Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study (PRIME-V study).

A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI) ≥ 22 kg/m2 . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (-12.06% vs. -3.65%, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors.

How Accurate Are First Visit Diagnoses Using Synchronous Video Visits with Physicians?

BACKGROUND: Telediagnosis (TD), which uses information and communications technology, has recently undergone rapid development. Since no studies have compared the diagnostic precision of TD to that of face-to-face diagnosis (FD), we examined and compared the diagnostic accuracy of these diagnostic approaches among general medicine outpatients. METHODS: Data of 97 patients (45 men and 52 women with a mean age of 52 years) who underwent initial examinations at a regional hospital were analyzed. Two fully trained general medicine physicians were selected from a group of three physicians to perform FD and TD. Levels of agreement (as κ coefficients) were determined between TD and FD diagnoses as well as between final diagnoses and TD and FD diagnoses. RESULTS: The κ coefficients were 0.75 for TD and FD and 0.81 for both, the final diagnoses and the TD and FD diagnoses, revealing a sufficiently high level of diagnostic agreement. CONCLUSIONS: TD can provide the same level of diagnostic accuracy as FD among general medicine outpatients for adults. The help of medical assistants and the utilization of physical examination devices might enable medical staff to provide TD care similar in quality to FD. TD could be a useful diagnostic tool when medical work force is limited (e.g., in remote areas, during natural disasters, and in at-home care).

A Case of Primary Intestinal Lymphangiectasia Successfully Controlled with a Denver Peritoneovenous Shunt for Refractory Ascites.

A 53-year-old man presented with abdominal symptoms and a fever for 6 months and ascites and lower body edema for 2 months before visiting our clinic. Heart failure, renal failure, inferior vena cava or portal vein obstruction, cirrhosis, and malignancy were suspected, but none were present. We also suspected protein-leakage gastroenteropathy based on the elevated alpha-1 antitrypsin clearance (224 mL/day). Based on the double-balloon endoscopy findings, we diagnosed the patient with primary intestinal lymphangiectasia. Since the patient's ascites were not satisfactorily controlled medically, a Denver peritoneovenous shunt was placed. As a result, the ascites volume was successfully controlled over an extended period.

Ludwig's angina and mask use.

Ludwig angina cases that could only be recognized by unmasking.

Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Subanalysis of a prospective, randomized, controlled study (PRIME-V study).

AIMS/INTRODUCTION: Recent randomized clinical trials have suggested that sodium-glucose cotransporter 2 inhibitors might reduce cardiovascular events and heart failure, and have renal protective effects. Despite these remarkable benefits, the effects of sodium-glucose cotransporter 2 inhibitors on bone and muscle are unclear. MATERIALS AND METHODS: A subanalysis of a randomized controlled study was carried out to evaluate the effects of the sodium-glucose cotransporter 2 inhibitor, ipragliflozin, versus metformin on bone and muscle in Japanese patients with type 2 diabetes mellitus (baseline body mass index ≥22 kg/m2 and hemoglobin A1c 7-10%) who were already receiving sitagliptin. These patients were randomly administered ipragliflozin 50 mg or metformin 1,000-1,500 mg daily. The effects of these medications on the bone formation marker, bone alkali phosphatase; the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra were evaluated. RESULTS: After 24 weeks of treatment, the changes in bone density of the fourth lumbar vertebra, handgrip strength and abdominal cross-sectional muscle area were not significantly different between the two groups. However, TRACP-5b levels increased in patients treated with ipragliflozin compared with patients treated with metformin (median 11.94 vs -10.30%, P < 0.0001), showing that ipragliflozin can promote bone resorption. CONCLUSIONS: There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin. However, ipragliflozin combination increased the levels of TRACP-5b. A long-term study is required to further understand the effects of this TRACP-5b increase caused by ipragliflozin.

Safety and Efficacy of Ranibizumab and Luseogliflozin Combination Therapy in Patients with Diabetic Macular Edema: Protocol for a Multicenter, Open-Label Randomized Controlled Trial.

INTRODUCTION: Diabetic macular edema (DME) threatens daily life activities such as reading and driving and reduces the patients' quality-of-life. Recently, anti-vascular endothelial growth factor (VEGF) agents have become a first-line therapy in DME. However, therapy with anti-VEGF agents has several problems: repeated invasive injections are required; medical costs are high; and a certain proportion of patients with DME are resistant to treatment with anti-VEGF agents. While sodium-glucose co-transporter 2 (SGLT2) inhibitors have been widely used for the treatment of type 2 diabetes mellitus (T2DM), the effects of a combination therapy with anti-VEGF agent and SGLT2 inhibitor on DME are not yet known. METHODS: This study enrolls subjects with T2DM and DME, randomizes them into either a study agent treatment group (treated with ranibizumab as anti-VEGF agent and luseogliflozin as SGLT2 inhibitor) or a control group (treated with ranibizumab and glimepiride), and observes the subjects for 52 weeks after initiation of treatment. Planned outcomes: The primary endpoint is intergroup difference in the number of intravitreal anti-VEGF injections to the study eye from baseline to week 48. Secondary and exploratory endpoints include safety and ophthalmologic and internal medical clinical parameters. REGISTRATION: This study is registered at the University Hospital Medical Information Network Clinical Trial Registry (UMIN000033961) and Japan Registry of Clinical Trials (jRCTs031180210).

Anxiety and depression in general practice outpatients: the long-term change process.

BACKGROUND AND OBJECTIVES: Patients who come for a consultation at a general practice clinic as outpatients often suffer from background anxiety and depression. The psychological state of such patients can alleviate naturally; however, there are cases when these symptoms persist. This study investigated the realities and factors behind anxiety/depression becoming prolonged. METHODS: Participants were 678 adult patients, who came to Department of General Medicine at Chiba University Hospital within a 1-year period starting from April 2012 and who completed the Hospital Anxiety and Depression Scale (HADS) during their initial consultation. Participants whose Anxiety or Depression scores in the HADS, or both, were 8 points or higher were defined as being within the anxiety/depression group, with all other participants making up the control group. A telephone interview was also conducted with participants. Furthermore, age, sex, the period from the onset of symptoms to the initial consultation at our department, the period from the initial department consultation to the telephone survey, and the existence of mental illness at the final department diagnosis were investigated. RESULTS: A total of 121 patients (17.8% response rate) agreed to the phone survey. The HADS score during the phone survey showed that the anxiety/depression group had a significantly higher score than the control group. The HADS scores obtained between the initial consultation and telephone survey showed a positive correlation. Logistic regression analysis extracted "age" and the "continuation of the symptoms during the initial consultation" as factors that prolonged anxiety/depression. CONCLUSION: Anxiety and depression in general practice outpatients have the possibility of becoming prolonged for an extended period of time. Being aged 65 years or over and showing a continuation of symptoms past the initial consultation are the strongest factors associated with these prolonged conditions. When patients with anxiety and depression exhibit these risk factors, they should be further evaluated for treatment.

The absence of evidence for major effects of the frequent SNP +299G>A in the resistin gene on susceptibility to insulin resistance syndrome associated with Japanese type 2 diabetes.

Resistin, specifically secreted from adipocytes, antagonizes insulin and represents a promising candidate gene for type 2 diabetes. We reported that a frequent single nucleotide polymorphism (SNP) +299G>A in this gene is not associated with type 2 diabetes. To determine whether this SNP affects insulin resistance syndrome associated with type 2 diabetes, we examined its effects on susceptibility to obesity, hyperlipidemia and hypertension in type 2 diabetic subjects and on susceptibility to type 2 diabetes by interaction with other frequent genes involved in lipid metabolism, namely, beta3-adrenergic receptor (b3AR) Trp64Arg, phosphodiesterase 3B (PDE3B) c.1389G>A or lysosomal acid lipase (LAL) Thr-6Pro. The 99 type 2 diabetic and 99 control subjects were typed by PCR direct sequencing or PCR-RFLP. No differences in frequencies of obesity, hyperlipidemia and hypertension were found between the type 2 diabetic subjects with G/G and those with G/A or A/A genotypes of the resistin SNP. When the combination of the resistin SNP with each of b3AR, PDE3B and LAL SNPs was assessed, no association with type 2 diabetes was evident. Therefore, the frequent SNP +299G>A in the resistin gene is unlikely to have major effects on susceptibility to insulin resistance syndrome associated with type 2 diabetes in Japanese subjects.

A low-grade increase of serum pancreatic exocrine enzyme levels by dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes.

A potential adverse effect of dipeptidyl peptidase-4 inhibitors (DPP-4i) on the pancreas remains controversial. We evaluated the DPP-4i effects on pancreatic amylase and lipase activity in patients with type 2 diabetes. These enzymes were slightly but significantly increased, suggesting DPP-4i cause a low-grade inflammatory change in the exocrine pancreas.

[X-ray phase imaging using a X-ray tube with a small focal spot -improvement of image quality in mammography-].

Phase contrast X-ray imaging has been studied intensively using X-rays from synchrotron radiation and micro-focus X-ray tubes. However, these studies have revealed the difficulty of this technique's application to practical medical imaging. We have created a phase contrast imaging technique using a molybdenum X-ray tube with a small focal spot size for mammography. We identified the radiographic conditions in phase contrast magnification mammography with a screen-film system, where edge effect due to phase contrast overcomes geometrical unsharpness caused by the 0.1mm-focal spot of a molybdenum X-ray tube. The edge enhancement due to phase imaging was observed in an image of a plastic tube, and then geometrical configuration of the X-ray tube, the object and the screen-film system was determined for phase imaging of mammography. In order to investigate a potential for medical application of this method, we conducted evaluation of the images of ACR 156 mammography phantom. We obtained higher scores for phase imaging using high speed screen-film systems without any increase of X-ray dose than the score for contact imaging using a standard speed screen-film system.