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Pharmacokinetics and safety profile of desmopressin oral tablet formulations in healthy Chinese subjects under fasting and fed conditions.
Li, X, Zhang, H, Zhu, X, Li, C, Chen, H, Liu, J, Chen, G, Wu, M, Liu, C, Shen, Z, et al
International journal of clinical pharmacology and therapeutics. 2018;(9):434-442
Abstract
OBJECTIVE Desmopressin acetate (DDAVP®) is a synthetic analogue of the pituitary hormone vasopressin. Until now, few studies of desmopressin have focused on the pharmacokinetics (PK) or food effects in Asian populations. This study aimed to assess the effect of food intake on the PK of desmopressin and bioequivalence of two tablet formulations in Chinese subjects. MATERIALS AND METHODS A single-center, single-dose, randomized, open-label, two-period crossover study was conducted in 104 healthy Chinese volunteers under fasted or fed conditions (52 volunteers for each condition). Blood samples were collected up to 14 hours after administration of oral desmopressin tablets (0.6 mg; 0.2 mg × 3) in each period. Plasma desmopressin concentrations were analyzed by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). PK and bioavailability parameters were calculated. Adverse events (AEs) were also recorded. RESULTS No significant differences in mean (standard deviation, SD) PK parameters were observed between formulation 1 (F1) and formulation 2 (DDAVP®; F2) under both fasted and fed conditions. All AEs observed were mild and resolved quickly without treatment. The maximum concentration (Cmax) and area under the curve (AUC) were significantly decreased (p < 0.01) when the drug was taken with food, compared with fasted subjects. CONCLUSION These findings suggest that both tablet formulations were well tolerated. Food can significantly decrease the exposure of desmopressin.
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Trans-ethnic Meta-analysis and Functional Annotation Illuminates the Genetic Architecture of Fasting Glucose and Insulin.
Liu, CT, Raghavan, S, Maruthur, N, Kabagambe, EK, Hong, J, Ng, MC, Hivert, MF, Lu, Y, An, P, Bentley, AR, et al
American journal of human genetics. 2016;(1):56-75
Abstract
Knowledge of the genetic basis of the type 2 diabetes (T2D)-related quantitative traits fasting glucose (FG) and insulin (FI) in African ancestry (AA) individuals has been limited. In non-diabetic subjects of AA (n = 20,209) and European ancestry (EA; n = 57,292), we performed trans-ethnic (AA+EA) fine-mapping of 54 established EA FG or FI loci with detailed functional annotation, assessed their relevance in AA individuals, and sought previously undescribed loci through trans-ethnic (AA+EA) meta-analysis. We narrowed credible sets of variants driving association signals for 22/54 EA-associated loci; 18/22 credible sets overlapped with active islet-specific enhancers or transcription factor (TF) binding sites, and 21/22 contained at least one TF motif. Of the 54 EA-associated loci, 23 were shared between EA and AA. Replication with an additional 10,096 AA individuals identified two previously undescribed FI loci, chrX FAM133A (rs213676) and chr5 PELO (rs6450057). Trans-ethnic analyses with regulatory annotation illuminate the genetic architecture of glycemic traits and suggest gene regulation as a target to advance precision medicine for T2D. Our approach to utilize state-of-the-art functional annotation and implement trans-ethnic association analysis for discovery and fine-mapping offers a framework for further follow-up and characterization of GWAS signals of complex trait loci.
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Fasting blood glucose at admission and survival in patients with dilated cardiomyopathy: a single-center cohort study.
Li, X, Jiang, R, Kong, H, Shu, Y, Li, Q, Hua, W
Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association. 2014;(8):457-62
Abstract
BACKGROUND Recent data have suggested that impaired fasting glucose (IFG) is an independent risk factor for mortality in patients with heart failure. However, the prognostic indicator of elevated fasting blood glucose (FBG) such as IFG in dilated cardiomyopathy (DCM) was not well understood. The purpose of this study was to examine the association between IFG at admission and survival in hospitalized patients with DCM. METHODS A retrospective cohort study was undertaken in 1 089 hospitalized patients with DCM in Fuwai Hospital from November 2003 to September 2 011 (female 26.5%, 51.4±14.6 years old). Standard demographics, echocardiography and routine blood samples were obtained shortly after admission. The outcomes were assessed using all-cause mortality at a mean follow-up of 3.5±2.3 years and were analyzed using Kaplan-Meier survival curve (log-rank test) and Cox regression. RESULTS The cohort consisted of 1 089 patients with DCM, 835 patients with normal fasting glucose (NFG, FBG<6.1 mmol/L, 76.7%), 113 patients with IFG (FBG 6.1-6.9 mmol/L, 10.4%), and 141 patients with FBG≥7.0 mmol/L (12.9%). Among the 1 089 patients studied, 252 (23.1%) died over a mean follow-up period of 3.5±2.3 years. All-cause mortality rates were highest in patients with FBG≥7.0 mmol/L (31.2%), intermediate in those with IFG (24.8%), and lowest in those with NFG (21.6%); a significant difference in all-cause mortality rate was found among the 3 groups (log-rank χ(2)=6.715, P=0.035). After adjustment for baseline variables, New York Heart Association (NYHA) functional class, QRS duration, left atrium diameter, systolic blood pressure, FBG≥7.0 mmol/L, not IFG, and circulating creatinine levels were the variables that remained as predictors of all-cause mortality. CONCLUSION In the present study, all-cause mortality was higher in patients with FBG≥7.0 mmol/L compared to the patients with NFG, and FBG≥ 7.0 mmol/L, not IFG, was one of predictors of all-cause mortality in DCM patients.
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[Effects of barley flake on metabolism of glucose and lipids in the patients with impaired fasting glucose].
Bi, M, Niu, Y, Li, X, Li, Y, Sun, C
Wei sheng yan jiu = Journal of hygiene research. 2013;(5):719-23, 782
Abstract
OBJECTIVE To investigate the effects of barley flake (BF) on the glucose-lipid metabolism in patients with impaired fasting glucose (IFG). METHODS 100 patients with IFG were divided into the oat meal (OM) control group and barley flake experimental group for three months intervention according to randomized controlled trail (RCT). Biochemical indicators, glucose-lipid metabolism related enzymes, the area under curve (AUC) of blood glucose and insulin after oral glucose tolerance test (OGTT) were assessed before and after intervention. In addition, the homeostasis model assessment of insulin resistance (HOMA-IR) was calculated by FBG (mmol/L) x INS (microU/L)/ 22.5. RESULTS At the end of the three month active intervention, the mean fasting blood glucose (FBG) and insulin (INS) in the patients with BF treatment decreased by 9.26% (P < 0.001) and 13.37% (P = 0.001) separately compared with that in patients with OM treatment; meanwhile, total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) in patients with BF treatment also decreased by 7.20% (P < 0.001) and 9.42% (P = 0. 002), respectively. Glycosylated hemoglobin (HbA1c), HOMA-IR, total glyceride (TG), Apo-B, the AUC of blood glucose and insulin after OGTT were also significantly decreased separately (P < 0.01 or < 0.05 ). However, statistically significant differences failed to be found in HDL-C, Apo-A, ALP and SOD between these two groups. CONCLUSION BF had favorable effect on improvement of glucose-lipid metabolism in the patients with impaired fasting glucose.
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Effect of diacylglycerol supplementation on fasting serum triacylglycerol concentration: a meta-analysis.
Wang, W, Xu, T, Li, X, Zhu, Q, Cheng, A, Du, F, Li, D
Lipids. 2010;(12):1139-46
Abstract
Diacylglycerol (DAG) supplementation has been shown to be associated with the reduction of fasting serum triacylglycerol (TAG) concentration, although the extent of the association is uncertain. We quantitatively examined the effect of dietary DAG on fasting serum TAG concentration by conducting a meta-analysis of randomized controlled trials. Potential papers were searched from electronic databases of Medline, Embase and Cochrane Library. Information was extracted and the net change of fasting serum TAG concentration was used as the primary outcome to examine the effect of DAG in Review Manager 4.2. Six papers with seven independent studies (298 subjects) were included into the statistic pooling. Meta-analysis with random effect model showed that DAG did not reduce the fasting serum TAG concentration (WMD: -0.07 mmol/L; 95% CI: -0.21 to 0.08 mmol/L; P = 0.37). Sensitivity analysis indicated the robustness of overall results. Fail-safe number analysis indicated that 18 studies with positive effect were necessary to reverse the reported non-significant efficacy of DAG. Weight estimation analysis indicated that the effect of DAG was influenced to some extent by the initial fasting serum TAG concentration. In conclusion, DAG supplementation did not reduce the fasting serum TAG concentration significantly compared with TAG, but some effects were suggested in diabetic patients with hypertriglyceridemia.
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Chinese herbal medicines for people with impaired glucose tolerance or impaired fasting blood glucose.
Grant, SJ, Bensoussan, A, Chang, D, Kiat, H, Klupp, NL, Liu, JP, Li, X
The Cochrane database of systematic reviews. 2009;(4):CD006690
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Abstract
BACKGROUND Around 308 million people worldwide are estimated to have impaired glucose tolerance (IGT); 25% to 75% of these will develop diabetes within a decade of initial diagnosis. At diagnosis, half will have tissue-related damage and all have an increased risk for coronary heart disease. OBJECTIVES The objective of this review was to assess the effects and safety of Chinese herbal medicines for the treatment of people with impaired glucose tolerance or impaired fasting glucose (IFG). SEARCH STRATEGY We searched the following databases: The Cochrane Library, PubMed, EMBASE, AMED, a range of Chinese language databases, SIGLE and databases of ongoing trials. SELECTION CRITERIA Randomised clinical trials comparing Chinese herbal medicines with placebo, no treatment, pharmacological or non-pharmacological interventions in people with IGT or IFG were considered. DATA COLLECTION AND ANALYSIS Two authors independently extracted data. Trials were assessed for risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, outcome assessors and intervention providers, incomplete outcome data, selective outcome reporting and other sources of bias. MAIN RESULTS This review examined 16 trials lasting four weeks to two years involving 1391 participants receiving 15 different Chinese herbal medicines in eight different comparisons. No trial reported on mortality, morbidity or costs. No serious adverse events like severe hypoglycaemia were observed. Meta-analysis of eight trials showed that those receiving Chinese herbal medicines combined with lifestyle modification were more than twice as likely to have their fasting plasma glucose levels return to normal levels (i.e. fasting plasma glucose <7.8 mmol/L and 2hr blood glucose <11.1 mmol/L) compared to lifestyle modification alone (RR 2.07; 95% confidence intervall (CI) 1.52 to 2.82). Those receiving Chinese herbs were less likely to progress to diabetes over the duration of the trial (RR 0.33; 95% CI 0.19 to 0.58). However, all trials had a considerable risk of bias and none of the specific herbal medicines comparison data was available from more than one study. Moreover, results could have been confounded by rates of natural reversion to normal glucose levels. AUTHORS' CONCLUSIONS The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co-interventions, unclear methods of randomisation, poor reporting and other risks of bias.