Aggressive surgery for incisional hernia with necrotizing soft tissue infection highlighting unique abdominal findings.

Background: Surgery for incisional hernias with obesity can be more challenging because obesity is associated with perioperative complications. Necrotizing soft tissue infection (NSTI) is a life-threatening condition that requires aggressive surgical management. Few incisional hernias with NSTI have been reported, and the optimal strategy is undetermined. Case Presentation: A 66-year-old obese woman had been diagnosed with incisional hernia 4 years previously but was not treated. She presented with abdominal pain that had worsened 2 weeks previously. Emergency radical surgery was carried out for an incisional hernia with NSTI. The abdominal fascia was sutured directly without mesh. Negative pressure wound therapy was performed after surgery. The postoperative course was uneventful, without recurrence. Conclusions: Aggressive surgery is a valid strategy for life-threatening incisional hernias with NSTI. Strategies should be developed based on physiological and anatomical findings.

Radical surgery for intractable thoracic empyema complicating traumatic pneumothorax and rib fractures.

BACKGROUND: Few cases of traumatic pneumothorax complicated by thoracic empyema have been reported. The indication of antibiotic prophylaxis administration for traumatic pneumothorax during tube thoracostomy remains controversial, and thoracic injury complicated by empyema can be life-threatening and intractable. CASE PRESENTATION: A 42-year-old male patient was injured during a collision with a passenger car while driving a motorcycle. The patient (body mass index, 37 kg/m2) was diagnosed with right first-to-sixth-rib fractures without a flail segment, right clavicle fracture, and slight hemopneumothorax. Tube thoracostomy was performed for traumatic pneumothorax on day 3 without antibiotic prophylaxis. The patient demonstrated a progressive displaced rib fracture complicated by empyema on day 11. Radical surgery was performed for the empyema with rib fixation on day 15. The postoperative course was uneventful, and the patient was discharged from the hospital on day 31. CONCLUSIONS: A traumatic pneumothorax can be complicated by empyema. Thoracic injuries complicated by empyema can be life-threatening and intractable. Antibiotic prophylaxis for traumatic pneumothorax with tube thoracotomy should therefore be considered in select cases. The strategy for thoracic injury requires the assumption of an occult thoracic infection and chest wall instability.

Dietary protein intake and all-cause mortality: results from The Kawasaki Aging and Wellbeing Project.

BACKGROUND: Increased protein intake has been recommended to prevent sarcopenia/frailty, reports on the quantity and quality of protein intake needed and the associated prognosis, particularly in the aging population of Asia, are limited. In this study, we aimed to investigate the relationship between protein intake and mortality in Japanese individuals, aged 85 years and older. METHODS: The data were obtained from The Kawasaki Aging and Wellbeing Project, which is a prospective cohort study of older adults aged between 85 and 89 years with no physical disability at baseline. Of the 1,026 adults in the cohort, 833 were included in the analysis, after excluding those who had not completed a brief, self-administered diet history questionnaire or those who scored less than 24 on the Mini-Mental State Examination. The participants were grouped into quartiles based on protein intake: Q1 (protein < 14.7, %Energy), Q2 (14.7 ≤ protein < 16.7, %Energy), Q3 (16.7 ≤ protein < 19.1, %Energy), and Q4 (≥ 19.1, %Energy). Multivariate Cox proportional hazards models were utilized to evaluate the association between protein intake and all-cause mortality. Kaplan-Meier survival curves were employed to investigate the relationship between protein intake and all-cause mortality. RESULTS: The mean protein intake of our study population was 17.0% of total energy. Animal protein intake, particularly fish intake, increased significantly along with total protein intake. The study had an average observation period of 1,218 days and recorded 89 deaths. After adjusting for age, sex, skeletal muscle mass index, cardiovascular disease, cancer, education, and serum albumin levels, a lower risk of all-cause mortality was observed in the highest protein intake (Q4) group than in the lowest protein intake (Q1) group (hazard ratio: 0.44, 95% confidence interval: 0.22-0.90, p-value: 0.020). CONCLUSION: Protein intake is associated with a reduced risk of all-cause mortality in older adults (aged ≥ 85 years) who engage in independent activities of daily living. This association may impact all-cause mortality independent of muscle mass.

First-onset type 1 diabetes in an elderly woman with multiple islet-associated autoantibodies, and a literature review.

An 80-year-old Japanese woman had shown no indication of diabetes but regularly saw a primary-care physician for health management. Six months before her referral to our hospital, her HbA1c was 6.0%. She was referred to us for diabetic ketosis because she was urine ketone body-positive with a blood glucose level of 397 mg/dL and HbA1c of 14.6%. She was diagnosed with type 1 diabetes mellitus (T1DM) with glutamic acid decarboxylase (GAD) antibodies >2,000 U/mL (by ELISA) and IA-2 antibodies >30 U/mL. Insulin injections were introduced, and she was discharged. Laboratory tests during her hospitalization were negative for thyroid antibodies (TgAb, TPOAb). Elderly individuals with first-onset T1DM who are positive for IA-2 antibody are rare, and multiple-positive cases of pancreatic islet-associated autoantibodies are particularly rare. IA-2 antibodies have an approx. 60% positive rate in acute-onset T1DM, but they are more likely to be positive in children and adolescents and are known to turn negative earlier than anti-GAD antibodies. Although a large amount of insulin is needed in general in such cases, our patient was successfully treated with a small amount of insulin. IA-2 antibody has been reported to be positive even in GAD antibody-negative individuals. In some cases, IA-2 antibody and other antibodies are positive even in elderly-onset diabetes, and this contributes to the diagnosis of T1DM.

Pediatric blunt abdominal trauma with horizontal duodenal injury in school baseball: A case report.

RATIONALE: Pediatric sports injuries, including those from baseball, most often are musculoskeletal injuries and rarely include blunt abdominal injuries. Duodenal injury is rare and often associated with other organ injuries. Because it has a relatively high mortality, early recognition and timely treatment are needed. Here, we report a case of successful treatment of a pediatric patient with duodenal injury incurred in the context of school baseball. PATIENT CONCERNS: A 13-year-old boy suffered blunt abdominal trauma and a right-hand injury caused by beating his abdomen strongly with his own right knuckle after he performed a diving catch during a baseball game. On the following day, the abdominal pain had worsened. DIAGNOSES: Computed tomography led to a suspicion of injury to the horizontal part of the duodenum. INTERVENTIONS: The duodenal injuries were repaired by simple closure. On the 10th post-operative day, an abscess formed in the retroperitoneal cavity because of an occult pancreatic injury. Ultrasound-guided percutaneous drainage of the cavity was performed. OUTCOMES: The post-operative course of the abscess drainage was uneventful. The patient was discharged from our hospital on day 72 after admission and was in good health at the 9-month follow-up. LESSONS: Regardless of the type of injury, we must assess the life-threatening conditions that can be expected based on the mechanism of the injury. In duodenal injuries, it is critical to perform surgical procedures and post-operative management based on the assumption of injuries to other organs.

ApoA-I/A-II-HDL positively associates with apoB-lipoproteins as a potential atherogenic indicator.

BACKGROUND: We recently reported distinct nature of high-density lipoproteins (HDL) subgroup particles with apolipoprotein (apo) A-I but not apoA-II (LpAI) and HDL having both (LpAI:AII) based on the data from 314 Japanese. While plasma HDL level almost exclusively depends on concentration of LpAI having 3 to 4 apoA-I molecules, LpAI:AII appeared with almost constant concentration regardless of plasma HDL levels having stable structure with two apoA-I and one disulfide-dimeric apoA-II molecules (Sci. Rep. 6; 31,532, 2016). The aim of this study is further characterization of LpAI:AII with respect to its role in atherogenesis. METHODS: Association of LpAI, LpAI:AII and other HDL parameters with apoB-lipoprotein parameters was analyzed among the cohort data above. RESULTS: ApoA-I in LpAI negatively correlated with the apoB-lipoprotein parameters such as apoB, triglyceride, nonHDL-cholesterol, and nonHDL-cholesterol + triglyceride, which are apparently reflected in the relations of the total HDL parameters to apoB-lipoproteins. In contrast, apoA-I in LpAI:AII and apoA-II positively correlated to the apoB-lipoprotein parameters even within their small range of variation. These relationships are independent of sex, but may slightly be influenced by the activity-related CETP mutations. CONCLUSIONS: The study suggested that LpAI:AII is an atherogenic indicator rather than antiatherogenic. These sub-fractions of HDL are to be evaluated separately for estimating atherogenic risk of the patients.

Bioinformatic Analysis of Plasma Apolipoproteins A-I and A-II Revealed Unique Features of A-I/A-II HDL Particles in Human Plasma.

Plasma concentration of apoA-I, apoA-II and apoA-II-unassociated apoA-I was analyzed in 314 Japanese subjects (177 males and 137 females), including one (male) homozygote and 37 (20 males and 17 females) heterozygotes of genetic CETP deficiency. ApoA-I unassociated with apoA-II markedly and linearly increased with HDL-cholesterol, while apoA-II increased only very slightly and the ratio of apoA-II-associated apoA-I to apoA-II stayed constant at 2 in molar ratio throughout the increase of HDL-cholesterol, among the wild type and heterozygous CETP deficiency. Thus, overall HDL concentration almost exclusively depends on HDL with apoA-I without apoA-II (LpAI) while concentration of HDL containing apoA-I and apoA-II (LpAI:AII) is constant having a fixed molar ratio of 2 : 1 regardless of total HDL and apoA-I concentration. Distribution of apoA-I between LpAI and LpAI:AII is consistent with a model of statistical partitioning regardless of sex and CETP genotype. The analysis also indicated that LpA-I accommodates on average 4 apoA-I molecules and has a clearance rate indistinguishable from LpAI:AII. Independent evidence indicated LpAI:A-II has a diameter 20% smaller than LpAI, consistent with a model having two apoA-I and one apoA-II. The functional contribution of these particles is to be investigated.

Vascular Ehlers-Danlos syndrome without the characteristic facial features: a case report.

As a type of Ehlers-Danlos syndrome (EDS), vascular EDs (vEDS) is typified by a number of characteristic facial features (eg, large eyes, small chin, sunken cheeks, thin nose and lips, lobeless ears). However, vEDs does not typically display hypermobility of the large joints and skin hyperextensibility, which are features typical of the more common forms of EDS. Thus, colonic perforation or aneurysm rupture may be the first presentation of the disease. Because both complications are associated with a reduced life expectancy for individuals with this condition, an awareness of the clinical features of vEDS is important. Here, we describe the treatment of vEDS lacking the characteristic facial attributes in a 24-year-old healthy man who presented to the emergency room with abdominal pain. Enhanced computed tomography revealed diverticula and perforation in the sigmoid colon. The lesion of the sigmoid colon perforation was removed, and Hartmann procedure was performed. During the surgery, the control of bleeding was required because of vascular fragility. Subsequent molecular and genetic analysis was performed based on the suspected diagnosis of vEDS. These analyses revealed reduced type III collagen synthesis in cultured skin fibroblasts and identified a previously undocumented mutation in the gene for a1 type III collagen, confirming the diagnosis of vEDS. After eliciting a detailed medical profile, we learned his mother had a history of extensive bruising since childhood and idiopathic hematothorax. Both were prescribed oral celiprolol. One year after admission, the patient was free of recurrent perforation. This case illustrates an awareness of the clinical characteristics of vEDS and the family history is important because of the high mortality from this condition even in young people. Importantly, genetic assays could help in determining the surgical procedure and offer benefits to relatives since this condition is inherited in an autosomal dominant manner.

A prospective stratified case-cohort study on statins and multiple adverse events in Japan.

PURPOSE: To assess the association between statins and diverse adverse events in Japanese population. METHODS: New users of statin who started statin after 6-month period of non-use were identified in 68 hospitals between January 2008 and July 2010. In addition to the random sample subcohort, we selected additional subcohort members to make the stratified sample subcohort have at least one patient in all subgroups stratified by each combination of statin and hospital. By abstraction from medical records, detailed information was obtained for all potential cases and pre-selected subcohort members. The event review committee consisting of 3 specialists judged whether possible cases met the definition of one of the adverse events of interest, and for adjudicated cases the committee further judged whether statin was a certain, probable or possible cause of the occurrence of the event. Adjusted for covariates including age, gender, status of "switcher", use of high daily dose and comorbidities at baseline, hazard ratio (HR) was estimated by the Cox proportional hazards model with Barlow's weighting method. Data were also analyzed by the method proposed by Breslow in 2009. RESULTS: A total of 6,877 new users of a statin were identified (median age: 66 years; males: 52%). The hazard ratios of increase in serum creatinine for atorvastatin and fluvastatin have wide confidence intervals, but both of the point estimates were around 2.5. Estimates of hazard ratios by the method of Barlow (1999) were similar to those by the method of Breslow (2009). CONCLUSIONS: Use of statin was not associated with a significant increased risk for renal, liver and muscle events. However, the hazard ratio of increase in serum creatinine tended to be high with atorvastatin and fluvastatin to require further studies.

Effects of pitavastatin and atorvastatin on lipoprotein oxidation biomarkers in patients with dyslipidemia.

OBJECTIVE: The effects of potent statins on oxidized lipoprotein biomarkers are not well defined. METHODS AND RESULTS: The VISION (Value of oxIdant lipid lowering effect by Statin InterventiON in hypercholesterolemia) Trial randomized patients with hypercholesterolemia to 12-week administration of pitavastatin 2 mg/day (n = 21) or atorvastatin 10 mg/day (n = 21) and a variety of lipoprotein oxidative biomarkers were measured. Between-group analysis did not reveal any differences except in the ratio of malondialdehyde (MDA)-LDL over apolipoprotein B-100 (MDA-LDL/apoB) in pitavastatin vs. atorvastatin group (-13% vs. -0.7%, p = 0.04). Within-group changes from baseline to 12-week revealed significant increases in OxPL/apoB and reductions in small-dense LDL, MDA-LDL, and lipoprotein-associated phospholipase A(2) measured on circulating apoB particles (Lp-PLA(2)/apoB) in both groups and significant reductions in OxPL/apoAI in the atorvastatin group. CONCLUSIONS: The VISION study describes the first comparison on lipoprotein oxidation biomarkers between pitavastatin and atorvastatin and suggests diverse effects on lipoprotein oxidation markers in patients with hypercholesterolemia.

Interactions between serum vitamin D levels and vitamin D receptor gene FokI polymorphisms for renal function in patients with type 2 diabetes.

BACKGROUND: We aimed to examine associations among serum 25-hydroxyvitamin D (25OHD) levels, 1,25-dihyroxyvitamin D (1,25OHD) levels, vitamin D receptor (VDR) polymorphisms, and renal function based on estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes. METHODS: In a cross-sectional study of 410 patients, chronic kidney disease (CKD) stage assessed by eGFR was compared with 25OHD, 1,25OHD, and VDR FokI (rs10735810) polymorphisms by an ordered logistic regression model adjusted for the following confounders: disease duration, calendar month, use of angiotensin converting enzyme inhibitors/angiotensin receptor blockers or statins, and serum calcium, phosphate, and intact parathyroid hormone levels. RESULTS: 1,25OHD levels, rather than 25OHD levels, showed seasonal oscillations; peak levels were seen from May to October and the lowest levels were seen from December to February. These findings were evident in patients with CKD stage 3 ~ 5 but not stage 1 ~ 2. eGFR was in direct proportion to both 25OHD and 1,25OHD levels (P<0.0001), but it had stronger linearity with 1,25OHD (r = 0.73) than 25OHD (r = 0.22) levels. Using multivariate analysis, 1,25OHD levels (P<0.001), but not 25OHD levels, were negatively associated with CKD stage. Although FokI polymorphisms by themselves showed no significant associations with CKD stage, a significant interaction between 1,25OHD and FokITT was observed (P = 0.008). The positive association between 1,25OHD and eGFR was steeper in FokICT and CC polymorphisms (r = 0.74) than FokITT polymorphisms (r = 0.65). CONCLUSIONS: These results suggest that higher 1,25OHD levels may be associated with better CKD stages in patients with type 2 diabetes and that this association was modified by FokI polymorphisms.

Management of Elevated Cholesterol in the primary prevention Group of Adult Japanese (MEGA) Study assists the view that a fasting plasma glucose level ≥100 mg/dL increases cardiovascular risk.

UNLABELLED: Aims/Introduction: To evaluate the relationship between fasting plasma glucose (FPG) level and cardiovascular disease in patients with hypercholesterolemia, and to evaluate the effect of pravastatin on risk reduction in a post-hoc analysis of the large-scale Management of Elevated Cholesterol in the primary prevention Group of Adult Japanese (MEGA) Study. MATERIALS AND METHODS: A total of 7832 patients were randomized to diet alone or diet plus low-dose pravastatin (10-20 mg/day, average 8.3 mg during follow-up periods) and followed for >5 years. In this analysis, the relationship between FPG and risk of cardiovascular disease events over 5 years were studied in 6673 patients with recorded baseline FPG levels by using the multivariable Cox proportional hazards model with the restricted quadratic spline based on three knots for FPG quartiles. RESULTS: The spline curve showed an obvious sharp increased risk from a FPG of ≥100 mg/dL. The spline curve in the diet plus pravastatin group was consistently lower than in the diet group, regardless of the FPG level. CONCLUSIONS: The risk of cardiovascular disease appears to increase when FPG is ≥100 mg/dL, with a sharp increased risk found above this level in patients with hypercholesterolemia. Statin treatment seems to be beneficial to reduce cardiovascular disease risk in this population. This trial was registered with ClinicalTrials.gov (no. NCT00211705). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00121.x, 2011).

Astaxanthin suppresses scavenger receptor expression and matrix metalloproteinase activity in macrophages.

BACKGROUND: Astaxanthin is a red carotenoid pigment which has significant potential for antioxidant activity. The macrophages in atherosclerotic lesions, known as activated macrophages, express scavenger receptors responsible for the clearance of pathogenic lipoproteins. In addition, the expression and secretion of proteolytic enzymes, matrix metalloproteinases (MMPs), and pro-inflammatory cytokines are remarkably promoted in activated macrophages. AIM OF THE STUDY: In this study, we investigated the effects of astaxanthin on the expression of scavenger receptors, MMPs, and pro-inflammatory cytokines in macrophages. METHODS: THP-1 macrophages were incubated with 5-10 microM astaxanthin for 24 h. The expression levels of scavenger receptors, MMPs, and pro-inflammatory cytokines were determined by Western blot analysis or real-time RT-PCR. The MMP-9 and -2 activities were examined by gelatin zymography and total MMP activity was measured by fluorometry. RESULTS: We found that astaxanthin remarkably decreased the class A scavenger receptor and CD36 expression in the protein and mRNA levels. Astaxanthin also reduced MMP-1, -2, -3, -9, -12, and -14 activity and expression. The mRNA expression of tumor necrosis factor-alpha, interleukin-1beta, interleukin-6, inducible nitric oxide synthase, and cyclooxygenase-2 were significantly suppressed by astaxanthin. Furthermore, astaxanthin inhibited the phosphorylation of nuclear factor-kappaB. CONCLUSIONS: These results indicate that astaxanthin has inhibitory effects on macrophage activation, such as scavenger receptors up-regulation, MMPs activation, and pro-inflammatory cytokines secretion.

Association of urinary albumin excretion with insulin resistance in Japanese subjects: impact of gender difference on insulin resistance.

OBJECTIVE: To investigate the relationship between homeostasis model assessment for insulin resistance (HOMA-R) and urinary albumin excretion in Japanese and clarify gender difference in albuminuria-related insulin resistance. METHODS: The subject group consisted of 752 Japanese who had no history of diabetes, hypertension or dyslipidemia. After anthropometric examination, fasting blood samples were obtained to determine plasma glucose (FPG), lipids and HOMA-R. The urinary excretion of albumin in the first void urine was expressed as the creatinine ratio (ACR, mg/gCr). Estimated glomerular filtration rate (eGFR) was calculated from serum creatinine using the formula for Japanese. RESULTS: HOMA-R showed a significant correlation with ACR, and the correlation between HOMA-R and ACR was evident in the subjects with central obesity, whereas no significant correlation was found in the non-obese subjects. There was no correlation between HOMA-R and eGFR. HOMA-R increased according to the quintile of ACR and followed a significant trend. This association was obvious in males; however, in females there was no significant trend. Multiple regression analysis revealed that HOMA-R showed a significant correlation with age, waist circumference, blood pressure and serum triglyceride. In addition, ACR exhibited an independent association with HOMA-R. The association of HOMA-R and ACR was observed only in males, and was not present in females. CONCLUSION: Microalbuminuria is associated with insulin resistance in Japanese, where central obesity might play an essential role. This association is gender-specific suggesting the involvement of sex hormones in the pathogenesis of albuminuria-related insulin resistance.

Association of polymorphism of estrogen receptor-alpha gene with circulating levels of adiponectin in postmenopausal women with type 2 diabetes.

AIM: Menopause is a risk factor for cardiovascular disease (CVD) in women because of the reduction in endogenous estrogen. Recently, single nucleotide polymorphisms (SNPs) of the estrogen receptor alpha (ESR-1) gene (c.454-397T>C) associated with the prognosis of myocardial infarction in postmenopausal women were identified; however, the mechanism by which genetic variation of ESR-1 contributes to the pathogenesis of CVD is unknown. Circulating levels of adipokines and inflammatory cytokines predict CVD risk; hence, this study aimed to investigate whether ESR-1 genotypes (c.454-397T>C) might influence circulating levels of adipokines and inflammatory cytokines in postmenopausal women with type 2 diabetes. METHODS: Sixty-three postmenopausal women with type 2 diabetes were recruited. Serum levels of adiponectin, resistin, interleukin-6 (IL-6), and high-sensitive C-reactive protein (hs-CRP) were determined. RESULTS: The genotype of ESR-1 was closely associated with serum adiponectin, which was decreased in subjects with the T allele and was lowest in those with the T/T genotype. Multiple logistic regression analysis revealed independent contribution of the homozygote for the T allele to low serum levels of adiponectin. CONCLUSION: The T allele of the c.454-397T>C SNP of ESR-1 is associated with low serum levels of adiponectin, which may lead to a high risk of CVD in postmenopausal women.

Pravastatin reduces the risk for cardiovascular disease in Japanese hypercholesterolemic patients with impaired fasting glucose or diabetes: diabetes subanalysis of the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study.

Diabetes mellitus (DM) is a major risk factor for cardiovascular disease (CVD) in patients with no history of CVD. Evidence for the effect of statins on CVD in the diabetic population in low-risk populations (e.g., Japanese) is limited. We evaluated the effect of pravastatin on risk reduction of CVD related to baseline glucose status in a primary prevention setting. The Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study, in patients with mild-to-moderate hypercholesterolemia (220-270 mg/dL), showed that low-dose pravastatin significantly reduced the risk for CVD by 26%. This exploratory subanalyses examined the efficacy of diet plus pravastatin on CVD in 2210 patients with abnormal fasting glucose (AFG, including 1746 patients with DM and 464 patients with impaired fasting glucose (IFG) at 5 years in the MEGA Study. CVD was threefold higher in AFG patients (threefold higher in DM, and twofold higher in IFG) compared with normal fasting glucose (NFG) patients in the diet group. Diet plus pravastatin treatment significantly reduced the risk of CVD by 32% (hazard ratio 0.68, 95% CI 0.48-0.96, number needed to treat, 42) in the AFG group compared with the diet alone group, and no significant interaction between AFG and NFG (interaction P=0.85) was found. Safety problems were not observed during long-term treatment with pravastatin. In conclusion, pravastatin reduces the risk of CVD in subjects with hypercholesterolemia and abnormal fasting glucose in the primary prevention setting in Japan.

Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure.

BACKGROUND: The large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. METHODS: In PROBE (Prospective, Randomized, Open, Blinded-Endpoint) design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range) age: 64.5(56.8-71.0)years) with secondary failure of sulfonylurea (SU) were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group) or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group), and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT) of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. RESULTS: After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1-11.3) --> 7.4(6.9-8.7)%, p < 0.01, vs BB;8.9(7.7-10.0) --> 6.9(6.2-7.3)%, p < 0.01), with no significant difference between the groups in percentage change in HbA1c (30 Mix; -14.7(-32.5- (-)7.5)% vs BB -17.8(-30.1- (-)11.1)%, p = 0.32). There was a significant decrease in daily glycemic profile at all points except dinner time in both groups compared to baseline. There was a significant increase in the amount of insulin used in the 30 Mix group after treatment compared to baseline (30 Mix;0.30(0.17-0.44) --> 0.39(0.31-0.42) IU/kg, p = 0.01). There was no significant difference in IMT, BMI, QOL or adiponectin levels in either group compared to baseline. CONCLUSION: Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. TRIAL REGISTRATION: Current Controlled Trials number, NCT00348231.