Effects of Elobixibat in Patients with Diabetes and Concomitant Chronic Constipation: an 8-week, Prospective, Single-center, Single-arm Study.

AIMS: To evaluate the efficacy and safety of elobixibat in patients with diabetes and concomitant chronic constipation. METHODS: This was a single-center, single-arm study. Thirty-three patients with diabetes and chronic constipation, as defined by the Rome IV criteria, were treated with elobixibat (10 mg/day) for 8 weeks. Patients recorded stool properties, including spontaneous bowel movements (SBMs) and stool consistency, according to the Bristol Stool Form Scale (BSFS). Quality of life for constipation was evaluated with the Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC-QOL). RESULTS: Of the 33 eligible patients, 30 completed the study. Elobixibat significantly increased the median (interquartile range) frequency of SBMs per week, from 5.0 (3.0-7.0) at baseline to 6.0 (4.0-7.0] at week 8 (p = 0.030). After 8 weeks, the BSFS score approached 4; the score for normal stool consistency and the JPAC-QOL score significantly improved from 1.05 ± 0.40 at baseline to 0.94 ± 0.53 (p = 0.048); and glycated albumin and serum lipid profiles significantly improved. Stratified analysis revealed that SBMs increased especially in patients with low SBM frequency, in particular in women, older adults, patients without overweight, patients with a long duration of constipation, and patients with diabetic neuropathy. No serious adverse events occurred. CONCLUSIONS: Among patients with diabetes who met the Rome IV criteria for constipation, elobixibat was effective, especially in those with few SBMs at baseline. Improvements in lipid profiles could be an advantage of elobixibat compared with other laxatives. CLINICAL TRIAL REGISTRY: Japan Registry of Clinical Trials registration number: jRCTs031190092.

Effects of resistance training using elastic bands on muscle strength with or without a leucine supplement for 48 weeks in elderly patients with type 2 diabetes.

Type 2 diabetes is associated with sarcopenia. Resistance training and appropriate nutritional therapy are reported to be effective for muscle strength and mass. This study aimed to evaluate the effect of resistance training using elastic bands at home combined with a leucine-rich amino acid supplement on muscle strength, physical function, and muscle mass in elderly type 2 diabetes. We conducted a 48-week prospective single-center randomized controlled trial in 60 patients who were randomly allocated to one of three groups: control (C), resistance exercise (R), and resistance exercise plus supplement (RL). R and RL groups performed daily bodyweight resistance training with elastic bands exercises at home, and the RL group also took 6 g of a leucine-rich amino acid supplement daily. Knee extension strength (muscle strength), grip strength, usual gait speed (physical function), muscle mass, and cognitive function were assessed at 0 and 48 weeks. Although the change in knee extension strength from baseline was significantly increased by 6.4 Nm (95% CI 1.0, 11.7) in the RL group (p = 0.036), no significant difference was observed among the three groups (p = 0.090). Physical function, muscle mass, and cognitive function also had no changes during the study period among the three groups. No additive effect of a leucine-rich amino acid supplement on muscle strength or mass was observed. Although a post hoc analysis comparing with or without resistance training (C group vs. R + RL group) found that knee extension strength was significantly increased (p = 0.028), and cognitive decline was less (p = 0.046) than in the C group.

A retrospective cohort study for the treatment of Asian diabetic ketoacidosis: optimizing initial doses of insulin.

AIM: An insulin dose of 0.1 U/kg/h recommended by Western guidelines occasionally induces a precipitous decreasing blood glucose in Asian diabetic ketoacidosis (DKA). It is known that clinical factors, such as insulin sensitivity, differ between Asians and Americans/Europeans. We investigated how treatment options affect the time to DKA resolution to determine the optimal treatment for Asian DKA patients. METHODS: This was a retrospective cohort study from a single institution in Japan. A total of 34 adult DKA patients were observed. Baseline characteristics and treatment-related parameters were compared between patients whose DKA was resolved within 18 h and those in which it was not. RESULTS: Significant differences were observed in the initial insulin dose (mean [standard deviation]: 0.053 [0.021] versus 0.031 [0.014] U/kg/h; P = 0.003) and the baseline ß-hydroxybutyrate (7.2 [3.2] versus 9.9 [2.6] mmol/L; P = 0.024) and HCO 3 - levels (11.2 [4.1] versus 7.7 [3.1] mmol/L; P = 0.014). Multivariable logistic regression analysis revealed that the initial insulin dose was significantly associated with early resolution of DKA and was independent of basal conditions. Receiver operating characteristic curve analysis indicated that the optimal cut-off point for the initial insulin dose was 0.051 U/kg/h. With an initial insulin dose of 0.051 U/kg/h or higher, early resolution of DKA was obtained in 92.9% of patients. CONCLUSION: An initial insulin dose of more than 0.05 U/kg/h provides an early resolution of DKA in Asian patients. Lower insulin doses significantly delay resolution. These results provide practical information for acute phase treatment of Asian DKA.