Baseline Fasting Plasma Glucose Research Articles

Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial

ObjectiveHydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system...

Day-to-Day Variations in Fasting Plasma Glucose Do Not Influence Gastric Emptying in Subjects With Type 1 Diabetes.

Acute experimental variations in glycemia decelerate (hyperglycemia) or accelerate (hypoglycemia) gastric emptying. Whether spontaneous variations in fasting plasma glucose (FPG) have a similar influence on gastric emptying is yet unclear. Gastric emptying of a mixed meal was prospectively studied three times in 20 patients with type 1 diabetes and 10 healthy subjects with normal glucose tolerance using a 13C-CO2 octanoate breath test with Wagner-Nelson analysis. The velocity of gastric emptying was related to FPG measured before the test (grouped as low, intermediate, or high). In addition, gastric emptying data from 255 patients with type 1 diabetes studied for clinical indications were compared by tertiles of baseline FPG. Despite marked variations in FPG (by 4.8 [95% CI 3.4; 6.2] mmol/L), gastric emptying did not differ among the three prospective examinations in patients with type 1 diabetes (Δ T1/2 between highest and lowest FPG: 1 [95% CI -35; 37] min; P = 0.90). The coefficient of variation for T1/2 determined three times was 21.0%. Similar results at much lower variations in FPG were found in healthy subjects. In the cross-sectional analysis, gastric emptying did not differ between the tertiles of FPG (Δ T1/2 between highest and lowest FPG: 7 [95% CI -10; 23] min; P = 0.66), when FPG varied by 7.2 (6.7; 7.8) mmol/L. However, higher HbA1c was significantly related to slower gastric emptying. Day-to-day variations in FPG not induced by therapeutic measures do not influence gastric emptying significantly. These findings are in contrast with those obtained after rapidly clamping plasma glucose in the hyper- or hypoglycemic concentrations range and challenge the clinical importance of short-term glucose fluctuations for gastric emptying in patients with type 1 diabetes. Rather, chronic hyperglycemia is associated with slowed gastric emptying.

Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study

IntroductionInvestigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1...

Net benefit index: Assessing the influence of a biomarker for individualized treatment rules.

One central task in precision medicine is to establish individualized treatment rules (ITRs) for patients with heterogeneous responses to different therapies. Motivated from a randomized clinical trial for Type 2 diabetic patients on a comparison of two drugs, that is, pioglitazone and gliclazide, we consider a problem: utilizing promising candidate biomarkers to improve an existing ITR. This calls for a biomarker evaluation procedure that enables to gauge added values of individual biomarkers. We propose an assessment analytic, termed as net benefit index (NBI), that quantifies a contrast between the resulting gain and loss of treatment benefits when a biomarker enters ITR to reallocate patients in treatments. We optimize reallocation schemes via outcome weighted learning (OWL), from which the optimal treatment group labels are generated by weighted support vector machine (SVM). To account for sampling uncertainty in assessing a biomarker, we propose an NBI-based test for a significant improvement over the existing ITR, where the empirical null distribution is constructed via the method of stratified permutation by treatment arms. Applying NBI to the motivating diabetes trial, we found that baseline fasting insulin is an important biomarker that leads to an improvement over an existing ITR based only on patient's baseline fasting plasma glucose (FPG), age, and body mass index (BMI) to reduce FPG over a period of 52 weeks.

Effect of Switching from Low-Dose Simvastatin to High-Dose Atorvastatin on Glucose Homeostasis and Cognitive Function in Type 2 Diabetes.

BackgroundHigh-intensity statin is recommended in high-risk type 2 diabetes (T2D); however, statin dose dependently increases the risk of developing new-onset diabetes, can potentially worsen glycemic control in T2D, and may cause cognitive impairment. This study aimed to investigate the effect of statin intensification on glucose homeostasis and cognitive function in T2D.Materials and MethodsT2D patients who were taking simvastatin ≤20 mg/day were randomized to continue taking the same dosage of simvastatin (low-dose simvastatin group; LS, n=63) for 12 weeks, or to change to atorvastatin 40 mg/day for 6 weeks, and if tolerated, atorvastatin was increased to 80 mg/day for 6 weeks (high-dose atorvastatin group; HS, n=62). Fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), plasma insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and of β-cell function (HOMA-B), cognitive functions using Montreal Cognitive Assessment (MoCA), and Trail Making Test (TMT) were assessed at baseline, 6 weeks, and 12 weeks.ResultsMean age of patients was 58.8±8.9 years, and 72% were female. Mean baseline FPG and HbA1c were 124.0±27.5 mg/dl and 6.9±0.8%, respectively. No differences in baseline characteristics between groups were observed. Change in HbA1c from baseline in the LS and HS groups was −0.1% and +0.1% (p=0.03) at 6 weeks, and −0.1% and +0.1% (p=0.07) at 12 weeks. There were no significant differences in FPG, fasting plasma insulin, HOMA-B, HOMA-IR, MoCA score, or TMT between groups at 6 or 12 weeks.ConclusionSwitching from low-dose simvastatin to high-dose atorvastatin in T2D resulted in a slight increase in HbA1c (0.1%) without causing cognitive decline.

The effects of ertugliflozin on β-cell function: Pooled analysis from four phase 3 randomized controlled studies.

To identify potential predictors and mediators of changes in β-cell function in response to ertugliflozin treatment in people with type 2 diabetes mellitus (T2DM). Data from patients with T2DM randomized to ertugliflozin (5 or 15 mg; observations from both doses were pooled) or placebo in four phase 3 clinical studies (clinicaltrials.gov: NCT01958671, NCT02226003, NCT02036515, NCT02099110) were pooled and analysed. Change from baseline in β-cell function at week 26 was assessed, and its potential predictors and mediators were analysed using linear and multiple regression analyses. Compared with placebo, ertugliflozin improved β-cell function when assessed by mean percent change from baseline in homeostatic model assessment of β-cell function (HOMA-%β; ertugliflozin: 14.7%, 95% confidence interval [CI] 12.3, 17.1; placebo: -0.4%, 95% CI -3.4, 2.5], but not when assessed by change in C-peptide index following a mixed meal tolerance test. Change in HOMA-%β correlated with change from baseline in glycated haemoglobin (HbA1c) and treatment with ertugliflozin, and weakly with change from baseline in body weight. In the ertugliflozin group, change in HOMA-%β correlated with baseline fasting plasma glucose (FPG; r = 0.235, P < 0.001), baseline HbA1c (r = 0.138, P < 0.001), baseline homeostatic model assessment of insulin resistance (HOMA-IR; r = 0.162, P < 0.01), and baseline HOMA-%β (r = -0.321, P < 0.001) in linear regression analyses. Multiple regression analyses yielded similar results. In people with T2DM, ertugliflozin treatment improved fasting β-cell function, but no effect on postprandial β-cell function was observed in this analysis. Improvement in HOMA-%β was predicted by high baseline FPG, HbA1c, HOMA-IR, and low baseline HOMA-%β, and mediated by ertugliflozin treatment, and improved HbA1c and body weight.

Metformin Should Not Be Used to Treat Prediabetes.

Based on the results of the Diabetes Prevention Program Outcomes Study (DPPOS), in which metformin significantly decreased the development of diabetes in individuals with baseline fasting plasma glucose (FPG) concentrations of 110-125 vs. 100-109 mg/dL (6.1-6.9 vs. 5.6-6.0 mmol/L) and A1C levels 6.0-6.4% (42-46 mmol/mol) vs. <6.0% and in women with a history of gestational diabetes mellitus, it has been suggested that metformin should be used to treat people with prediabetes. Since the association between prediabetes and cardiovascular disease is due to the associated nonglycemic risk factors in people with prediabetes, not to the slightly increased glycemia, the only reason to treat with metformin is to delay or prevent the development of diabetes. There are three reasons not to do so. First, approximately two-thirds of people with prediabetes do not develop diabetes, even after many years. Second, approximately one-third of people with prediabetes return to normal glucose regulation. Third, people who meet the glycemic criteria for prediabetes are not at risk for the microvascular complications of diabetes and thus metformin treatment will not affect this important outcome. Why put people who are not at risk for the microvascular complications of diabetes on a drug (possibly for the rest of their lives) that has no immediate advantage except to lower subdiabetes glycemia to even lower levels? Rather, individuals at the highest risk for developing diabetes-i.e., those with FPG concentrations of 110-125 mg/dL (6.1-6.9 mmol/L) or A1C levels of 6.0-6.4% (42-46 mmol/mol) or women with a history of gestational diabetes mellitus-should be followed closely and metformin immediately introduced only when they are diagnosed with diabetes.

1258-P: Lack of Monitoring for Glucose Intolerance in Overweight and Obese Youth on Second-Generation Antipsychotics Despite Increased Risk

Second-generation antipsychotics (SGAs) increase risk for glucose intolerance in adults; less is known about risk in youth. MOBILITY is a large, multi-center, pragmatic study designed to assess the effect of metformin added to a lifestyle intervention compared to lifestyle alone on weight gain and metabolic parameters in overweight and obese pediatric (ages 8-19) patients with bipolar-spectrum disorders (BSD) receiving SGAs. Frank diabetes was an exclusion criterion. It was recommended to obtain baseline, +6 month, and +12 month fasting metabolic labs in this trial conducted in real-world psychiatry clinics. We estimated prevalence of glucose intolerance prior to intervention. We hypothesized that youth with elevated fasting plasma glucose (FPG) and hemoglobin A1C (HbA1C) would be more likely to have repeat metabolic assessment. Altogether, 684 youth (mean age=14.3 years, 53% male, 64% with baseline BMI ≥95th%ile) were included in these analyses. Baseline FPG was obtained in 73% (501/684); 12.1% of these had impaired fasting glucose (IFG). Baseline HbA1C was obtained in 53% (360/684); 11.1% had HbA1C ≥5.7%. Six patients (1.6%) had both measures elevated. Only 41% of patients with IFG and 40% of those with HbA1C ≥5.7% had repeat glucose measures within 1 year; neither were more likely to have repeat laboratory testing than patients with normal baseline laboratory results (OR=0.88, p=0.773; OR=0.85; p=1.00, respectively). Of six patients with both IFG and HbA1C elevated at baseline, only three had repeat laboratory testing; one of these developed diabetes on follow-up. Overweight and obese youth with BSD on SGA therapy have clinically relevant rates of glucose intolerance. However, assessment and, especially, reassessment of abnormal glucose status in this population is poor. Further studies are needed to identify and address barriers for evaluation for glucose intolerance in this at-risk population. Disclosure N.A. Crimmins: None. M.P. DelBello: None. C. Correll: Consultant; Self; Alkermes plc., Allergan plc., Janssen Pharmaceuticals, Inc., Lundbeck, Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., Sumitomo Dainippon Pharma Co., Ltd., Sunovion Pharmaceuticals Inc., Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd. C. Klein: None. T. Blom: None. J. Welge: None. Funding Patient-Centered Outcomes Research Institute (to M.P.D.)

1471-P: Efficacy of Lifestyle Intervention in Preventing Diabetes in People with IGT with and without Impaired Fasting Glucose: A Secondary Analysis of Da Qing Diabetes Prevention Outcomes Study (DQDPOS)

Although major diabetes prevention trials show lifestyle intervention delays the onset of type 2 diabetes in persons with impaired glucose tolerance (IGT), impaired fasting glucose (IFG) is typically used in the real world as a more convenient way to identify eligible persons. Such practice includes many without IGT but excludes many with IGT who could benefit from intervention programs. DQDPOS is a long-term follow-up of the Da Qing Diabetes Prevention study, a randomized clinical trial to assess the efficacy of lifestyle intervention to prevent type 2 diabetes in persons with IGT in Da Qing China. We compared the effect of the intervention in those with baseline fasting plasma glucose (FPG) levels of &amp;lt;100 (“normal”, n=287,49.8%) vs. 100-139mg/dl (IFG, n=289,50.2%). Lifestyle intervention reduced diabetes incidence substantially and to a similar extent in both groups at the end of the 6-year intervention and throughout the 30 years of follow-up (hazard ratios 0.50-0.67) (Table). Our results indicate that although using only IFG to identify candidates for lifestyle intervention programs might achieve similar efficacy, its use alone will exclude large numbers of people with IGT but without IFG, who otherwise would benefit from lifestyle interventions. Disclosure Q. Gong: None. P. Zhang: None. J. Wang: None. Y. Chen: None. Y. An: None. X. Feng: None. Y.J. Cheng: None. J. Ma: None. P.H. Bennett: Advisory Panel; Self; World Health Organization. Stock/Shareholder; Self; Eli Lilly and Company, Pfizer Inc., Unilever, UnitedHealth Group. Other Relationship; Self; American Diabetes Association, European Association for the Study of Diabetes, European Diabetic Nephropathy Study Group, International Diabetes Federation, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. G. Li: None.

1117-P: Cardiovascular and Glycemic Benefits of Bexagliflozin as an Adjunct to Metformin for the Treatment of Type 2 Diabetes in Adults: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Trial

Bexagliflozin is a potent and selective sodium glucose co-transporter 2 inhibitor. To evaluate the safety and effectiveness of bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes mellitus, participants (317) were randomized to receive bexagliflozin or placebo in addition to ongoing treatment with metformin. The primary endpoint was the placebo-adjusted change in HbA1c from baseline to week 24. Changes in systolic blood pressure (SBP), fasting plasma glucose (FPG) and body mass were secondary endpoints. The study also enrolled an open label arm of participants with elevated HbA1c. Including post-rescue observations, the mean change in HbA1c was 1.09% (95% CI 1.24%, 0.94%) in the bexagliflozin arm and 0.56% ( 0.71%, 0.41%) in the placebo arm, for a difference of -0.53% ( 0.74%, 0.32%; p &amp;lt; 0.0001). By the last-observation-carried-forward method, the intergroup difference was -0.70% ( 0.92, 0.48; p &amp;lt; 0.0001). The open label cohort experienced a mean change in HbA1c of 2.82% ( 3.23%, -2.41%). The placebo-adjusted changes from baseline SBP, FPG and body mass and SBP were 7.07 mm Hg ( 9.83, -4.32; p &amp;lt; 0.0001), -1.35 mmol L-1 (-1.83, -0.86; p &amp;lt; 0.0001) and 2.51 kg (-3.45, -1.57; p &amp;lt; 0.0001). Adverse events were experienced by 42.4% and 47.2% of subjects in the bexagliflozin and placebo arms, respectively, and fewer subjects in the bexagliflozin arm experienced serious adverse events. Bexagliflozin produced clinically meaningful and statistically significant improvement in measures of cardiovascular health and glycemic control in a population of diabetic adults inadequately controlled by metformin alone. ClinicalTrials.gov Identifier: NCT03259789. Disclosure Y.C. Halvorsen: Research Support; Self; Theracos, Inc. J.P. Lock: None. M.W. Freeman: Research Support; Self; Theracos, Inc.

1476-P: Progression to Type 2 Diabetes from Normal or Impaired Fasting Glucose

The interaction of anthropometric variables with fasting blood glucose on progression from normal fasting glucose to overt diabetes (DM), is uncertain. In the Rochester Epidemiology Project (MN, USA), we identified 44,992 individuals with ≥ 2 fasting plasma glucose (FPG) tests from 2005-17, after excluding people who met criteria for DM (FPG &amp;gt; 125mg/dL) on/before their first FPG. The cohort was 58% female, had an age range of 18-65 yrs (44 ± 10, Mean ± SD) and BMI of 29 ± 7 kg/m2. Subjects who did not develop DM were censored at their last FPG value on/before Dec 31, 2017. Those who developed DM were assigned an event date as the first diagnostic value. Over a median follow-up of 7 yrs, 3888 (8.6%) developed DM. The Kaplan-Meier 10-year cumulative risk of incident DM was 12.8% (CI 12.4%-13.3%). As expected, multivariable Cox modeling identified elevated initial FPG [100-109mg/dL (HR 2.0; 1.9-2.2); 110-125mg/dL (HR 5.8; 5.4-6.3)] as conferring increased risk. Other independent risks were male sex (HR 1.30; 95% CI 1.22-1.38) and abnormal BMI [&amp;lt;18 kg/m2 (2.67; 1.96-3.63), 25-29.9 kg/m2 (1.37; 1.23-1.52), 30-34.9 kg/m2 (2.15; 1.92-2.39), ≥ 35 kg/m2 (3.59; 3.23-3.99)]. A very strong, nonlinear, age effect was also noted, with a fitted hazard ratio for age 60 versus 20 of 2.65. In this large cohort, male sex, age and abnormal category of BMI (including underweight) are associated with increased risk of progression to DM and additive to baseline FPG. Disclosure A.M. Egan: None. C. Wood-Wentz: None. K.R. Bailey: None. A. Vella: Advisory Panel; Self; vTv Therapeutics, Zealand Pharma A/S. Research Support; Self; Novo Nordisk A/S, Xeris Pharmaceuticals, Inc.

Effect of Curcumin on Serum Urate in Asymptomatic Hyperuricemia: A Randomized Placebo-Controlled Trial

Background/objective Hyperuricemia leads to gout and renal complications and may increase cardiovascular risk. Curcumin inhibits xanthine oxidase and increases uricosuric activity and, as a result, decreases serum urate (SU). This randomized controlled trial aimed to determine the effects of curcumin versus placebo on SU in subjects with asymptomatic hyperuricemia (SU level ≥ 6 mg/dL in women or ≥ 7 mg/dL in men). Methods Thirty-nine subjects with persistent hyperuricemia were randomized to receive curcumin (500-mg capsules twice daily, 20 subjects) or placebo (19 subjects). Primary outcome was the difference between SU before and 8 weeks after randomization. Secondary outcomes were differences between urine uric acid (UUA) clearance, fasting plasma glucose (FPG), and lipid profiles before and 8 weeks after randomization and adverse events. Results Out of 39 subjects, there were no differences at baseline SU, UUA clearance, FPG, lipid profiles, and demographics between curcumin and placebo groups. After 8 weeks, SU was significantly decreased in both groups (6.9% in curcumin group, p = 0.002, and 5.0% in placebo group, p = 0.009). However, there was no difference in SU reduction between the two groups (p = 0.532). There were no differences in UUA, FPG, lipid profiles, or adverse events in either group at 8 weeks after randomization. The most common adverse event was diarrhea with no treatment required. Conclusion Curcumin was not superior to placebo in reducing serum urate and in increasing UUA clearance.

OR30-07 Mixed Meal Tolerance Test (MMTT) Results from Revita-2, the First Randomized, Sham-Controlled, Double-Blind, Prospective, Multicenter Study of Duodenal Mucosal Resurfacing (DMR) Safety and Efficacy in Patients with Sub-Optimally Controlled Type 2 Diabetes (T2D)

BACKGROUND: The duodenum is a key metabolic signaling center and regulator of metabolic homeostasis. Duodenal mucosal hyperplasia is therefore a potential therapeutic target for metabolic diseases related to insulin-resistance. Previous reports demonstrated that DMR, a minimally invasive, endoscopic mucosal ablative procedure, safely improves hepatic and glycemic parameters. Primary endpoints from REVITA-2, the first randomized, sham-controlled, double-blind, prospective, multicenter study of DMR safety and efficacy in patients with T2D, were met and previously reported. Here we further explore mechanisms underlying the beneficial effects of DMR on hepatic and glucose metabolism by analyzing mixed meal tolerance test (MMTT) data from the REVITA-2 study. Methods: Eligible patients (HbA1c 7.5–10%, BMI ≥ 24 to ≤ 40 kg/m2, on stable treatment with ≥1 oral anti-diabetic medication) received DMR or sham procedure (1:1). Exploratory endpoints included median change in fasting plasma glucose (FPG), MMTT glucose area under the curve (AUC) over 2 hours, and change in MMTT C-peptide and glucagon over 2 hours, from baseline to 12 weeks post-DMR. One-sided P value based on ANCOVA model on ranks without imputation assessed treatment difference at the 0.05 significance level. The modified intent to treat primary analysis population included randomized patients in whom study procedure was attempted. Results: A total of 70 patients (DMR, N = 35; sham, N = 35) were included in the analysis, of which 57% and 54% (DMR, n = 20; sham, n = 19) had baseline FPG ≥ 180 mg/dL. Median MMTT AUC for glucose was significantly reduced post-DMR (-36.38 mg/dL) compared with sham (-4.94 mg/dL; P = 0.009), driven by a significant decrease in FPG (DMR, -41.0 mg/dL; sham, -15.0 mg/dL; P = 0.003) rather than median MMTT postprandial glucose excursion (DMR, -4.63 mg/dL; sham, 5.34 mg/dL; P = 0.209). AUC glucose reductions were more pronounced in patients with baseline FPG ≥ 180 (DMR, -63.03 mg/dL; sham, -20.31 mg/dL; P = 0.007) compared with baseline FPG < 180 (DMR, -26.81 mg/dL; sham, 13.81 mg/dL; P = 0.271). In patients with baseline FPG ≥ 180, postprandial C-peptide excursion was significantly increased (DMR, 0.41 ng/mL; sham, 0.02 ng/mL; P = 0.012) and postprandial glucagon excursion was significantly decreased (DMR, -8.03 pg/mL; sham, 2.13 pg/mL; P = 0.027). Conclusion: DMR markedly improves glucose responses to a mixed meal challenge, primarily driven by a decrease in FPG, suggesting a primary effect on insulin resistance. Increases in C-peptide and reductions in glucagon levels suggest improvement in beta cell function in addition to improvements in hepatic insulin sensitivity, and ratifies the position of the duodenum as both a culprit endocrine organ and therapeutic target for patients with T2D.

A Double-Blind Randomized Placebo-Controlled Study Assessing the Safety, Tolerability and Efficacy of a Herbal Medicine Containing Pycnogenol Combined with Papain and Aloe vera in the Prevention and Management of Pre-Diabetes.

Background: Herbal medicines present attractive options to patients with chronic diseases. Undertaking clinical studies with patients presenting with symptomless pre-T2D can lead to significant limitations. Methods: A 12-week randomized double-blind placebo-controlled clinical study was conducted that investigated the safety and efficacy of an herbal formulation administered orally for the treatment of pre-type 2 diabetes (pre-T2D). Results: A numerically greater proportion of subjects in the interventional arm had impaired fasting glucose (IFG) at week 12 compared to the control arm (71.0% vs. 69.0%, p = 0.75). Fewer participants had impaired glucose tolerance (IGT) at 12 weeks in the intervention arm compared to the control arm (unadjusted 58.3% vs. 66.7%, p = 0.65; adjusting for baseline IGT, p = 0.266). In a subgroup analysis, subjects with a baseline fasting plasma glucose (FPG) level in the range of 6.1–6.9 mmol/L demonstrated a non-significant lower proportion of IFG at week 12 in the intervention arm compared to the control arm (60.0% vs. 41.7% p = 0.343). Total blood cholesterol and triglyceride levels remained unchanged from baseline to week 12 in both treatment groups. Conclusions: This study suggests that a polyherbal medicine was not effective for reducing the metabolic markers associated with pre-T2D over a 12-week period. Therefore, larger studies with well-defined endpoints and of longer duration are warranted.

Blood Glucose Levels in Elderly Subjects with Type 2 Diabetes During COVID-19 Outbreak: A Retrospective Study in a Single Center

Aims: Ideal glycemic control is of great importance for diabetic patients during public health emergencies of infectious diseases as long-term hyperglycemic are not only associated with chronic complications but also vital drivers of common and life-threatening infections. The present study was designed to investigate the changes of blood glucose levels in elderly subjects with type 2 diabetes(T2D) during COVID-19 outbreak. Methods:This retrospective study focused on the T2D outpatients at Fujian Provincial Hospital aged 65 years old and above who received baseline test for fasting plasma glucose and/or glycated hemoglobin (HbA1c) between January 1, 2019 and March 8, 2019 and were followed up on fasting plasma glucose and/or HbA1c in the same period in 2020. The baseline and follow-up data were analyzed with the paired-samples T-test. Results: A total of 135 elderly subjects with T2D with baseline and follow-up fasting plasma glucose and 50 elderly subjects with T2D with baseline and follow-up HbA1c were analyzed, respectively. The baseline and follow-up fasting plasma glucose were 7.08±1.80 and 7.48±2.14 mmol/L, respectively (P=0.008). The baseline and follow-up HbA1c were 7.2±1.7% and 7.4±1.8%, respectively (P=0.158). Conclusions: Elderly subjects with T2D had higher fasting plasma glucose levels during COVID-19 outbreak. We should pay more attension to the management of diabetics during public health emergencies. Funding Statement: None. Declaration of Interests: No conflict of interest has been declared by the authors. Ethics Approval Statement: This retrospective study was approved by the Ethics Committee of Fujian Provincial Hospital. Due to the retrospective nature of the study, informed consent was waived. Subjects information was anonymized at the collection and analysis stage.

High fat diets for weight loss among subjects with elevated fasting glucose levels: The PREDIMED study

AimWe studied fasting plasma glucose (FPG) as a determinant of weight change on high-fat diets in the PREDIMED trial. MethodsA total of 3,622 participants were randomized to receive one of two Mediterranean diets (n = 2,616) or a control diet (n = 1,006) for 5 years and had complete data for baseline FPG and body-weight development. Weight change by pre-treatment FPG categories (<100 mg/dL; 100–114.9 mg/dL; 115–125.9 mg/dL; ≥126 mg/dL) were examined. ResultsThe two Mediterranean diets contained 41.5 E% fat, 16.5 E% protein, and 40 E% carbohydrate whereas the control diet contained 37.8 E% fat, 16.8 E% protein and 43.2 E% carbohydrate. In the Mediterranean diet groups, participants with FPG≥115 lost 1.04 kg (95% CI 0.68; 1.41, n = 1115) whereas participants with FPG<115 mg/dL lost 0.30 kg (95% CI -0.01; 0.60, n = 1501) resulting in a between-group difference of 0.75 kg (95% CI 0.20; 1.30, P = 0.007). Similar, although none-significant, between-group difference was observed in the control group [0.70 kg (95% CI -0.25; 1.65, P = 0.15)]. ConclusionsParticipants with elevated pre-treatment FPG lost more weight than participants with lower FPG on these three moderate to high fat diets. Although the effect size is small, results are important as these individuals represent those in most need of weight loss.

Relative frequency of urinary tract infections in patients affected by diabetes mellitus type 2 treated with metformin and SGLT2 inhibitor. Network meta-analysis

Introduction and aim: The of this research was to conduct a network meta-analysis based on a systematic literature search to compare the relative frequency of urinary tract infections using sodium-glucose cotransporter-2 (SGLT2) inhibitors combined with metformin in the therapy of type 2 diabetes. Method: MEDLINE and EMBASE databases were searched to identify publications of randomized, controlled trials investigating SGLT2 inhibitors combined with metformin in the therapy of type 2 diabetes and providing information on the frequency of urinary tract infections. Results: 10165 unique citations were screened to identify 10 publications to be included in the network meta-analysis. The network meta-analysis showed reduced risk of urinary tract infections for low-dose ertugliflozin compared to other SGLT2 inhibitors (ertugliflozin 5 mg vs. empagliflozin 10 mg: RR: 0.606, 95% CrI: 0.264-1.415; ertugliflozin 5 mg vs. dapagliflozin 10 mg: RR = 0.853, 95% CrI: 0.301-2.285). For high-dose comparisons, empagliflozin 25 mg showed reduced risk of urinary tract infections compared to both ertugliflozin 15 mg (RR = 0.745, 95% CrI 0.330-1.610) and dapagliflozin 10 mg (RR = 0.680, 95% CrI: 0.337-1.289). The difference between active substances and their doses was not statistically significant for the relative frequency of urinary tract infections. The meta-regression revealed a statistically significant association between baseline fasting plasma glucose level and relative frequency of urinary tract infections (β = 0.785, 95% CrI: 0.062-1.587). Conclusion: There was no statistically significant difference between SGLT2 inhibitors investigated in this study in terms of the relative frequency of urinary tract infections. This research demonstrates the applicability of network meta-analyses when assessing the relative effectiveness and safety of interventions. Orv Hetil. 2020; 161(13): 491-501.

Independent and Opposite Associations Between Branched-Chain Amino Acids and Lysophosphatidylcholines With Incident Diabetes in Thais.

Branched-chain amino acids (BCAAs) and lysophosphatidylcholines (LPCs) have been reported to be associated with diabetes. The purpose of the present study was to investigate the relative contributions of BCAAs and LPCs to the progression of prediabetes to diabetes using a targeted metabolomic approach. This study was part of a health survey of employees of the Electricity Generating Authority of Thailand (n = 79; nine females and 70 males). A targeted metabolomics analysis was performed using an AbsoluteIDQ® p180 kit, flow injection analysis, and liquid chromatography-tandem mass spectrometry. The highest variable importance in projection (VIP) scores for the progression to diabetes of the amino acids and phospholipids were associated with isoleucine and LPC acyl C28:1, respectively. Using logistic regression analysis, we found that high baseline isoleucine concentration was associated with a higher incidence of diabetes, while high LPC acyl 28:1 was associated with a lower incidence. Isoleucine and LPC acyl 28:1 were independently associated with incident diabetes in a model that also included conventional risk factors for diabetes (baseline fasting plasma glucose (FPG), age, sex, and body mass index (BMI)). In addition, isoleucine and LPC acyl 28:1 were independently associated with serum HbA1c 5 years later in a robust regression model that also included baseline FPG, age, sex, and BMI. Isoleucine, LPC acyl 28:1, age, and FPG were significantly associated with HbA1c at this time. In conclusion, these results provide evidence that isoleucine and LPC acyl C28:1 have respective positive and negative independent associations with incident diabetes.

Hepatitis C Virus Clearance with Glucose Improvement and Factors Affecting the Glucose Control in Chronic Hepatitis C Patients

The study aimed to investigate whether the glucose level improves and what factors affect the improvement in glucose control after the eradication of hepatitis C virus (HCV). A total of 1090 patients with HCV infections were enrolled, among which 278 (25.5%) patients were diagnosed with prediabetes, and 89 (8.16%) patients were diagnosed with diabetes. In the cohort, 990 patients belonged to sustained virological response (SVR) group and 100 belonged to non-SVR group. Decreases in the fasting plasma glucose (FPG) level were found in the SVR group but not in the non-SVR group (p < 0.001; p = 0.267). In the SVR group, subjects with baseline FPG ≥ 5.6 mmol/L were further stratified into glycometabolism-improved (N = 182) and unimproved (N = 150) groups according to their FPG after viral eradication. Multivariate analysis showed that older age, higher baseline HCV RNA, glucose, total bilirubin and alanine aminotransferase levels were independent risk factors for insufficient glucose improvement. In conclusion, patients with HCV infection had a higher prevalence of abnormal glycometabolism. It could be improved after viral eradication, indicating that HCV may influence glycometabolism. Moreover, Age, baseline HCV RNA, glucose, total bilirubin and alanine aminotransferase levels were impact factor for glycometabolism improvement after viral eradication.

Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data

BackgroundTo examine the impact on glycemic control of achieving postprandial glucose (PPG) target with lixisenatide, a once-daily glucagon-like peptide-1 receptor agonist approved in the US, in patients with uncontrolled type 2 diabetes (T2D) on basal insulin, an agent that primarily targets fasting plasma glucose.MethodsA post hoc pooled analysis was conducted using clinical trial data extracted from the intent-to-treat subpopulation of patients with T2D who participated in the 24-week, phase 3, randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter GetGoal-L (NCT00715624), GetGoal-Duo 1 (NCT00975286) and GetGoal-L Asia trials (NCT00866658).ResultsData from 587 lixisenatide-treated patients and 484 placebo-treated patients were included. Patients on lixisenatide were more likely to achieve a PPG target of < 10 mmol/L (< 180 mg/dL) than placebo-treated patients (P < 0.001), regardless of baseline fasting plasma glucose (FPG) levels. More importantly, those who reached the PPG target experienced a significantly greater reduction in mean HbA1c, were more likely to achieve HbA1c target of < 53 mmol/mol (< 7.0%), and experienced weight loss. Those outcomes were achieved with no significant differences in the risk of symptomatic hypoglycemia compared with placebo.ConclusionCompared with placebo, addition of lixisenatide to basal insulin improved HbA1c and reduced PPG, without increasing hypoglycemia risk. These findings highlight the importance of PPG control in the management of T2D, and provide evidence that adding an agent to basal insulin therapy that also impacts PPG has therapeutic value for patients who are not meeting glycemic targets.Trial registrationNCT00715624. Registered 15 July 2008, NCT00975286. Registered 11 September 2009, NCT00866658. Registered 20 March 2009.