (NAFLD). Therefore, the aim of this study was to determine the effects of a low-calorie, low-carbohydrate soy-containing diet on lipid profiles, liver enzymes, and coagulating factors in patients with NAFLD. METHOD This was a randomized parallel clinical trial involving 45 patients with NAFLD. The participants consumed three kinds of diets for 8 wk. Patients were randomly assigned to consume a low-calorie diet; a low-calorie, low-carbohydrate diet; or a low-calorie, low-carbohydrate soy-containing diet. Measurements were done according to the standard method. RESULTS Changes in weight were not significantly different in the three groups. The low-calorie, low-carbohydrate soy-containing diet could reduce alanine aminotransferase (-15.2 ± 12.1 versus -6.8 ± 4.6 in the low-calorie, low-carbohydrate diet, and -6.4 ± 4.4 IU/L in the low-calorie diet; P = 0.02) and serum fibrinogen levels (-49.1 ± 60.1 versus -12.9 ± 8.1 and -17.4 ± 8.4 g/L, respectively; P = 0.01). Reductions in aspartate aminotransferase were significantly higher in the low-calorie, low-carbohydrate soy-containing group. Changes in lipid profiles did not differ significantly between the groups. The soy-containing diet did reduce malondialdehyde more than the other diets (P = 0.01). CONCLUSION A low-calorie, low-carbohydrate soy-containing diet could have beneficial effects on liver enzymes, malondialdehyde, and serum fibrinogen levels in patients with NAFLD.
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A high intake of dietary fiber influences C-reactive protein and fibrinogen, but not glucose and lipid metabolism, in mildly hypercholesterolemic subjects.
Johansson-Persson, A, Ulmius, M, Cloetens, L, Karhu, T, Herzig, KH, Onning, G
European journal of nutrition. 2014;(1):39-48
Abstract
PURPOSE The aim of the study was to investigate how a diet high in dietary fiber, with several fiber sources included, modulates glucose and lipid metabolism and the inflammatory response in humans. METHODS Subjects (n = 25) aged 58.6 (1.1) years (mean and SD) with a BMI of 26.6 (0.5) kg/m(2) and a total cholesterol (TC) of 5.8 (0.1) mmol/L (mean and SEM) were given a high fiber (HF) and low fiber (LF) diet, in a randomized controlled 5-week crossover intervention, separated by a 3-week washout. The HF diet consisted of oat bran, rye bran, and sugar beet fiber incorporated into test food products; one bread roll, one ready meal, and two beverages consumed daily. Equivalent food products, without added fibers, were provided in the LF diet. RESULTS Total dietary fiber intake was 48.0 g and 30.2 g per day for the HF and LF diet, respectively. Significant reduction in C-reactive protein (CRP) was observed between the diets (P = 0.017) and a significant reduction in fibrinogen within the HF diet (P = 0.044). There were no significant effects in other measured circulating cytokines or in glucose, insulin, and lipid levels. CONCLUSIONS Our study suggests that a 5-week high dietary fiber intake of oat bran, rye bran, and sugar beet fiber might reduce the low-grade inflammatory response measured as CRP which could, together with reduced fibrinogen, help to prevent the risk of cardiovascular disease.
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Obesity-related increased γ' fibrinogen concentration in children and its reduction by a physical activity-based lifestyle intervention: a randomized controlled study.
Lovely, R, Hossain, J, Ramsey, JP, Komakula, V, George, D, Farrell, DH, Balagopal, PB
The Journal of pediatrics. 2013;(2):333-8
Abstract
OBJECTIVE To determine if elevated plasma γ'-fibrinogen, typically involved in the formation of fibrinolysis-resistant clots, confers an increased risk for cardiovascular disease (CVD) and thrombosis in children as it does in adults. Although obesity-related hyperfibrinogenemia is frequently reported in children, the role of γ' fibrinogen and its response to physical activity-based lifestyle are less clear in this population. STUDY DESIGN In a randomized controlled 3-month physical activity-based lifestyle intervention, γ' fibrinogen concentration was measured in 21 children (aged 14-18 years; Tanner stage > IV), including 15 in the obese group and 6 in the normal weight group, with body mass index percentiles for age and sex of >95 and <85, respectively. RESULTS The relationships between γ' fibrinogen and other risk factors for CVD, such as markers of insulin resistance and subclinical inflammation, along with body composition (as measured by dual-energy X-ray absortiometry), were assessed before and after the intervention. γ' fibrinogen concentration was higher in the obese group compared with the normal weight group (P < .05) and was correlated with other risk factors for CVD (adjusted R(2) = 0.9; P < .05), and insulin emerged as the major predictor of γ' fibrinogen. The intervention reduced γ'-fibrinogen concentration (P < .05). CONCLUSION Our data reveal: (1) elevated γ' fibrinogen concentrations in obese insulin-resistant children compared with normal lean controls; (2) a relationship between γ' fibrinogen and other CVD risk factors; and (3) physical activity-induced reduction in γ' fibrinogen in obese children.
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Effects of periodontal therapy on systemic markers of inflammation in patients with metabolic syndrome: a controlled clinical trial.
López, NJ, Quintero, A, Casanova, PA, Ibieta, CI, Baelum, V, López, R
Journal of periodontology. 2012;(3):267-78
Abstract
BACKGROUND The systemic inflammation in both metabolic syndrome (MetS) and periodontitis is a common denominator of the association of these conditions with higher risk of atherosclerosis. The current study investigates whether periodontal therapy may reduce systemic inflammation in patients with MetS and reduce cardiovascular risk. METHODS A parallel-arm, double-blind, randomized clinical trial of 1-year duration in patients with MetS and periodontitis was conducted. Participants were randomized to an experimental treatment group (ETG) (n = 82) that received plaque control and root planing plus amoxicillin and metronidazole or to a control treatment group (CTG) (n = 83) that received plaque control instructions, supragingival scaling, and two placebos. Risk factors for cardiovascular disease were recorded; serum lipoprotein cholesterol, glucose, body mass index (BMI), C-reactive protein (CRP) and fibrinogen concentrations, and clinical periodontal parameters were assessed at baseline and every 3 months until 12 months after therapy. The primary and secondary outcomes were changes in CRP and fibrinogen levels, respectively. RESULTS The baseline patients' characteristics of both groups were similar. No significant changes in lifestyle factors, frequency of hypertension, BMI, serum lipoprotein cholesterol, and glucose levels were observed during the study period. The periodontal parameters significantly improved in both groups 3 months after therapy (P = 0.0001) and remained lower than baseline up to 12 months. The improvement of periodontal status was significantly greater in the ETG (P = 0.0001). A multiple linear regression analysis, controlled for sex, smoking, hypertension, and extent of periodontitis, demonstrated that CRP levels decreased with time and that this reduction was significant at 9 (P = 0.024) and 12 (P = 0.001) months in both groups, without difference between the groups. Fibrinogen levels significantly decreased in the ETG at 6 and 12 months but not in the CTG. CONCLUSION Reduction of periodontal inflammation either with root planing and systemic antibiotics or with plaque control and subgingival scaling significantly reduces CRP levels after 9 months in patients with MetS.
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Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease.
Rodríguez Cristóbal, JJ, Alonso-Villaverde Grote, C, Travé Mercadé, P, Pérez Santos, JM, Peña Sendra, E, Muñoz Lloret, A, Fernández Pérez, C, Bleda Fernández, D, ,
BMC research notes. 2012;:126
Abstract
BACKGROUND We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD) and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids. RESULTS This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA) in l'Hospitalet de Llobregat (Barcelona) and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl), cholesterol < 250 mg/dl, 218 of whom received a more intensive intervention consisting of advice on lifestyle and treatment. The follow-up frequency of the intervention group was every 2 months. The other 218 patients followed their standard care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. CONCLUSION Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol. TRIAL REGISTRATION ClinicalTrials.gov: NCT01089530.