Comparison of insulin degludec (IDeg)/insulin Aspart (IAsp) co-formulation therapy twice-daily with free combination of GLP-1 receptor agonist liraglutide plus insulin degludec in Tochigi: IDEAL Trial.

AIM: We compared the efficacy and safety of insulin degludec/insulin aspart co-formulation (IDegAsp) twice-daily to a free combination of basal insulin degludec and GLP-1 receptor agonist liraglutide (IDeg + Lira) once-daily for patients with inadequately controlled type 2 diabetes on insulin therapy and oral antidiabetic drugs. SUBJECTS AND METHODS: Eligible patients were randomly allocated at a 1:1 ratio to receive either the once-daily dual injection of IDeg + Lira (n = 24) or twice-daily single injection of IDegAsp (n = 28). The primary endpoints were as follows: HbA1c changes over 52 weeks of treatment and the percentage of participants achieving HbA1c < 7.0% at week 52. RESULTS: After 52 weeks, HbA1c decreased by 0.3% in the IDegAsp group and by 0.7% in the IDeg + Lira group. The HbA1c reduction was greater in the IDeg + Lira group than in the IDegAsp group. 19% of patients on IDegAsp versus 40% on IDeg + Lira achieved HbA1c < 7.0%. Pre-breakfast and pre-dinner blood glucose at 52 weeks were significantly lower in the IDeg + Lira group than in the IDegAsp group. The reduction in body mass index (BMI) was greater in the IDeg + Lira group than in the IDegAsp group throughout the study period. The confirmed hypoglycaemia rates were 1.32 and 0.69 per patient/year of exposure to IDegAsp and IDeg + Lira, respectively. CONCLUSIONS: In patients with inadequately controlled type 2 diabetes on insulin therapy and oral antidiabetic drugs, treatment with the once-daily dual injection of IDeg + Lira compared with the twice-daily single injection of IDegAsp showed no significant difference in glycaemic control but statistically superior weight loss.

Effect of insulin degludec versus insulin glargine on glycemic control and daily fasting blood glucose variability in insulin-naïve Japanese patients with type 2 diabetes: I'D GOT trial.

AIMS: Insulin degludec (IDeg) is an ultra-long-acting insulin that has a smooth time/action profile over more than 42h. The present study compared the effects of IDeg and insulin glargine (IGlar) on HbA1c reduction and on within-subject day-to-day variability of fasting blood glucose (FBG) in insulin-naïve patients with type 2 diabetes. SUBJECTS AND METHODS: Eligible patients were randomly allocated at a 3:1 ratio to receive once-daily IDeg (n=31) or IGlar (n=12). Both basal insulins were administered before breakfast and titrated to achieve a target FBG <110mg/dl. The primary endpoints were the change in HbA1c from baseline to 24weeks of treatment, as well as the standard deviation (SD) and coefficient of variation (CV) of FBG from 8 to 12weeks and from 20 to 24weeks. Secondary endpoints included the QOL evaluated by the Diabetes Therapy-Related QOL questionnaire. RESULTS: After 24weeks, HbA1c was decreased by 1.6% in the IDeg group and 1.7% in the IGlar at the same insulin dosage. At 24weeks, FBG was significantly lower in the IDeg group than in the IGlar group and the CV of FBG was significantly smaller in the IDeg group. The frequency of total and severe hypoglycemic episodes did not differ between the groups. In the IDeg group, QOL showed significant improvement regarding anxiety and dissatisfaction with treatment. CONCLUSIONS: Treatment with IDeg or IGlar achieved similar improvement in glycemic control in insulin-naïve patients with type 2 diabetes. The day-to-day variation of FBG was smaller in patients receiving IDeg.

Association between numbers of decayed teeth and HbA1c in Japanese patients with type 2 diabetes mellitus.

BACKGROUND: Dental caries (DC) are more prevalent in individuals with diabetes than in healthy individuals. However, the association between glycaemic control and DC has not been well characterized in patients with type 2 diabetes mellitus (T2DM). We therefore assessed the association between glycated haemoglobin (HbA1c) serum concentrations and the prevalence of DC in patients with T2DM. METHODS: Retrospective analyses of data pertaining to 108 Japanese patients with T2DM hospitalized because of poor or worsened glycaemic control were included. We divided the patients based on HbA1c into two groups: HbA1c level ≥75 mmol/mol (9.0%) as poorly controlled T2DM, and HbA1c level <75 mmol/mol (9.0%) as a control group. We compared the association of lifestyle factors, dental caries, and periodontal health between patients with poorly controlled T2DM and controls. Stepwise multiple regression analyses were performed to evaluate the association between HbA1c, the absolute number of decayed teeth (DT), the sum of decayed, missing, and filled teeth, and the Met Need Index (MNI). RESULTS: DT was higher and MNI was lower in patients with poorly controlled T2DM as compared to that in controls (P = 0.006 and P = 0.004, respectively). Multiple regression analyses revealed a significant association between HbA1c levels and DT (adjusted ß = 0.039, 95% confidence interval [CI], 0.005 to 0.072, P = 0.025) and the MNI (adjusted ß = -0.216, 95% CI -0.374 to -0.058, P = 0.008). CONCLUSIONS: DT and MNI were associated with HbA1c in T2DM patients.

Altered serum level of matrix metalloproteinase-9 and its association with decision-making in eating disorders.

AIM: The aims of this study were to determine whether the serum levels of precursor brain-derived neurotrophic factor (proBDNF), mature BDNF (mBDNF), and matrix metalloproteinase-9 (MMP-9) are altered in patients with eating disorders (ED), including anorexia nervosa (AN) and bulimia nervosa (BN), and to explore whether those levels are associated with decision-making abilities. METHODS: Nineteen women with AN, 28 women with BN, and 22 age-matched healthy control women (HC) were enrolled in the current study. All participants had their decision-making abilities assessed using the Iowa Gambling Task (IGT). Their eating-related pathophysiology and depressive/anxiety symptoms were also evaluated. RESULTS: The MMP-9 level in AN was significantly lower than that in either BN or HC, but the serum levels of proBDNF and mBDNF did not differ among the three groups. Investigation of the serum levels of proBDNF and MMP-9 in patients with ED and controls revealed a significant correlation between them. In the BN, there were positive correlations between mBDNF level and IGT performance and also between MMP-9 level and IGT performance, but these correlations did not occur in AN. The MMP-9 level was positively associated with the Symptom Scale, one of the subscales of the Bulimic Investigatory Test, Edinburgh, only in AN. CONCLUSION: These results suggest that the serum level of MMP-9 plays a role in the pathophysiology of AN, and both the serum levels of mBDNF and MMP-9 may be associated with decision-making abilities in patients with BN.

Richter's Type of Incarcerated Obturator Hernia that Presented with a Deep Femoral Abscess: An Autopsy Case Report.

BACKGROUND Richter's obturator hernia is a rare abdominal hernia that is difficult to diagnose. The purpose of this case report is to show an unusual presentation of a fatal Richter's obturator hernia that was accompanied by a femoral abscess. CASE REPORT An 89-year-old woman complained of sudden left coxalgia and a gait disorder but no abdominal symptoms. She had no history of trauma or surgery in the inguinal area. Twenty-three days after her first complaint of coxalgia, the patient was admitted in a coma with necrotizing fasciitis in the left inguinal area. The patient died of asystole due to hyperkalemia. During surveillance for the cause of death, a Richter's type of incarcerated obturator hernia was identified at autopsy. The incarcerated small intestine had penetrated into the left obturator foramen to form an abscess that extended into the deep femoral region. CONCLUSIONS Obturator hernia accompanied by femoral abscess is extremely rare, but it should be suspected when a patient with no history of trauma or surgery has a femoral abscess, even in the absence of abdominal symptoms.

Comparison in decision-making between bulimia nervosa, anorexia nervosa, and healthy women: influence of mood status and pathological eating concerns.

BACKGROUND: Decision-making is reported to be impaired in anorexia nervosa (AN) and bulimia nervosa (BN), but the influence of mood status, pathophysiological eating, and weight concerns on the performance of decision-making ability between AN and BN is still unclear. The aims of this study were to investigate differential impairments in the decision-making process between AN, BN, and healthy controls (HC), and secondly, to explore the role of mood status, such as anxiety, depression, pathological eating, and weight concerns, in decision-making ability. METHODS: Patients suffering from AN (n = 22), BN (n = 36) and age-matched HC (n = 51) were assessed for their decision-making abilities using the Iowa Gambling Task (IGT). Self-reported questionnaires including the Eating Disorder Examination Questionnaire (EDE-Q), the Bulimia Investigatory Test, Edinburgh (BITE), the Eating Disorders Inventory, the Maudsley Obsessive-Compulsive Inventory measuring obsessive-compulsive traits, the Hospital Anxiety and Depression Scale, and the Toronto Alexithymia Scale were used to assess pathological eating concerns and attitude to feelings. RESULTS: Significant differences in IGT performance were observed between BN and HC. Significant negative correlation was found between IGT performance and the BITE symptom subscale in AN. In BN, there was a negative correlation between the EDE-Q weight concerns subscale and IGT performance. It was also found that increased anxiety, depression, and eating/weight concerns predicted poorer decision-making. CONCLUSION: Different patterns of association between pathological eating concerns/behaviors and performances in decision-making ability were found between AN, BN, and HC. Anxiety, depressive mood status, and eating/weight concerns were related to decision-making ability.

The effects of partial use of formula diet on weight reduction and metabolic variables in obese type 2 diabetic patients--multicenter trial.

AIMS: To clarify the usefulness of protein-sparing modified formula diet in obese type 2 diabetic patients, the effects of partial use of formula diet on weight reduction and changes in related metabolic variables, and the improving rates of risk factors per 1% body weight reduction, were compared with those of conventional subcaloric diet. SUBJECTS AND METHODS: Obese patients [BMI >25 kg/m²] with diabetic mellitus were randomly assigned to a low-caloric diet with partial use of formula diet group (FD, n = 119) and a conventional low-caloric diet group (CD, n = 110). Subjects in FD took one pack of formula diet (MicroDiet®, 240 kcal/pack) in place of one of three daily low-caloric meals for 24 weeks. Total daily calorie prescribed was same. RESULT: Weight reduction was greater in FD than in CD (week 24: -3.5 vs -1.4 kg; all p < 0.001). Systolic blood pressure decreased significantly only in FD. HbA1c reduction was greater in FD than in CD. HDL-cholesterol increased significantly more in FD than in CD (week 24: +2.8 vs. +0.6 mg/dl, p < 0.001). Among several improving rates (%) of risk factors/1% body weight reduction, those of HbA1c at weeks 16 and 24, triglyceride at week 8 and HDL-cholesterol at week 24, were significantly higher in FD than CD. Doses of sulfonylurea and thiazolidinedione were significantly decreased in FD than in CD. CONCLUSION: Partial use of formula diet was much more effective in reducing body weight, and also in improving coronary risk factors than conventional diet in part due to reduced body weight through decreased energy diet intake and due to dietary composition of the formula diet.

The relationship of percent body fat by bioelectrical impedance analysis with blood pressure, and glucose and lipid parameters.

The objective of this study was to clarify the clinical significance and usefulness of measuring percent body fat (PBF) when compared with body mass index (BMI) in the Japanese population. A total of 2,483 Japanese individuals (1,380 men and 1,103 women) who underwent a medical checkup from 1999-2002 were employed. PBF was determined using bioelectrical impedance analysis (BIA). Relationships of age, BMI and PBF with several metabolic parameters, including blood pressure, lipids and plasma glucose levels were assessed in both genders separately. In men, PBF was a stronger determinant of total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and triglycerides (TG) compared with age and BMI, whereas in women, age was the strongest determinant of TC and LDL-C. In both genders, BMI was the strongest determinant of serum HDL-C among age, PBF and BMI. Based on these data, we suggest that measuring PBF by BIA is superior to BMI for predicting TC, LDL-C and TG in Japanese men.

Gastric bypass in a Japanese man with Prader-Willi syndrome and morbid obesity.

BACKGROUND: In Prader-Willi syndrome (PrWS), marked obesity is the most serious and common complication, contributing significantly to morbidity and mortality. Because of the associated psychosocial difficulties, bariatric surgery appears to be the only effective treatment. CASE REPORT: A 30-year-old man with PrWS weighing 108 kg (BMI 50 kg/m2), underwent Roux-en-Y gastric bypass (RYGBP). 3 months before the RYGBP, he weighed 146 kg (BMI 68.5), partly because of heart failure. 18 months after RYGBP, he weighed 92.4 kg (BMI 43.3), with no postoperative complications. Moreover, he showed considerable increase in serum HDL-cholesterol levels with reciprocal reduction in LDL-cholesterol after the surgery. CONCLUSION: RYGBP resulted in satisfactory weight loss and improvement in serum lipid profile in a Japanese morbidly obese patient with PrWS.

Gender differences in the effect of type 2 diabetes on serum lipids, pre-heparin plasma lipoprotein lipase mass and other metabolic parameters in Japanese population.

DESIGN: Cross-sectional study of fasting serum lipid and lipoprotein levels, pre-heparin lipoprotein lipase (LPL) mass, several other metabolic parameters, and intra-abdominal fat areas in 26 Japanese poorly controlled type 2 diabetic men and 23 women when matched for age, body mass index (BMI), and HbA1c between genders. SUBJECTS: Study subjects were Japanese type 2 diabetic patients who were admitted to our hospital between Jun 2001 and Aug 2002 because of their poorly controlled diabetes. A total of 49 subjects [40-79 years of age, average age 61.5 +/- 8.7; mean BMI 23.2 +/- 3.7 kg/m2] with fasting plasma glucose (PG) and HbA1c levels being 251 +/- 76.5 mg/dl and 10.8 +/- 2.2%, respectively, were involved in this study. METHODS: Pre-heparin LPL mass was determined by enzyme linked immunosorbent assay. Remnant like particle cholesterol (RLP-C) level was measured using an immunoaffinity mixed gel containing anti-apolipoprotein (apo) A-I and anti-apo B monoclonal antibodies. Serum leptin level was determined by radioimmunoassay. Intra-abdominal fat area was determined by computerized tomography analysis at the umbilical level. RESULTS: The men group showed a higher serum triglycerides (TG) and RLP-C levels, and lower high density lipoprotein-cholesterol levels and pre-heparin plasma LPL mass than did women. Serum leptin level was higher in women than in men counterparts. The intra-abdominal subcutaneous fat areas were significantly larger in women than in men counterparts, whereas the visceral fat areas did not differ. CONCLUSION: In Japanese population, poorly controlled type 2 diabetic men had more unfavorable lipid profile than did women counterparts, which may be associated with decreased lipolysis of plasma TG-rich lipoproteins by LPL.

Marked reduction in serum high-density lipoprotein cholesterol concentrations in a woman with acute inflammation due to diabetic gangrene.

BACKGROUND: C-reactive protein (CRP) is a well-established, sensitive marker of systemic inflammation and the risk of cardiovascular disease. High-density lipoprotein (HDL) is an anti-atherogenic lipoprotein known to be regulated by genetic and acquired factors. METHODS: The patient was a 77-year-old Japanese woman, who was diagnosed with type 2 diabetes mellitus (DM), with a body height of 152 cm and a weight of 65 kg (body mass index 28.1 kg/m2). She suffered from diabetic foot gangrene in her right foot with high-grade fever when she visited our hospital. Her plasma glucose (PG) concentration and serum CRP were markedly elevated being 21.6 mmol/l and 370 mg/l, respectively, while her serum HDL-C concentrations were markedly low being 0.13 mmol/l. She was immediately admitted to our hospital and received intensive insulin treatment, along with intravenous-administration of antibiotics. Her general conditions were gradually improved and the high-grade fever disappeared, with concentrations of plasma PG and serum CRP being reduced, and concurrent reciprocal increase in her serum HDL-C concentrations. RESULTS: To determine the potential causative factors responsible for the drastic change in serum HDL-C concentrations, we investigated the relationship of serum HDL-C to serum CRP, serum total protein (TP) and PG. Serum CRP and PG showed inverse relationships with serum HDL-C, while serum TP concentrations showed a positive association with HDL-C. After multivariate analyses with CRP, TP and PG as independent variables and serum HDL-C as dependent variable, CRP maintained its independent association with serum HDL-C. CRP also showed inverse correlations with lipoprotein lipase (LPL) mass and cholesteryl ester transfer protein mass. CONCLUSIONS: In acute inflammation and poorly controlled diabetes, CRP is suggested to be inversely associated with serum HDL-C, independent of PG and TP.