The study of metabolic improvement by nutritional intervention controlling endogenous GIP (Mini Egg study): a randomized, cross-over study.

BACKGROUND: Given the major role of glucose-dependent insulinotropic polypeptide (GIP) in the regulation of adiposity, this study examined the effects induced by a diet based on the Japanese tradition (SMART WASHOKU) on the visceral fat area (VFA) and GIP secretions. METHODS: Overweight/obese men (n = 21; mean age, 41.0 ± 9.0 years; mean BMI, 25.2 ± 2.0 kg/m2) without diabetes were placed on either a SMART WASHOKU or control meal for 2 weeks, in a randomized, cross-over setup with a four-week washout period. RESULTS: For the meal tolerance test, blood samples were collected at 0, 30, 60, 120, 180, and 240 min post-meal, followed by measuring blood glucose, insulin, GIP, and glucagon-like peptide-1 (GLP-1) levels. Relative to a control meal, SMART WASHOKU meal yielded significantly lower plasma postprandial GIP concentrations (AUC: 700.0 ± 208.0 vs. 1117.0 ± 351.4 pmol/L・4 h, P < 0.05); however, between meals, there was no significant difference in the levels of GLP-1, peptide YY, and ghrelin. Compared to the control meal, SMART WASHOKU intervention significantly reduced VFA and the levels of LDL-cholesterol, triglyceride, and HbA1c after the chronic meal intervention. CONCLUSIONS: In conclusion, a SMART WASHOKU meal may decrease VFA and improve metabolic parameters in overweight/obese men, possibly via suppressing GIP secretion.

Association of scan frequency with CGM-derived metrics and influential factors in adults with type 1 diabetes mellitus.

Introduction: This study aimed to investigate the association between scan frequency and intermittently scanned continuous glucose monitoring (isCGM) metrics and to clarify the factors affecting scan frequency in adults with type 1 diabetes mellitus (T1D). Methods: We enrolled adults with T1D who used FreeStyle® Libre. Scan and self-monitoring of blood glucose (SMBG) frequency and CGM metrics from the past 90-day glucose data were collected. The receiver operating characteristic curve was plotted to obtain the optimal cutoff values of scan frequency for the target values of time in range (TIR), time above range (TAR), and time below range (TBR). Results: The study was conducted on 211 adults with T1D (mean age, 50.9 ± 15.2 years; male, 40.8%; diabetes duration, 16.4 ± 11.9 years; duration of CGM use, 2.1 ± 1.0 years; and mean HbA1c, 7.6 ± 0.9%). The average scan frequency was 10.5 ± 3.3 scan/day. Scan frequency was positively correlated with TIR and negatively correlated with TAR, although it was not significantly correlated with TBR. Scan frequency was positively correlated with the hypoglycemia fear survey-behavior score, while it was negatively correlated with some glycemic variability metrics. Adult patients with T1D and good exercise habits had a higher scan frequency than those without exercise habits. The AUC for > 70% of the TIR was 0.653, with an optimal cutoff of 11 scan/day. Conclusions: In real-world conditions, frequent scans were linked to improved CGM metrics, including increased TIR, reduced TAR, and some glycemic variability metrics. Exercise habits and hypoglycemia fear-related behavior might affect scan frequency. Our findings could help healthcare professionals use isCGM to support adults with T1D.Clinical Trial Registry No. UMIN000039376.

Association of a pro-inflammatory diet and gestational diabetes mellitus with maternal anemia and hemoglobin levels during pregnancy: a prospective observational case-control study.

Anemia is prevalent in pregnant women, and the causes include inadequate diet, increased demand for iron, and inflammation. We hypothesized that gestational diabetes mellitus (GDM) and hepcidin-related gene polymorphisms may contribute to maternal anemia and that an anti-inflammatory diet can alleviate this negative effect. The aim of this study was to investigate the association of an inflammatory diet, GDM, and single nucleotide polymorphisms (SNPs) in hepcidin-related genes, which are key regulators of iron, with maternal anemia. This was a secondary data analysis of a prospective prenatal diet and pregnancy outcome study in Japan. The Energy-Adjusted Dietary Inflammatory Index was calculated using a brief self-administered diet history questionnaire. We analyzed 121 SNPs in 4 genes: TMPRS6 (43 SNPs), TF (39 SNPs), HFE (15 SNPs), and MTHFR (24 SNPs). Multivariate regression analysis was conducted to determine the association between the first variable and maternal anemia. The prevalence of anemia in first, second, and third trimesters were 5.4%, 34.9%, and 45.8%, respectively. The pregnant women with GDM had a significantly higher incidence of moderate anemia than those without GDM (40.0% vs. 11.4%, P = .029). In multivariate regression analysis, Energy-adjusted Dietary Inflammatory Index (ß = -0.057, P = .011) and GDM (ß = -0.657, P = .037) were significantly associated with hemoglobin levels during the third trimester. Using Stata's qtlsnp command, TMPRSS6 rs2235321 was found to be associated with hemoglobin levels during the third trimester. These results indicate that inflammatory diets, GDM, and TMPRSS6 rs2235321 polymorphism are associated with maternal anemia. This result suggests that a pro-inflammatory diet and GDM are associated with maternal anemia.

The Effect of a mHealth App (KENPO-app) for Specific Health Guidance on Weight Changes in Adults With Obesity and Hypertension: Pilot Randomized Controlled Trial.

BACKGROUND: Commercial smartphone apps that promote self-monitoring of weight loss are widely available. The development of disease-specific apps has begun, but there is no app for specific health guidance (SHG) to prevent metabolic syndrome, type 2 diabetes, and cardiovascular diseases in middle-aged adults in Japan. OBJECTIVE: This study aimed to determine the efficacy of an SHG mobile health app in facilitating weight loss in Japanese adults with obesity and hypertension. METHODS: In a 12-week, statistician-blinded, randomized parallel controlled trial, 78 overweight and obese men aged 40-69 years were assigned in a 1:1 ratio to either the usual support plus KENPO-app group (intervention group) or the active control group. KENPO-app (release April 10, 2019; OMRON Healthcare Co., Ltd.) was developed by the study team and focus groups and uses behavior change techniques (ie, self-monitoring and goal-setting theory). This app was developed for SHG based on the four specific health checkups and guidance system in Japan: (1) focusing primarily on achieving the target (weight loss of ≥2 kg); (2) assessing healthy eating, exercise habits, smoking habits, relaxation, and self-weighing; (3) providing information on the results of specific health checkups; and (4) starting an intervention period of 6 months with the interim assessment at 3 months. The initial assessment explored the following: personality traits (4 types), health checkup data concerns (10 items), symptom concerns (10 items), and the aim of the intervention (weight loss, improving fitness, symptoms, laboratory data). Chatbot-supported health information on health and health behavior was selected from 392 quizzes based on app data and was provided to participants. The KENPO-app had chatbot-supported feedback and information provision combined with a self-monitoring tool (weight, steps, and blood pressure). Data on active exercise, healthy eating, and healthy lifestyle habits were obtained using a web-based self-administered questionnaire at baseline and 12 weeks. RESULTS: The trial's retention rate was 95% (74/78). The adherence to daily self-weighing, wearing the pedometer, and blood pressure monitoring in the KENPO-app group was significantly higher than those in the active control group. Compared with the active control group, the median body weight and BMI of the intervention group significantly decreased at 3 months (-0.4, IQR -2.0 to 0.6 kg vs -1.1, IQR -2.7 to -0.5 kg; P=.03; -0.1, IQR -0.6 to 0.3 kg vs -0.4, IQR -0.8 to -0.2 kg; P=.02, respectively). The intervention increased the percentage of participants who self-reported taking ≥8000 steps, eating vegetables before rice, eating slowly, and relaxing. Personality traits were associated with the degree of weight loss in the intervention group. CONCLUSIONS: The SHG-specific KENPO-app was feasible and induced modest but significant weight loss in adults with obesity. TRIAL REGISTRATION: University Hospital Medical Information Network Center UMIN000046263; https://tinyurl.com/bderys3b.

Optimization of nutritional strategies using a mechanistic computational model in prediabetes: Application to the J-DOIT1 study data.

Lifestyle interventions have been shown to prevent or delay the onset of diabetes; however, inter-individual variability in responses to such interventions makes lifestyle recommendations challenging. We analyzed the Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1) study data using a previously published mechanistic simulation model of type 2 diabetes onset and progression to understand the causes of inter-individual variability and to optimize dietary intervention strategies at an individual level. J-DOIT1, a large-scale lifestyle intervention study, involved 2607 subjects with a 4.2-year median follow-up period. We selected 112 individuals from the J-DOIT1 study and calibrated the mechanistic model to each participant's body weight and HbA1c time courses. We evaluated the relationship of physiological (e.g., insulin sensitivity) and lifestyle (e.g., dietary intake) parameters with variability in outcome. Finally, we used simulation analyses to predict individually optimized diets for weight reduction. The model predicted individual body weight and HbA1c time courses with a mean (±SD) prediction error of 1.0 kg (±1.2) and 0.14% (±0.18), respectively. Individuals with the most and least improved biomarkers showed no significant differences in model-estimated energy balance. A wide range of weight changes was observed for similar model-estimated caloric changes, indicating that caloric balance alone may not be a good predictor of body weight. The model suggests that a set of optimal diets exists to achieve a defined weight reduction, and this set of diets is unique to each individual. Our diabetes model can simulate changes in body weight and glycemic control as a result of lifestyle interventions. Moreover, this model could help dieticians and physicians to optimize personalized nutritional strategies according to their patients' goals.

To Use or Not to Use a Self-monitoring of Blood Glucose System? Real-world Flash Glucose Monitoring Patterns Using a Cluster Analysis of the FGM-Japan Study.

Objective This study investigated self-monitoring of blood glucose (SMBG) adherence and flash glucose monitoring patterns using a cluster analysis in Japanese type 1 diabetes (T1D) patients with intermittently scanned continuous glucose monitoring (isCGM). Methods We measured SMBG adherence and performed a data-driven cluster analysis using a hierarchical clustering in T1D patients from Japan using the FreeStyle Libre system. Clusters were based on three variables (testing glucose frequency and referred Libre data for hyperglycemia or hypoglycemia). Patients We enrolled 209 participants. Inclusion criteria were patients with T1D, duration of isCGM use ≥3 months, age ≥20 years old, and regular attendance at the collaborating center. Results The rate of good adherence to SMBG recommended by a doctor was 85.0%. We identified three clusters: cluster 1 (low SMBG test frequency but high reference to Libre data, 17.7%), cluster 2 (high SMBG test frequency but low reference to Libre data, 34.0%), and cluster 3 (high SMBG test frequency and high reference to Libra data, 48.3%). Compared with other clusters, individuals in cluster 1 were younger, those in cluster 2 had a shorter Libre duration, and individuals in cluster 3 had lower time-in-range, higher severe diabetic distress, and high intake of snacks and sweetened beverages. There were no marked differences in the incidence of diabetic complications and rate of wearing the Libre sensor among the clusters. Conclusion We stratified the patients into three subgroups with varied clinical characteristics and CGM metrics. This new substratification might help tailor diabetes management of patients with T1D using isCGM.

Association of Impaired Awareness of Hypoglycemia with Driving Safety and Hypoglycemia Problem-solving Abilities among Patients with Type 1 Diabetes in Japan: The PR-IAH Study.

Objective Patients with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) are at an elevated risk of experiencing automobile accidents. We therefore investigated the association of IAH with driving safety and hypoglycemia problem-solving abilities in adults with T1D. Methods This cross-sectional survey used Gold's method in adult patients with T1D at the National Hospital Organization (NHO) Hospital from February 14, 2020, to October 31, 2021. The participants were divided into control and IAH groups. The data included information on demographics, worries and distress regarding hypoglycemia, hypoglycemia problem-solving abilities, and adverse driving events. Patients We enrolled 233 participants (mean age: 48.5±12.8 years old, mean hemoglobin A1c level: 7.6%±0.9%) from NHO collaborating centers in Japan. Results Among a total of 233 participants (mean age: 48.5±12.8 years old, mean hemoglobin A1c level: 7.6%±0.9%), the prevalence rate of IAH was 11.6% [95% confidence interval (CI): 7.8-16.4%]. IAH was significantly associated with near-miss car accidents (odds ratio: 5.41; 95% CI:1.64-17.80). Diabetic peripheral neuropathy was associated with an increased risk of IAH, while treatment with continuous subcutaneous insulin infusion was not associated with a decreased risk of IAH. The average hypoglycemia problem-solving perception, detection control, and seeking preventive strategies scores in the IAH group were significantly reduced compared with those in the control group. Conclusion IAH was associated with an increased risk of near-miss car accidents among adults with T1D. Furthermore, good hypoglycemia problem-solving abilities were associated with a decreased risk of IAH.

Protective and risk factors of impaired awareness of hypoglycemia in patients with type 1 diabetes: a cross-sectional analysis of baseline data from the PR-IAH study.

BACKGROUND: Hypoglycemia in type 1 diabetes (T1D) is associated with mortality and morbidity, especially when awareness of hypoglycemia is impaired. This study aimed to investigate the protective and risk factors for impaired awareness of hypoglycemia (IAH) in adults with T1D. METHODS: This cross-sectional study enrolled 288 adults with T1D (mean age, 50.4 ± 14.6 years; male, 36.5%; diabetes duration, 17.6 ± 11.2 years; mean HbA1c level, 7.7 ± 0.9%), who were divided into IAH and non-IAH (control) groups. A survey was conducted to assess hypoglycemia awareness using the Clarke questionnaire. Diabetes histories, complications, fear of hypoglycemia, diabetes distress, hypoglycemia problem-solving abilities, and treatment data were collected. RESULTS: The prevalence of IAH was 19.1%. Diabetic peripheral neuropathy was associated with an increased risk of IAH (odds ratio [OR] 2.63; 95% confidence interval [CI] 1.13-5.91; P = 0.014), while treatment with continuous subcutaneous insulin infusion and hypoglycemia problem-solving perception scores were associated with a decreased risk of IAH (OR, 0.48; 95% CI, 0.22-0.96; P = 0.030; and OR, 0.54; 95% CI, 0.37-0.78; P = 0.001, respectively). There was no difference in continuous glucose monitoring use between the groups. CONCLUSION: We identified protective factors in addition to risk factors for IAH in adults with T1D. This information may help manage problematic hypoglycemia. TRIAL REGISTRATION: University hospital Medical Information Network (UMIN) Center: UMIN000039475). Approval date 13 February 2020.

Factors associated with hemoglobin glycation index in adults with type 1 diabetes mellitus: The FGM-Japan study.

AIMS/INTRODUCTION: The discrepancy between HbA1c and glucose exposure may have significant clinical implications; however, the association between the hemoglobin glycation index (HGI) and clinical parameters in type 1 diabetes remains controversial. This study aimed to find the factors associated with HGI (laboratory HbA1c - predicted HbA1c derived from the continuous glucose monitoring [CGM]). MATERIALS AND METHODS: We conducted a cross-sectional study of adults with type 1 diabetes (n = 211, age 50.9 ± 15.2 years old, female sex = 59.2%, duration of CGM use = 2.1 ± 1.0 years). All subjects wore the CGM for 90 days before HbA1c measurement. Data derived from the FreeStyle Libre sensor were used to calculate the glucose management indicator (GMI) and glycemic variability (GV) parameters. HGI was defined as the difference between the GMI and the laboratory HbA1c levels. The participants were divided into three groups according to the HGI tertile (low, moderate, and high). Multivariate regression analyses were performed. RESULTS: The female sex ratio, HbA1c, and % coefficient of variation (%CV) significantly increased over the HGI tertile, while eGFR and Hb decreased over the HGI tertile. In multivariate analysis, the factors associated with HGI were %CV and eGFR, after adjusting for HbA1c level and sex (R2  = 0.44). CONCLUSIONS: This study demonstrated that HGI is associated with female sex, eGFR, and some glycemic variability indices, independently of HbA1c. Minimizing glycemic fluctuations might reduce HGI. This information provides diabetic health professionals and patients with personalized diabetes management for adults with type 1 diabetes.

The Hepcidin-25/Ferritin Ratio Is Increased in University Rugby Players with Lower Fat Mass.

Hepcidin-25 is suggested as a surrogate iron status marker in athletes who show exercise-induced anemia; however, the implications of hepcidin concentration in this population remain poorly understood. This study aimed to investigate the relationship between hepcidin and body fat levels in rugby football players. We included 40 male university rugby football players (RUG) and 40 non-athlete controls. All participants underwent an anthropometric analysis and blood testing that included both hepcidin-25 and ferritin levels. The hepcidin-25 level was slightly (11.6%, p = 0.50) higher, and the ferritin level was significantly (35.9%, p < 0.05) lower, in the RUG group than in controls. The hepcidin-25 to-ferritin ratio was significantly higher (62.5%, p < 0.05) in the RUG group. While significant U-shaped correlations were observed between the body fat and ferritin levels in both groups, the correlations between the hepcidin levels and fat mass index were significantly higher in the RUG group (RUG: r = 0.79, controls: r = 0.45). Notably, the RUG with the lower fat mass index group had a higher hepcidin-25 level, lower ferritin level, and then significantly higher hepcidin-25/ferritin ratio. The hepcidin-25/ferritin ratio may serve as a biomarker for iron status in RUG, especially RUG with lower fat mass.

Impact of telephone support programme using telemonitoring on stage of change towards healthy eating and active exercise in people with prediabetes.

INTRODUCTION: This study evaluated the impact of a telephone support programme with telemonitoring on changes in healthy eating and active exercise in adults with prediabetes using the stage of change framework. METHODS: We performed a post hoc analysis using data from the Japan Diabetes Outcome Trial-1. A total of 2607 participants aged 20-65 years with impaired fasting glucose were recruited from the workplace/community in Japan and randomized to a one year telephone support programme intervention arm (n = 1240) or self-directed control arm (n = 1367). Participants in both arms received monthly data feedback from a weight scale and pedometer. The main outcome measure was the stages of change toward healthy eating and active exercise. The secondary outcome was fasting plasma glucose (FPG). RESULTS: After the one year intervention, the adjusted odds ratio of progressing to the action/maintenance stage in the intervention vs. control arm for healthy eating was 1.31 (95% confidence interval (CI) 1.21-1.43; p < 0.001), but that for active exercise was 1.07 (95% CI 0.99-1.15; p = 0.062). The intervention decreased FPG levels in participants in the contemplation stage, but not in the precontemplation, preparation and action/maintenance stages. DISCUSSION: These findings suggest that the telephone support programme by healthcare providers advanced the stage of changes toward healthy eating in people with prediabetes. In particular, it decreased FPG levels in the contemplation stage.

Predictive Factors of the Adherence to Real-Time Continuous Glucose Monitoring Sensors: A Prospective Observational Study (PARCS STUDY).

BACKGROUND: Information about factors related to better adherence to continuous glucose monitoring (CGM) sensor adherence is quite limited. MATERIALS AND METHODS: Forty-six participants with type 1 diabetes using continuous subcutaneous insulin infusion (CSII) without CGM were recruited. The participants' characteristics and diabetes-related quality of life (QOL) were evaluated at baseline and one year after starting to use CGM. Participants wearing the sensor for ≥60% of the time were considered as adherent. RESULTS: The mean age of the 46 participants was 44.1 ± 15.0 years old and the mean glycohemoglobin (HbA1c) was 7.7 ± 1.0%; 60.9% of the participants were classified as adherent. The duration of using CSII was longer in the adherent group, and the degree of diabetic retinopathy was significantly different. There were no significant differences in age, frequency of self-monitoring of blood glucose, or Hypoglycemia Fear Survey (HFS-B for behavior, HFS-W for worry) score at baseline between the adherent and nonadherent groups. The Problem Areas in Diabetes (PAID) score at baseline was significantly higher and the total CSII-QOL score at baseline was significantly lower in the adherent group. The usage of dual-wave bolus was significantly increased in the adherent group (34.6%-61.5%, P = .016), but not in the nonadherent group (33.3%-33.3%, P > .999). The HbA1c level showed a significant improvement in the adherent group (7.8%-7.3%, P < .001), but not in the nonadherent group (7.5%-7.2%, P = .102). CONCLUSIONS: Higher adherence to CGM sensors may be associated with a heavier emotional burden of diabetes and a worse QOL in relation to CSII at baseline.

Protocol for a Randomized, Crossover Trial to Decrease Time in Hypoglycemia by Combined Intervention of the Usage of Intermittent-Scanning Continuous Glucose Monitoring Device and the Structured Education Regarding its Usage: Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study (ISCHIA Study).

OBJECTIVE: Intermittent-scanning continuous glucose monitoring (isCGM) is widely used in type 1 diabetes (T1D) patients; however, the education required to prevent hypoglycemia by using isCGM is not established. This study examines the combined effect of isCGM device usage and the education to reduce the time in hypoglycemia in comparison to conventional self-monitoring of blood glucose (SMBG). METHODS: The Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study (ISCHIA Study), a randomized, crossover trial, enrolls 104 T1D patients (age, 20-74 years) with T1D. Participants are randomized to use isCGM combined with structured education (Intervention period) or SMBG (Control period) for 84 days, followed by the other for a further 84 days. During the Intervention period, participants have access to the sensor glucose levels and trend arrow of the device. During the Control period, participants conduct SMBG at least three times a day, and retrospective CGM is used to record the blinded sensor glucose levels. The primary endpoint is the decrease of time in hypoglycemia ( < 70 mg/dL) per day (hour/day) during the Intervention period compared with the Control period. The secondary endpoints include other indices of glycemic control, glycoalbumin, accuracy of isCGM, diabetes-related quality of life (QOL), adherence, and cost-effectiveness. The study protocol has received Certified Review Board (CRB) approval from National Hospital Organization Osaka National Hospital (N2018002, Feb 14, 2019). This study is carried out in accordance with the Declaration of Helsinki and the Clinical Trials Act. The findings will be published in peer-reviewed journals. CONCLUSION: The ISCHIA study will contribute to the standardization of patient education regarding the prevention of hypoglycemia by using isCGM.

Association Between Psychological Distress and Stress-Related Symptoms and Increased Risk of Type 2 Diabetes in Male Individuals: An Observational Study.

BACKGROUND: This study evaluated the association between psychological distress and development of type 2 diabetes (T2D) among male individuals in the workplace. METHODS: This observational cohort study enrolled 6,326 male participants aged 18 - 65 years (mean age 47.4 ± 9.5 years, body mass index 23.4 ± 3.4 kg/m2, hemoglobin A1c 5.5±0.3%), who received annual health checkups from April 2016 to March 2017. Those who had a hemoglobin A1c level ≥ 6.5%, previous history of diabetes, or used diabetes medication were excluded from the analysis. Psychological distress was measured using the Brief Job Stress Questionnaire. Multivariate Cox proportional hazard regression models were used to estimate the development of T2D in relation to psychological distress and stress-related symptoms. The calculated hazard ratio (aHR) was adjusted for age, body mass index, and hemoglobin A1c level. RESULTS: During a mean follow-up period of 1.9 years, the incidence rate of new-onset T2D was 2.0%. Baseline psychological parameters did not differ between participants with or without new-onset T2D. Depression was associated with an increased risk of T2D (aHR = 1.54, 95% confidence interval (CI): 1.07 - 2.22), whereas vigor, irritation, fatigue, and anxiety were not. Moreover, inability to handle work (aHR = 2.18, 95% CI: 1.14 - 4.19), sadness (aHR = 1.93, 95% CI: 1.14 - 3.26), headache (aHR = 1.98, 95% CI: 1.18 - 3.34), shoulder stiffness (aHR = 1.56, 95% CI: 1.10 - 2.23), and constipation/diarrhea (aHR = 1.71, 95% CI: 1.04 - 2.80) were associated with T2D incidence. CONCLUSIONS: Depression and stress-related symptoms were associated with an increased risk of T2D. Industrial physicians and health care providers should evaluate these factors during health checkups to lower the T2D incidence in this population.

Self-weighing frequency and the incidence of type 2 diabetes: post hoc analysis of a cluster-randomized controlled trial.

OBJECTIVES: Frequent self-weighing is associated with weight loss and maintenance, but the relationship between frequent self-weighing and the incidence of type 2 diabetes (T2D) remains unclear. The study aim was to examine the association between self-weighing frequency and the incidence of T2D in people with impaired fasting glucose (IFG). RESULTS: We tested the hypothesis that self-weighing frequency and the incidence of T2D are associated in 2607 people with IFG (1240 in the intervention arm; 1367 in the self-directed control arm). Both arms received a weighing scale with storage function. Healthcare providers offered a one-year goal-focused lifestyle intervention via phone. Participants were divided into 4 categories based on self-weighing frequency (No data sent [reference group], low: < 2 times/week, middle: 3-4 times/week, and high: 5-7 times/week). The adjusted hazard ratio (AHR) and 95% confidence interval (CI) were calculated. In the intervention arm, middle- and high-frequency self-weighing were associated with a decreased incidence of T2D relative to the reference group (AHR = 0.56, 95% CI [0.32, 0.98] and AHR = 0.43, 95% CI [0.25, 0.74], respectively). In the control arm, high-frequency self-weighing was also associated with a decreased incidence of T2D relative to the reference group (AHR = 0.54, 95% CI [0.35, 0.83]). Trial registration This trial has been registered with the University Hospital Medical Information Network (UMIN000000662).

Effects of obesity, metabolic syndrome, and non-alcoholic or alcoholic elevated liver enzymes on incidence of diabetes following lifestyle intervention: A subanalysis of the J-DOIT1.

OBJECTIVES: Using annual health check-up data, the aim of this study was to identify target populations for lifestyle interventions to effectively prevent diabetes in a real-world setting. METHODS: The Japan Diabetes Outcome Intervention Trial-1, a prospective, cluster-randomized controlled trial, was launched to test if year-long telephone-delivered lifestyle support by health professionals can prevent the development of type 2 diabetes (T2D) in people with impaired fasting glucose (IFG) identified at health check-ups. A total of 2607 participants aged 20-65 years with IFG were randomized to an intervention arm (n = 1240) or a control arm (n = 1367). We performed subgroup analysis to examine the effects of the intervention on the incidence of T2D in participants with body mass index (BMI) ≥25, metabolic syndrome (MetS), and non-alcoholic or alcoholic elevated liver enzymes at the baseline. Cox regression analysis adjusted for sex was used to calculate the hazard ratios (HRs). RESULTS: In addition to IFG, the presence of BMI ≥25, MetS, and elevated liver enzymes increased the incidence of diabetes by two- or three-fold. During a median follow-up period of 4.9 years, only the non-alcoholic elevated liver enzyme group showed a low incidence rate owing to lifestyle interventions (adjusted HR: 0.42, 95% confidence interval: 0.18-0.98). CONCLUSION: The results suggest that people who have IFG and non-alcoholic elevated liver enzymes are a good target population for lifestyle interventions to effectively reduce the incidence of diabetes in a real-world setting.

Development and Validation of the Continuous Subcutaneous Insulin Infusion-Related Quality-of-Life (CSII-QOL) Scale.

Background: Continuous subcutaneous insulin infusion (CSII) is associated with improved glycemic control, a reduced incidence of hypoglycemia, and improved quality of life (QOL). To date, however, there has been no QOL scale specific to CSII. The objective of this study was to develop and validate a scale to measure CSII-QOL for people with type 1 diabetes (T1D). Methods: A total of 50 people with T1D aged ≥15 years who used CSII (28% males; age, 47.6 ± 17.0 years; duration of diabetes, 14.7 ± 9.7 years; duration of CSII use, 6.1 ± 3.3 years; HbA1c, 7.4% ± 0.8%) took part in the CSII-QOL study. Twenty-eight potential CSII-QOL items were developed in a combined approach consisting of semistructured patient interviews, expert input, and a literature search. The resulting CSII-QOL was tested for factor analysis, validity, reliability, and influencing factors. Results: The final 25-item questionnaire had a 3-domain structure ("convenience," "social restriction," and "psychological problems"), high internal consistency (Cronbach's alpha = 0.870), and substantial test-retest reliability (intraclass correlation coefficient = 0.65). The CSII-QOL score was correlated negatively with the Problem Areas in Diabetes score. Conclusion: The CSII-QOL is the first CSII-related QOL scale for people with T1D. This short, validated, and reliable instrument might potentially be useful in future clinical studies and routine clinical patient care. Further validation is required to confirm these issues because of the small and potentially biased sample (UMIN-CTR: UMIN000031595).

An optimal condition for the evaluation of human brown adipose tissue by infrared thermography.

Brown adipose tissue (BAT) is responsible for non-shivering thermogenesis and is an attractive therapeutic target for combating obesity and related diseases. Human BAT activity has been evaluated by 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18FDG-PET/CT) under acute cold exposure, but the method has some serious limitations, including radiation exposure. Infrared thermography (IRT) may be a simple and less-invasive alternative to evaluate BAT activity. In the present study, to establish an optimal condition for IRT, using a thermal imaging camera, skin temperature was measured in the supraclavicular region close to BAT depots (Tscv) and the control chest region (Tc) in 24 young healthy volunteers. Their BAT activity was assessed as the maximal standardized uptake value (SUVmax) by 18FDG-PET/CT. Under a warm condition at 24-27°C, no significant correlation was found between the IRT parameters (Tscv, Tc,, and the difference between Tscv and Tc,, Δtemp) and SUVmax, but 30-120 min after cold exposure at 19°C, Tscv and Δtemp were significantly correlated with SUVmax (r = 0.40-0.48 and r = 0.68-0.76). Δtemp after cold exposure was not affected by mean body temperature, body fatness, and skin blood flow. A lower correlation (r = 0.43) of Δtemp with SUVmax was also obtained when the participant's hands were immersed in water at 18°C for 5 min. Receiver operating characteristic analysis revealed that Δtemp after 30-60 min cold exposure can be used as an index for BAT evaluation with 74% sensitivity, 92% specificity, and 79% diagnostic accuracy. Thus, IRT may be useful as a simple and less-invasive method for evaluating BAT, particularly for large-scale screening and longitudinal repeat studies.

Prevention of Metabolic Syndrome by Telephone-Delivered Lifestyle Intervention in a Real-World Setting: Sub-Analysis of a Cluster-Randomized Trial.

Background: Evidence of the long-term benefits of telephone-delivered lifestyle interventions is limited. This study investigated the ability of telephone-delivered lifestyle intervention to reduce the incidence of metabolic syndrome (MetS) in subjects diagnosed with impaired fasting glucose (IFG) during health checkups. Methods: Our subjects were participants in the Japan Diabetes Outcome Intervention Trial-1 (J-DOIT1), a prospective, cluster-randomized controlled trial designed to investigate whether goal-focused lifestyle coaching over the telephone can effectively reduce the incidence of type 2 diabetes development in high-risk individuals in a primary health care setting. We extracted 753 and 844 J-DOIT1 participants from the intervention and controls arms, respectively, who had IFG but did not meet the MetS criteria at baseline. The intervention arm received goal-focused lifestyle support delivered by health care providers via telephone over a 1-year period. The endpoint was the development of incident MetS, defined based on the Adult Treatment Panel III criteria modified for Japan. Results: During the median follow-up period of 4.9 years, 8.0% of the intervention arm and 12.0% of the control arm developed MetS. Overall, the hazard ratio (HR) for the development of MetS was 0.75 [95% confidence interval (CI), 0.52-1.09; P = 0.14] in the intervention arm. However, the HR in overweight or obese [body mass index (BMI) ≥23 kg/m2] individuals was significantly reduced to 0.63 (95% CI, 0.41-0.95; P = 0.029), but not in lean (BMI <23 kg/m2) individuals. Conclusion: Telephone-delivered lifestyle intervention effectively reduced the incidence of MetS in overweight and obese subjects in a real-world setting. Clinical trial registration number: UMIN000000662 (registered March 30, 2007; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000000798).

The Effect of High-concentration Insulin Glarigine on the Quality of Life of Patients with Type 2 Diabetes Mellitus: A Pre-post Study (HIGH-QOL STUDY).

Objective We compared the pain accompanying the injection of high-concentration (300 units/mL) insulin glargine (U300G) with that accompanying the injection of conventional (100 units/mL) insulin glargine (U100G). Methods U100G was switched to U300G at basically the same dosage. Visual analog scales were used to assess the quality of life (QOL). The primary outcome was the change in the pain accompanying injections in those using ≥30 units of U100G compared with those using <30 units at baseline. Standardized mean differences (Cohen's d) were used to measure the effect size. Patients Adult patients with type 2 diabetes mellitus using U100G. Results One hundred and eight patients were recruited. The numbers of patients who used U100G at ≥30 units, 20 to <30 units, 10 to <20 units, and <10 units were 13, 14, 34, and 47, respectively. The improvement in the pain score was not significant for ≥30 units compared with <30 units (-50.3±24.0 vs. -40.4±28.5, p=0.25, d=0.38), but a significant difference was observed for ≥20 units compared with <20 units (-50.8±22.7 vs. -38.4±29.1, p=0.03, d=0.48), as well as for ≥10 units compared with <10 units (-48.1±25.0 vs. -33.0±29.7, p<0.01, d=0.56). When all patients were analyzed together, significant improvements in the pain score (-41.5±28.0, p<0.01), ease of use score (-37.5±32.2, p<0.01), force needed to inject score (-46.5±28.6, p<0.01), and preference for U300G compared with U100G score (-45.8±33.1, p<0.01) were observed. Conclusion There is possibility that switching from U100G to U300G might be associated with better QOL for patients who require insulin glargine injections. To prove this hypothesis, a randomized controlled trial (preferably double-blinded) will be required in the future.