Baseline Fasting Plasma Glucose Levels Research Articles

J-shape relationship between normal fasting plasma glucose and risk of type 2 diabetes in the general population: results from two cohort studies

BackgroundPrevious studies have reported that high fasting plasma glucose (FPG), even that within the normal range, is associated with the risk of type 2 diabetes (T2D). Nevertheless, these findings are limited to specific populations. Thus, studies in the general population are imperative.MethodsThis study included two cohorts comprising 204 640 individuals who underwent physical examinations at the Rich Healthcare Group present at 32 locations in 11 cities of China from 2010 to 2016 and 15 464 individuals who underwent physical tests at the Murakami Memorial Hospital in Japan. Cox regression, restricted cubic spline (RCS), Kaplan–Meier (KM) curves, and subgroup analysis were used to determine the relationship between FPG and T2D. Receiver operating characteristic (ROC) curves were used to evaluate the predictive power of FPG for T2D.ResultsThe mean age of the 220 104 participants (204 640 Chinese and 15 464 Japanese participants) was 41.8 years (41.7 years for the Chinese and 43.7 years for the Japanese participants). During follow-up, 2611 individuals developed T2D (2238 Chinese and 373 Japanese participants). The RCS demonstrated a J-shaped relationship between FPG and T2D risk, with inflexion points of 4.5 and 5.2 for the Chinese and Japanese populations, respectively. Multivariate-adjusted hazard ratio (HR) was 7.75 for FPG and T2D risk after the inflexion point (7.3 for Chinese and 21.13 for Japanese participants).ConclusionsIn general Chinese and Japanese populations, the normal baseline FPG range showed a J-shaped relationship with the risk of T2D. Baseline FPG levels help identify individuals at high risk of T2D and may enable early primary prevention to improve their outcomes.

Interaction effect between fasting plasma glucose and lipid profiles on mortality of peritoneal dialysis patients.

Peritoneal dialysis (PD) patients have a high risk of abnormal glucose and lipids metabolism. We investigated the effects of baseline fasting plasma glucose (FPG) as well as its interaction with lipid profiles on all-cause and cardiovascular disease (CVD) cause-specific mortality in PD patients. A total of 1995 PD patients were enrolled. Kaplan-Meier survival curves and Cox regression models were performed to assess the association of FPG levels with mortality in PD patients. During a median (25th-75th quartile) follow-up period of 48.1 (21.8-77.9) months, 567 (28.4%) patients died, including 282 (14.1%) CVD deaths. Kaplan-Meier survival curves showed that all-cause and CVD cause-specific mortality increased significantly with elevated baseline FPG levels (Log-rank tests: both P-values <.001). However, with adjustment for potential confounding factors, baseline FPG levels were not significantly associated with all-cause and CVD cause-specific mortality. Nevertheless, a significant interaction between baseline FPG and low-density lipoprotein cholesterol (LDL-C) on all-cause mortality was found (P for interaction test: .013), and subgroup analyses further showed that all-cause mortality was significantly increased for baseline FPG ≥7.0mmol/L compared with the normal reference (FPG <5.6mmol/L) (hazard ratio 1.89, 95% confidence interval 1.11-3.23, P-value=.020) for patients with LDL-C ≥3.37mmol/L only, but not for those with lower LDL-C levels (<3.37mmol/L). The significant interaction effect between baseline FPG and LDL-C on all-cause mortality showed that, for PD patients with LDL-C ≥3.37mmol/L, higher FPG levels (≥7.0mmol/L) were significantly associated with an increased risk of all-cause mortality and need more intensive management of their FPG by clinicians in the future.

Antipsychotic-Related Risks of Type 2 Diabetes Mellitus in Enrollees With Schizophrenia in the National Basic Public Health Service Program in Hunan Province, China.

BackgroundAntipsychotics contribute to the development of type 2 diabetes mellitus (T2DM) in individuals with schizophrenia. However, the extent of the relationship between antipsychotic use and T2DM varies in different settings, and the magnitude of the drug-specific effects fluctuates widely. This study aimed to explore the association of T2DM with antipsychotic use among enrollees with schizophrenia in China's National Basic Public Health Service Program (NBPHSP) and the drug-specific relationship with T2DM among patients receiving antipsychotic monotherapy.MethodsWe recruited diabetes-free patients with schizophrenia who were enrolled in the NBPHSP of Hunan Province from October 2009 to December 2018. The participants were classified into the following three groups: regular antipsychotic use, intermittent antipsychotic use, and antipsychotic-free groups. The patients were followed up until they received a T2DM diagnosis or until April 2019. Cox regression models were constructed to calculate the overall and drug-specific hazard ratios (HRs) to determine the antipsychotic–T2DM relationship. Interactive and subgroup analyses were performed to assess the heterogeneity of the effects across subgroups.ResultsA total of 122,064 NBPHSP enrollees with schizophrenia were followed up for 1,507,829 cumulative person-years, and 2,313 (1.89%) patients developed T2DM. Patients who regularly and intermittently used antipsychotics had 117% (HR: 2.17, 95% CI: 1.83–2.57) and 53% (HR: 1.53, 95% CI: 1.23–1.90) higher risks of developing T2DM than antipsychotic-free patients, respectively. Regarding monotherapy, the T2DM risk increased by 66, 80, 62, and 64% after the regular use of clozapine, risperidone, chlorpromazine, and perphenazine, respectively. In addition, the antipsychotic-related risk of T2DM decreased as the patient's baseline body mass index, and baseline fasting plasma glucose level, as well as the dietary proportion of animal products, increased.ConclusionAntipsychotics, especially clozapine, risperidone, chlorpromazine, and perphenazine, increased the T2DM risk among NBPHSP enrollees with schizophrenia. Mental health officers should accurately identify enrollees at a high risk of T2DM and take appropriate preventive measures to reduce the incidence of T2DM among patients with schizophrenia.

Efficacy of lifestyle intervention in adults with impaired glucose tolerance with and without impaired fasting plasma glucose: A post hoc analysis of Da Qing Diabetes Prevention Outcome Study.

The extent that pre-diabetic fasting plasma glucose (FPG) levels influence the effectiveness of lifestyle interventions in preventing type 2 diabetes (T2DM) is uncertain. We aimed to determine if the outcome of lifestyle intervention in people with impaired glucose tolerance (IGT) differs in those with normal or impaired FPG levels. Data were used from the Da Qing Diabetes Prevention Outcome Study, which was a 30-year follow-up of a 6-year randomized trial of lifestyle intervention in 576 people with IGT. We then conducted a post-hoc analysis to compare the efficacy of intervention to reduce the incidence of T2DM and its complications in those with baseline FPG <100 mg/dL and FPG ≥100 mg/dL. Lifestyle intervention reduced the cumulative incidence of T2DM by 37%-46% in those with baseline FPG <100 mg/dL and by 47%-51% in those with FPG ≥100 mg/dL. The FPG <100 mg/dL group had a lower cumulative incidence of diabetes and 6.41 years median delay in its onset compared with 2.21 years delay in the FPG ≥100 mg/dL group. In those with FPG <100 mg/dL intervention was associated with at least as great a reduction in cardiovascular disease and all-cause mortality as in the FPG ≥100 mg/dL group. Lifestyle intervention reduced the incidence of T2DM in people with IGT regardless of baseline FPG levels, and in those with FPG <100 mg/dL led to a substantial delay in its onset. All persons with IGT, with normal or impaired FPG levels, may benefit from lifestyle intervention to delay its onset and mitigate the incidence of T2DM.

Association of metabolic score for insulin resistance and its 6-year change with incident type 2 diabetes mellitus.

The evidence for the association between metabolic score for insulin resistance (METS-IR) and type 2 diabetes mellitus (T2DM) is limited. We aimed to explore the association of METS-IR and its 6-year change with risk of incident T2DM in a rural Chinese population. We analyzed data for 12 107 participants (mean age 50.48 years). A Cox proportional-hazard model was used to estimate the association of METS-IR with incident T2DM by using hazard ratios (HRs) and 95% confidence intervals (CIs); a logistic regression model was used to assess the association of 6-year METS-IR change with incident T2DM by using odds ratios (ORs) and 95% CIs. We used subgroup analyses of the association of METS-IR and its 6-year change with incident T2DM by sex, age, and baseline fasting plasma glucose (FPG) level as well as restricted cubic splines to describe the dose-response association. The association of METS-IR and 6-year METS-IR change with incident T2DM was significant (per SD unit increase: HR=1.80, 95% CI: 1.60-2.02 for METS-IR, OR=1.42, 95% CI: 1.28-1.57 and OR=1.59, 95% CI: 1.44-1.76 for relative and absolute METS-IR change). The significant association remained on subgroup analyses by sex, age, and baseline FPG level. Dose-response analysis demonstrated that the probability of incident T2DM was significantly increased with increasing METS-IR and 6-year METS-IR change. Increased METS-IR and 6-year METS-IR change were positively associated with risk of incident T2DM in a rural Chinese population. METS-IR may be a vital indicator for identifying T2DM.

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.

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.

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.

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.

Analysis of Risk Factors for Posttransplant Diabetes Mellitus After Kidney Transplantation: Single-Center Experience.

Posttransplant diabetes mellitus may severely affect the short-term and long-term outcomes of grafts and patient survival in kidney transplant recipients. The annual incidence rate of posttransplant diabetes mellitus ranges from 4% to 25%. In this study, our aim was to determine the possible risk factors in patients diagnosed with this disease. From November 1975 to May 2019, our transplant team performed 3012 kidney transplant procedures at different units within Baskent University Transplantation Centers. We retrospectively analyzed data of patients who were diagnosed with posttransplant diabetes mellitus between 2010 and 2019. The diagnosis was made according to the 2001 American Diabetes Association criteria (fasting plasma glucose level ≥ 126 mg/dL [7 mmol/L] in 2 measurements or random blood glucose level ≥ 200 mg/dL [11.1 mmol/L] within 12 months posttransplant). For this study, 400 patients (292 male, 108 female) with end-stage renal disease and without diabetes met the initial inclusion criteria; 270 received hemodialysis, 26 received peritoneal dialysis, and 104 underwent preemptive kidney transplant. In this patient group, 62 patients (15.5%) developed post-transplant diabetes mellitus. When we compared patients who developed and did not develop posttransplant diabetes mellitus, cause of end-stage renal disease, dialysis type and duration, type of donor (living or deceased), and graft survival posttransplant were similar between groups. Baseline fasting plasma glucose level was significantly higher in patients who developed posttransplant diabetes mellitus (90 vs 85 mg/dL; P = .034). Patients who developed the disease were significantly older. In our study, recipient age was the only risk factor for posttransplant diabetes mellitus. Older recipients should be examined more carefully for posttransplant diabetes mellitus, and less diabetogenic immunosuppressive drugs may be preferred.

Hyperglycemia and FEP: Does Migration Status Matter?

Background: Several evidence have shown hyperglycemia and diabetes are frequent in patients with psychoses. There are evidences that some ethnic minorities are at higher risk of psychosis. It is less clear if migration history is a risk factor for diabetes and hyperglycemia during first-episode psychosis (FEP). The present study aims to evaluate if migration history might influence fasting plasma glucose change during antipsychotic treatment (APs) in (FEP). Materials and Methods: We carried out a retrospective follow-up of all FEP drug na?ve patients at their first contact with Bologna West Community Mental Health Centres from January 2010 to December 2015. Blood tests carried out during the follow-up period were collated from clinical charts to evaluate the baseline fasting plasma glucose level upon starting APs treatment and at the time of follow-up. Out of 50 patients who had FEP during the recruitment period and consented to take part in the study, 25 cases had blood test results available at follow-up. We performed linear multivariate regression analysis to adjust the association between migrant status and fasting plasma glucose level of follow-up by gender, age, education, employment, APs treatment and dose. Results: At baseline, the mean fasting plasma glucose level was within the normal range and at follow-up we observed a significant increase in the mean fasting plasma glucose in migrants. Upon multivariate linear regression analysis, migration history remained significantly associated with the follow-up fasting plasma glucose level. Conclusions: In conclusion, we found that migrants with FEP are particularly at risk of developing hyperglycemia and type II diabetes during APs treatment.

Weight loss at your fingertips – personalized nutrition using fasting glucose and insulin

AbstractIntroductionPrecision medicine is changing the way people are diagnosed and treated into a more personalized approach. In medical research, several statistical methods have been proposed for estimating personalized treatment effects. However, in nutritional science these methods have hardly been used. By re-evaluation of pre-treatment biomarker data, we demonstrate how two diets cause differential weight loss depending on pre-treatment fasting plasma glucose (FPG) and fasting insulin (FI) levels.Materials and MethodsOverweight people with increased waist circumference were randomly assigned to receive an ad libitum New Nordic Diet (NND) high in dietary fiber and whole grain or an Average Danish (Western) Diet (ADD) for 26 weeks. All foods were provided free of charge. Body weight was measured throughout the study and blood was drawn before randomization from where FPG and FI were analyzed. Weight was described by linear mixed models including biomarker-diet group interactions, covariate adjustment, and participant-specific random effects. Personalized predictions of additional weight loss from NND compared to ADD given specific values of FPG or FI were estimated as contrasts of intercepts and slopes obtained from the biomarker-diet group interaction term.ResultsBaseline FPG predicted a 3.00 (1.18;4.83, n = 181, P = 0.001) kg larger weight loss per mmol/L from choosing NND over ADD. For instance, a baseline FPG level of 4.7 mmol/L would lead to an average of 1.42 kg larger weight loss on NND vs. ADD (above 0.41 kg with 95% certainty), whereas the average effect size would be 8.33 kg (above 5.50 kg with 95% certainty) among subjects with FPG level of 7.0 mmol/L. Among individuals with FPG &lt; 5.6 mmol/L, each pmol/L lower baseline FI predicted a 0.039 (95% CI 0.017;0.061, n = 143, P &lt; 0.001) kg larger weight loss from choosing NND over ADD. For instance, a baseline FI level of 25 pmol/L would lead to an average larger weight loss of 4.10 kg on NND vs. ADD (&gt; 2.51 kg with 99% certainty). Likewise, a baseline FI level of 75 pmol/L would result in an average effect size of 2.15 kg (&gt; 1.11 kg with 99% certainty).DiscussionUse of pre-treatment FPG and FI led to truly individualized predictions of treatment effect of introducing more fiber and whole grain in the diet on weight loss, ranging from almost no effect to losing more than 8 kg. These findings tentatively suggest that re-evaluation of data from existing randomized controlled trials through suitable statistical methods may have a great potential.

Effect of Rosuvastatin on fasting plasma glucose after coronary stent implantation in elderly patients

Objective To investigate the effect of Rosuvastatin on fasting plasma glucose after coronary stent implantation in elderly patients with non-diabetes mellitus. Methods A total of 216 non-diabetic elderly patients undergoing coronary stent implantation in our hospital from November 2015 to April 2018 were enrolled, with a follow-up in the cardiovascular department after discharge from the Hospital.The demographic data, follow-up time, and laboratory results at hospital admission and the last outpatient visit were collected retrospectively. Results At the end of follow-up, Fasting plasma glucose(FPG)was increased in 191 patients with normal baseline FPG level as compared with the baseline level(t=-3.783, P=0.000). The incidence of new-onset diabetes was higher in the pre-diabetes group than in the normal blood glucose group(24.0% vs.2.6%, χ2=16.72, P=0.000). Conclusions Rosuvastatin increases fasting blood glucose levels in elderly non-diabetic patients after coronary stent implantation.Pre-diabetes may increase the risk for rosuvastatin-associated new-onset diabetes. Key words: Coronary artery disease; Blood glucose

SAT-LB023 Elevated Fasting Plasma Glucose Predicts Higher Odds For Becoming A Super-responder With Gelesis100 In The GLOW Pivotal Weight-loss Study

Background: In a previous pilot weight-loss study, an association was observed between baseline fasting plasma glucose (FPG) levels and the effectiveness of the Gelesis100 treatment. The aim of this subanalysis of the Gelesis Loss Of Weight (GLOW; NCT02307279) study is to further assess the association between FPG and body weight (BW) responders in subjects with overweight or obesity treated with Gelesis100, a non-systemic hydrogel. Methods: This subanalysis was conducted in subjects who were overweight or had obesity and who completed the GLOW study. GLOW was a multicenter, double-blind, placebo-controlled pivotal study with subjects randomized to 2.25 g of Gelesis100 or placebo in capsules taken with 500 mL of water before lunch and dinner while on a hypocaloric diet (-300 kcal/day) for 24 weeks. BW responders at 5% and 10% (super-responders) were analyzed using Logit model comparing Gelesis100 to placebo arms in 2 subgroups of subjects defined by their initial FPG (two consecutive consistent values). Subgroup 1 had normoglycemia (FPG < 100 mg/dL) and subgroup 2 had prediabetes (PD) (FPG ≥ 100 mg/dL and < 126 mg/dL) or untreated type 2 diabetes (T2D) (FPG ≥ 126 mg/dL). Results: The population included 206 subjects (94 males, 112 females, 138 in subgroup 1, 68 in subgroup 2, 105 on Gelesis100, 101 on placebo). In subgroup 1 (mean baseline FPG = 91 mg/dL), BW responders at 5% and 10% in Gelesis100 arm were 60% (placebo arm = 34%, adjusted odds ratio (OR) = 3.1, P = 0.0022) and 22% (placebo arm = 15%, OR = 1.5, P = 0.4254), respectively. In subgroup 2 (mean baseline FPG = 113 mg/dL), BW responders at 5% and 10% in Gelesis100 arm were 72% (placebo arm = 56%, OR = 2.2, P = 0.1509) and 44% (placebo arm = 14%, OR = 6.1, P = 0.0071), respectively. In the overall population, baseline FPG was inversely correlated with BW percent change in the Gelesis100 arm (r = -0.24, P = 0.0144). The safety and tolerability of Gelesis100 demonstrated no increased risk compared to placebo. No serious adverse events were observed in any arm. Conclusion: Gelesis100 offers a compelling new approach in the management of overweight and obesity. Notably, in Gelesis100-treated subjects with PD or untreated T2D, the odds of being super-responders are 6 times higher compared to placebo. This finding may be used as a tool for identifying subjects who are both at higher clinical risk and more likely to achieve greater levels of BW loss when treated with Gelesis100. The mechanisms underlying this finding require further investigations. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

Weight loss at your fingertips: personalized nutrition with fasting glucose and insulin using a novel statistical approach.

Precision medicine is changing the way people are diagnosed and treated into a more personalized approach. Using a novel statistical approach, we demonstrate how two diets cause differential weight loss depending on pre-treatment fasting plasma glucose (FPG) and fasting insulin (FI) levels. One hundred and eighty-one overweight people with increased waist circumference were randomly assigned to receive an ad libitum New Nordic Diet (NND) high in dietary fiber and whole grain or an Average Danish (Western) Diet (ADD) for 26 weeks. All foods were provided free of charge. Body weight was measured throughout the study and blood was drawn before randomization from where FPG and FI were analyzed. Weight was described by linear mixed models including biomarker (FPG or FI) diet group interactions. Individualized predictions were estimated as contrasts of intercepts and slopes of pre-treatment biomarkers. Every mmol/L increase in baseline FPG predicted a between-diet difference of 3.00 (1.18;4.83, n = 181, P = 0.001) kg larger weight loss from choosing NND over ADD. For instance, a baseline FPG level of 4.7 mmol/L would lead to an average of 1.42 kg larger weight loss on NND vs. ADD (above 0.41 kg with 95% certainty), whereas the average effect size would be 8.33 kg (above 5.50 kg with 95% certainty) among subjects with FPG level of 7.0 mmol/L. Among individuals with FPG <5.6 mmol/L, each pmol/L lower baseline FI predicted a 0.039 (95% CI 0.017;0.061, n = 143, P < 0.001) kg larger weight loss from choosing NND over ADD. Use of pre-treatment FPG and FI led to truly individualized predictions of treatment effect of introducing more fiber and whole grain in the diet on weight loss, ranging from almost no effect to losing >8 kg. These findings suggest that this novel statistical approach has great potential when re-evaluating data from existing randomized controlled trials.

Symptomatic and silent cerebral ischemia (detected on MRI) in patients with type 2 diabetes mellitus after carotid revascularization procedures

Background: Type 2 diabetes mellitus (T2DM) is a significant independent risk factor for ischaemic stroke. Carotid revascularisation procedures are an effective method of primary and secondary stroke prevention. However, patients developed postoperative acute ischaemic lesions (AILs), which were identified via magnetic resonance imaging (MRI) of the brains. Most of the patients with these AILs lack clinically overt symptoms.&#x0D; Aims: To assess the risk of ischaemic brain damage in patients with T2DM in the setting of carotid angioplasty with stenting (CAS) or carotid endarterectomy (CAE).&#x0D; Materials and methods: This open prospective study comprised of 164 patients with carotid atherosclerosis, who have undergone either CAS or CAE. Patients with T2DM were included in Group 1: 38 patients and 28 patients with CAE. Group 2 included patients without T2DM: 62 patients with CAS and 36 patients with CAE. All patients underwent a thorough neurological examination and diffusion-weighted brain MRI. In patients with T2DM, plasma glucose levels and glycated haemoglobin (HbA1c) were determined and their relationships to brain damage were evaluated.&#x0D; Results: In CAS, there were no statistically significant differences in the AIL frequency in patients with and without T2DM. AILs were found in 15 patients with T2DM (39.8%) and 29 patients without T2DM (46.8%, р = 0.24); three patients without T2DM were diagnosed with stroke. Of the 28 patients with T2DM who underwent CAE, 13 had AIL (46.4%); three had stroke (10.7%). In patients without T2DM, AILs were less prevalent in seven cases (19.4%, р = 0.012) and appeared asymptomatic. Following CAS, the baseline HbA1c levels were higher in patients with T2DM who developed AILs compared to those who did not develop AIL, 7.8% 1.4% vs 7.1 1.1% (р = 0.0469). Negative impact of hyperglycaemia on the risk of cerebral ischaemia was observed in patients who underwent CAE, the baseline fasting plasma glucose level was 8.5 1.9 mmol/l vs 7.0 1.5 mmol/l in patients without AIL (р = 0.014). The baseline HbA1c levels in patients with and without AILs were 8.0% 1.7% and 6.9% 0.9% respectively (р = 0.023).&#x0D; Conclusions: Carotid revascularisation procedure for patients with carotid atherosclerosis may be associated with risk of stroke and asymptomatic acute cerebral ischaemic lesions, which are more prevalent in patients with T2DM. Also, increased HbA1c levels is a risk factor for AIL.

Symptomatic and silent cerebral ischemia (detected on MRI) in patients with type 2 diabetes mellitus after carotid revascularization procedures

Background : Type 2 diabetes mellitus (T2DM) is a significant independent risk factor for ischaemic stroke. Carotid revascularisation procedures are an effective method of primary and secondary stroke prevention. However, patients developed postoperative acute ischaemic lesions (AILs), which were identified via magnetic resonance imaging (MRI) of the brains. Most of the patients with these AILs lack clinically overt symptoms. Aims : To assess the risk of ischaemic brain damage in patients with T2DM in the setting of carotid angioplasty with stenting (CAS) or carotid endarterectomy (CAE). Materials and methods : This open prospective study comprised of 164 patients with carotid atherosclerosis, who have undergone either CAS or CAE. Patients with T2DM were included in Group 1: 38 patients and 28 patients with CAE. Group 2 included patients without T2DM: 62 patients with CAS and 36 patients with CAE. All patients underwent a thorough neurological examination and diffusion-weighted brain MRI. In patients with T2DM, plasma glucose levels and glycated haemoglobin (HbA1c) were determined and their relationships to brain damage were evaluated. Results : In CAS, there were no statistically significant differences in the AIL frequency in patients with and without T2DM. AILs were found in 15 patients with T2DM (39.8%) and 29 patients without T2DM (46.8%, р = 0.24); three patients without T2DM were diagnosed with stroke. Of the 28 patients with T2DM who underwent CAE, 13 had AIL (46.4%); three had stroke (10.7%). In patients without T2DM, AILs were less prevalent in seven cases (19.4%, р = 0.012) and appeared asymptomatic. Following CAS, the baseline HbA1c levels were higher in patients with T2DM who developed AILs compared to those who did not develop AIL, 7.8% ± 1.4% vs 7.1 ± 1.1% (р = 0.0469). Negative impact of hyperglycaemia on the risk of cerebral ischaemia was observed in patients who underwent CAE, the baseline fasting plasma glucose level was 8.5 ± 1.9 mmol/l vs 7.0 ± 1.5 mmol/l in patients without AIL (р = 0.014). The baseline HbA1c levels in patients with and without AILs were 8.0% ± 1.7% and 6.9% ± 0.9% respectively (р = 0.023). Conclusions : Carotid revascularisation procedure for patients with carotid atherosclerosis may be associated with risk of stroke and asymptomatic acute cerebral ischaemic lesions, which are more prevalent in patients with T2DM. Also, increased HbA1c levels is a risk factor for AIL.

Incidence of Diabetes in the Working Population in Spain: Results from the ICARIA Cohort.

IntroductionOur objective was to evaluate the incidence of type 2 diabetes mellitus (T2DM) in a working population in Spain and to assess associations between its development and several risk factors.MethodsThe ICARIA (Ibermutuamur CArdiovascular RIsk Assessment) cohort (n = 627,523) includes ~3% of Spanish workers. This analysis was undertaken in individuals whose glycaemic status during the index period (May 2004–December 2007) was determined to be normal or indicative of prediabetes [fasting plasma glucose (FPG) 100–125 mg/dl] and who had at least one FPG measurement taken 9 months after a first measurement during follow-up (May 2004–June 2014) (n = 380,366). T2DM patients were defined as those with an FPG ≥ 126 mg/day and those who had already been diagnosed with T2DM or were taking antihyperglycaemic medications.ResultsThe incidence rate of T2DM was 5.0 [95% confidence interval (CI) 4.9–5.1] cases per 1000 person-years. Under multivariate logistic regression analysis, the factor showing the strongest association with the occurrence of T2DM was the baseline FPG level, with the likelihood of T2DM almost doubling for every 5 mg/dl increase in baseline FPG between 100 and < 126 mg/dl. The presence of other cardiometabolic risk factors and being a blue-collar worker were also significantly associated with the occurrence of T2DM.ConclusionsThe incidence of T2DM in the working population was within the range encountered in the general population and prediabetes was found to be the strongest risk factor for the development of diabetes. The workplace is an appropriate and feasible setting for the assessment of easily measurable risk factors, such as the presence of prediabetes and other cardiometabolic factors, to facilitate the early detection of individuals at higher risk of diabetes and the implementation of diabetes prevention programmes.FundingEli Lilly and Co.

Risk of new-onset diabetes mellitus during treatment with low-dose statins in Japan: A retrospective cohort study.

The risk of new-onset diabetes mellitus (NODM) in Japanese patients using low-dose hydroxymethyl glutaryl coenzyme A reductase inhibitors (statins) has not been previously examined. The aim of this study was to assess the risk of NODM associated with use of high- and low-potency statins in Japanese patients taking low-dose statins. A retrospective cohort study of 2554 Japanese patients who started treatment with a statin was conducted. Only patients taking the same dose of the same statin were enrolled, and patients were separated into high- and low-potency statin groups. The outcome was incidence of NODM during statin treatment. The incidence rate of NODM in the cohort was 7.4% (n=190). Kaplan-Meier survival curves showed a significantly higher rate of NODM in patients taking high-potency statins compared with those taking low-potency statins (P<.001, log-rank test). Baseline fasting plasma glucose levels, use of high-potency statins, male gender and combination treatment with calcium channel blockers, immunosuppressants or steroids were identified as factors that significantly increased the risk for NODM using Cox proportional hazard regression analysis. The use of high-potency statins at a low standard daily dose significantly increased the risk of NODM in Japanese patients compared with low-potency statins. Furthermore, clinicians should also be careful when prescribing statins in combination with steroids or immunosuppressants due to the increased risk of NODM.

Quality-of-life and treatment satisfaction in actual clinical practice of patients with Type 1 diabetes mellitus (T1DM) and hypoglycemia treated with insulin degludec

Objective: The frequency of hypoglycemia in patients with T1DM is high and results in a poorer quality-of-life and low treatment satisfaction. The aim of this study is to demonstrate the effect of changing the basal insulin (glargine or detemir) to insulin degludec.Methods: An observational analytical study was conducted on a cohort of 110 patients with T1DM. The patients were administered three questionnaires to assess treatment satisfaction (DTSQ-s), fear of hypoglycemia (HFS-II) and quality-of-life (EQ-5D), before the change and at 6 months. A statistical analysis was performed for repeated measures.Results: The 110 patients with T1DM had a mean diabetes duration of 19.1 (11.6) years, 53.6% were men, the mean age was 43.4 (15.4) years, and the mean BMI was 25.2 (4.2) kg/m2. After 6 months, there was a significant reduction in baseline fasting plasma glucose (from 159.1 [68.6] to 132.9 [56.6] mg/dL; p < .001) and HbA1c levels (from 7.82% [1.2] to 7.6% [1.2]; p = .002). A reduction in the number of severe hypoglycemic episodes (0.17 [0.5] vs 0.05 [0.2]; p = .03) was observed. At 6 months, an improvement in the DTSQ-s (from 24.3 [5.5] to 27.3 [5.4]; p < .001) was observed. There was a decrease in the mean number of perceived hypoglycemia (from 2.9 [1.4] to 2.3 [1.4]; p = .003) and hyperglycemia (from 3.5 [1.3] to 2.7 [1.4]; p < .001). There was also a decrease in the mean HFS-II score (from 24.1 [14.0] to 20.0 [13.0]; p < .001). There were no significant differences in the EQ-5D index (from 0.91 [0.14] to 0.89 [0.16]; p = .13). However, there was significant improvement in the EQ-5D as measured by VAS (from 70.5 [16.5] to 73.6 [14.4]; p = .04).Conclusions: The change to insulin degludec in patients with T1DM improved their metabolic control, increased their satisfaction with the insulin therapy, and offered them improved quality-of-life.