OBJECTIVES:

To analyze the association between adherence to physical activity guideline recommendations and metabolic control in patients with type 1 diabetes (DM1).

METHODS:

An observational, cross-sectional study was conducted in 130 adult DM1 patients from Spain with a mean age of 33.9±11.5 years and disease duration of 16.5±9.5 years. We analyzed several clinical, anthropometric and laboratory variables together with information obtained from the Minnesota Leisure Time Physical Activity Questionnaire.

RESULTS:

Evaluated patients reported an average of 850.6±493.2min of physical activity per week, being classified as light (567.4±425.4min/week), moderate (169.9±212.1min/week) and intense activities (120.6±184.2). Patients who dedicated more time to intense physical activity were younger, had university studies and were males more often than those who spent none or less time on intense physical activity. We observed no differences in HbA1c levels in relation to time dedicated to moderate physical activities. However, patients who dedicated more than 150min to intense physical activity per week had lower levels of HbA1c (HbA1c: 7.2±1.0% versus 7.8±1.1% versus 8.0±1.0% in more than 149min, between 0 and 149min or 0min of intense physical activity per week, respectively).

CONCLUSION:

Performing more than 150min of intense physical activity a week is associated with better metabolic control in type 1 Spanish patients. No positive impact in metabolic control was observed in relation to the time spent in moderate physical activity.

AIM:

Impaired cerebral vasoreactivity to endothelium-dependent stimuli were described in type 2 diabetes mellitus (T2DM), but the mechanisms underlying that impairment are still unclear. The aim of this study was to investigate the role of cyclooxygenases' metabolites in response to acute hypercapnic stimulus in cerebral vessels, in patients with T2DM.

METHODS:

Vascular responses in the breath-holding test (BHT) were assessed in the absence/presence of a non-selective, reversible-inhibitor of cyclooxygenases, indomethacin (INDO), by functional transcranial Doppler sonography of the middle cerebral artery (N of patients=50; 33 men and 17 women). The functional hemodynamic parameter mean flow velocity (MFV) was assessed at rest, before and 90min after 100mg of INDO, and during the BHT. Breath holding index (BHI) [(MFV at the end of BHT minus MFV at rest)/MFV at rest)×100/s of breath-holding] was calculated after BHT performed before and 90min after INDO.

RESULTS:

MFV at rest significantly decreased after INDO administration compared with a control condition before INDO (at rest before INDO from 49.36±15.09 to 36.72±8.45 after INDO, p<0.001) However, overall cerebral vessel vasoreactivity to hypercapnia, evaluated with BHI, was significantly improved after INDO administration compared with the BHI before INDO administration (from 0.68±0.4 to 1.27±0.42, p<0.001).

CONCLUSIONS:

The improvement in cerebral vasoreactivity in response to BHT after INDO administration suggests that the production of a vasoconstrictor metabolite of cyclooxygenase in diabetic patients was reduced by indomethacin consumption.

OBJECTIVE:

To assess the suitability of HbA1c as a criterion for the diagnosis of diabetes in patients with Graves' disease.

METHODS:

This study enrolled 310 patients with untreated newly diagnosed Graves' disease, 208 patients with euthyroid goiter and 329 age-matched (control) subjects without thyroid disease from Fuzhou, China. The performance of HbA1c against the OGTT for diagnosing diabetes was determined. The Framingham risk score was used to assess general cardiovascular disease (CVD) risk.

RESULTS:

The percentage of patients with abnormal glucose metabolism as classified by HbA1c levels was lower than by OGTT criteria in patients with Graves' disease-33.2% vs. 41.3% for pre-diabetes and 4.5% vs. 11.3% for diabetes, respectively. The sensitivity of HbA1c for diagnosing diabetes in patients with Graves' disease was lower than in patients with euthyroid goiter and subjects without thyroid disease (34.9%, 63.2% and 60.6% respectively), while the specificity was similar (99.3%, 98.6%, 97.4%). Approximately 7.4% of patients with Graves' disease diagnosed with diabetes according to OGTT criteria were misdiagnosed as not having the disease by HbA1c, much higher than that for the other two groups. Patients with Graves' disease with diabetes not diagnosed with the disease by HbA1c showed a high risk for CVD.

CONCLUSIONS:

The low sensitivity of the HbA1c criterion underestimated the percentage of diabetes in patients with Graves' disease. Patients with diabetes who were misdiagnosed as not having the disease by HbA1c were at high risk for CVD.

AIMS:

To compare the efficacy and safety of daily lipoic acid (300-600mg i.v.) plus methylcobalamin (500-1000mg i.v. or im.) (LA-MC) with that of methylcobalamin alone (MC) on diabetic peripheral neuropathy (DPN).

METHODS:

Electronic database were searched for studies published up to November 1, 2012 and study quality was assessed in duplicate. A random or a fixed effect model was used to analyse outcomes which were expressed as risk ratios (RRs) or mean difference (MD). I(2) statistic was used to assess heterogeneity.

RESULTS:

Seventeen studies were included. Combined data from all studies showed that the LA-MC combination therapy was significantly superior to MC monotherapy (RR=1.47; 95% CI: 1.37-1.58). Superiority of the LA-MC combination was shown in nerve conduction velocity (NCV) with WMDs of 6.89 (95% CI: 4.24-9.73) for median motor nerve conduction velocity (MNCV), 5.24 (4.14-6.34) for median sensory nerve conduction velocity (SNCV), 4.34 (3.03-5.64) for peroneal MNCV, and 4.53 (3.2-5.85) for peroneal SNCV. There were no serious adverse events associated with treatment.

CONCLUSIONS:

The results of the meta-analysis show that treatment with LA-MC for 2-4weeks is associated with better outcomes in NCV and neuropathic symptoms relative to MC treatment. However larger well-designed studies are required to confirm this conclusion.

To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Indonesian patients with type 2 diabetes (T2D) as part of the 24-week, international, prospective, non-interventional A1chieve study.Indonesian patients who started BIAsp 30 were included. Safety and efficacy was measured as part of routine clinical practice at baseline, Week 12 and Week 24. Results: Overall, 1324 patients having a mean±SD age, duration of diabetes and body mass index of 55.2±9.9 yrs, 6.8±5.2 yrs and 24.1±3.6kg/m(2), respectively, were enrolled. 67% of patients were insulin-naive and 33% were prior insulin users. Glycaemic control was poor at baseline. After 24 weeks, significant reductions from baseline were observed in the mean glycated haemoglobin A1c (HbA1c) (-2.6%), fasting plasma glucose (-93.8 mg/dL) and postprandial plasma glucose (-134.8 mg/dL) levels in the entire cohort (p < 0.001). Significant reductions were also seen in insulin-naive patients and prior insulin users. At Week 24, 29.9% of patients in the entire cohort achieved target HbA1c level of <7.0%, while 26.7% and 39.2% achieved this target among insulin-naive patients and prior insulin users, respectively. The proportion of patients reporting overall hypoglycaemia significantly decreased in the entire cohort after 24 weeks of BIAsp 30 therapy. A small significant increase in body weight was noted in the entire cohort, insulin-naive patients and prior insulin users.The current study suggests that BIAsp 30 can be considered as a safe and effective option for initiating as well as intensifying insulin therapy in Indonesian patients with T2D.

To determine the safety and efficacy of insulin detemir in Indonesian patients with type 2 diabetes (T2D) as a sub-analysis of the 24-week, prospective, multinational, non-interventional A1chieve study.This study included 477 Indonesian T2D patients starting insulin detemir at the discretion of their physicians. Safety and efficacy was measured in routine clinical practice at baseline, interim (around 12 weeks from baseline) and final (around 24 weeks from baseline) visit.At baseline the mean age, duration of diabetes and mean BMI were 55.3±8.5 years, 5.9±4.0 years and 24±3.6kg/m(2), respectively. Of these patients, 78% were insulin-naive and 22% were prior insulin users. Glycaemic control was poor at baseline. After 24 weeks, significant reductions were observed in mean HbA1c (2.2%, p < 0.001), fasting plasma glucose (90.0 mg/dL, p < 0.001) and postprandial plasma glucose (115.4 mg/dL, p < 0.001) levels, in the entire cohort. Similar significant reductions were also seen in insulin-naive patients and prior insulin users. In the entire cohort, 32.5% patients achieved HbA1c levels <7.0% while 32.0% insulin-naive patients and 33.9% prior insulin users achieved this target after 24 weeks. No hypoglycaemic events were reported in the entire cohort. Modest increase in body weight was noted in the insulin-naive group, while mean body weight decreased in prior insulin users after 24 weeks of insulin detemir therapy.This sub-analysis suggests that insulin detemir can be a safe and effective option for initiating insulin therapy in people with T2D in Indonesia.

To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Indonesian type 2 diabetes patients switched from biphasic human insulin 30 (BHI 30) as a sub-analysis of the A1chieve study.Clinical safety and effectiveness over 24 weeks was evaluated in Indonesian patients who switched from BHI 30 to BIAsp 30 at the discretion of their physician.A total of 244 patients with mean age ± SD 55.6±9.5 years, BMI 24.6±3.8kg/m(2), and mean diabetes duration 7.8±5.7 years were included. The mean pre-study BHI 30 dose was 0.56±0.25 IU/kg and the baseline BIAsp 30 dose was 0.60±0.26U/kg titrated up to 0.65±0.25 U/kg by Week 24. No serious adverse drug reactions were reported throughout the study. Overall hypoglycaemia decreased from 2.18 to 0.06 events/patient-year with a significant decrease in the proportion of patients affected (p < 0.0001). No nocturnal or major hypoglycaemia was reported at Week 24. HbA1c improved from 8.8±1.2% at baseline to 7.3±0.8% at Week 24. A total of 45 patients achieved HbA1c <7.0% as compared to 5 patients with HbA1c <7.0% at baseline. FPG and PPPG improved significantly after 24 weeks (p < 0.001). Quality of life was positively impacted (change in visual analogue scores, 3.0±11.6 points, p < 0.001).Switching from BHI 30 to BIAsp 30 in this Indonesian cohort was well-tolerated and improved glycaemic control with a decreased risk of hypoglycaemia.

To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Filipino patients with type 2 diabetes previously treated with biphasic human insulin 30 (BHI 30). Methods: Safety and effectiveness outcomes were measured in all patients switching from BHI 30 to BIAsp 30 in the Filipino cohort of the 24-week, multinational, prospective, non-interventional A1chieve study.A total of 111 Filipino patients (mean age ± SD, 57.4±12.8 years; BMI, 25.8±5.6kg/m(2)) with mean diabetes duration of 9.9±7.1 years switched therapy from BHI 30 to BIAsp 30. The mean pre-study BHI 30 dose was 0.65±0.28 IU/kg and the baseline BIAsp 30 dose was 0.65±0.26 U/kg titrated up to 0.70±0.26 U/kg by Week 24. No serious adverse drug reactions were reported. Overall hypoglycaemia was reduced from 5.62 to 1.98 events/patient-year. Minor and nocturnal hypoglycaemia decreased and no major hypoglycaemia was reported at Week 24. Glucose control improved from baseline to Week 24 (HbA1c, -2.2±2.1% [24±23 mmol/mol]; FPG, -72.0±71.8 mg/dL; PPPG, -145.5±125.4 mg/dL). A total of 24 patients achieved HbA1c levels <7.0% at Week 24 compared to 6 patients reporting this target at baseline. Quality of life was positively impacted at Week 24 (change in visual analogue scores, 15.3±16.9 points).Switching from BHI 30 to BIAsp 30 improved glycaemic control without increasing the risk of hypoglycaemia.

To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) therapy in Bangladeshi type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) as a sub-analysis of the A1chieve study.Bangladeshi patients switched from BHI to BIAsp 30 at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary outcomes comprised changes from baseline to Week 24 in the number of hypoglycaemic events, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), systolic blood pressure and body weight. Quality of life (QoL) was evaluated at baseline and Week 24 using the EQ-5D questionnaire.A total of 82 patients (mean age ± SD: 52.3±12.2 years; body mass index: 25.6±3.3kg/m(2)) with a mean diabetes duration of 9.5±5.5 years and mean duration on insulin of 2.5±2.4 years were included. The mean BIAsp 30 dose was 0.49±0.20 U/kg at baseline and 0.47±0.17 U/kg at Week 24. No SADRs were reported. No events of hypoglycaemia (overall, major, minor or nocturnal) were reported at Week 24. Mean HbA1c, FPG and PPPG levels improved by -2.5±1.3%, -65.0±31.8 mg/dL and -119.3±48.7 mg/dL, respectively, over 24 weeks. QoL also improved (mean change from baseline: +28.5±12.9 points).Switching from BHI to BIAsp 30 therapy improved blood glucose control and was well-tolerated in this Bangladeshi subgroup.

To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in the ASEAN cohort of the A1chieve study.Type 2 diabetes patients from Indonesia, Malaysia, Philippines and Singapore prescribed BIAsp 30 therapy were included. The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary outcomes were changes in hypoglycaemic events, serious adverse events (SAEs) and effectiveness parameters.This sub-analysis included 2798 patients (insulin-naive, 1903; insulin-experienced, 895) with mean age ± SD, 55.3±10.8 years, BMI, 24.9±4.6kg/m(2) and diabetes duration, 7.5±5.9 years. Baseline HbA1c in the entire cohort was poor (9.9%, 85 mmol/mol). A total of 15 SAEs were reported in 7 insulin-experienced patients (1 moderate event was related to BIAsp 30). Overall hypoglycaemia at Week 24 was 0.88 events/patient-year compared to 1.71 events/patient-year reported at baseline (change in proportion of patients affected, p < 0.0001). No major hypoglycaemia was reported at Week 24. BIAsp 30 significantly improved glucose control (HbA1c, fasting plasma glucose and postprandial plasma glucose, p < 0.001) at Week 24. The proportion of patients achieving HbA1c <7.0% at Week 24 was 35.3% compared to 3.5% at baseline. The lipid profile and systolic blood pressure also improved significantly (p < 0.001). Quality of life was positively impacted (mean change in visual analogue scores from EQ-5D = 10.6±13.8 points, p < 0.001).BIAsp 30 was well-tolerated and improved glucose control while decreasing the risk of hypoglycaemia.