Medication use before and after bariatric surgery: 5-year results from a randomised controlled trial of banded Roux-en-Y gastric bypass versus sleeve gastrectomy in patients with obesity and type 2 diabetes.

AIM: Bariatric surgery is an effective tool for weight loss and for improving weight related co-morbidities. Changes in medication usage after a silastic ring laparoscopic Roux-en-Y gastric bypass (SR-LRYGB) compared with laparoscopic sleeve gastrectomy (LSG) are unknown. METHODS: This was a single-centre, double-blind, randomised controlled trial. Patients were randomised to either SR-LRYGB or LSG. A medication history was obtained at regular follow-up intervals, and mean numbers of prescribed medications were analysed over 5 years. Poisson regression and generalised estimating equations were used to test for statistically significant changes in usage. RESULTS: After eight patients were lost to follow-up, data from 52 patients in each group were available for analysis. There was no difference between the SR-LRYGB or LSG groups in the number of medications prescribed, with the exception of oral glucose-lowering medications, where there was a greater decrease after SR-LRYGB compared to LSG (79% vs 55% respectively) from baseline to 5 years. At 5 years, total medication prescribed was down 10% from pre-operative levels. Prescribed insulin decreased by 72%, and cardiovascular medication decreased by 56% compared to baseline. Prescriptions for analgesia increased by 50%, psychiatric medications by 133% and proton-pump inhibitors by 81%. CONCLUSION: Both SR-LRYGB and LSG reduced requirement for diabetic and cardiovascular medications, but increased requirement for nutritional supplementation, analgesia and psychiatric medications. There was a greater reduction in oral anti-diabetic medication prescriptions following SR-LRYGB compared to LSG, but no other difference in medication usage between surgical groups was found.

All-cause, premature, and cardiovascular death attributable to socioeconomic and ethnic disparities among New Zealanders with type 1 diabetes 1994-2019: a multi-linked population-based cohort study.

BACKGROUND: New Zealand (NZ) research into type 1 diabetes mellitus (T1DM) mortality can inform policy and future research. In this study we aimed to quantify the magnitude to which ethnicity and socioeconomic disparities influenced mortality at the population level among people with Type 1 diabetes (T1DM) in Auckland, New Zealand (NZ). METHODS: The cohort data were derived from the primary care diabetes audit program the Diabetes Care Support Service (DCSS), and linked with national primary care, pharmaceutical claims, hospitalisation, and death registration databases. People with T1DM enrolled in DCSS between 1994-2018 were included. All-cause, premature, and cardiovascular mortalities were estimated by Poisson regression models with adjustment for population-level confounders. The mortality rates ratio (MRR) was standardized against the DCSS type 2 diabetes population. Mortality rates were compared by ethnic group (NZ European (NZE) and non-NZE) and socioeconomic deprivation quintile. The population attributable fraction (PAF) was estimated for ethnic and socioeconomic disparities by Cox regression adjusting for demographic, lifestyle, and clinical covariates. The adjusted slope index inequality (SII) and relative index of inequality (RII) were used to measure the socioeconomic disparity in mortalities. RESULTS: Overall, 2395 people with T1DM (median age 34.6 years; 45% female; 69% NZE) were enrolled, among whom the all-cause, premature and CVD mortalities were 6.69 (95% confidence interval: 5.93-7.53), 3.30 (2.77-3.90) and 1.77 (1.39-2.23) per 1,000 person-years over 25 years. The overall MRR was 0.39 (0.34-0.45), 0.65 (0.52-0.80), and 0.31 (0.24-0.41) for all-cause, premature and CVD mortality, respectively. PAF attributable to ethnicity disparity was not significantly different for mortality. The adjusted PAF indicated that 25.74 (0.84-44.39)% of all-cause mortality, 25.88 (0.69-44.69)% of premature mortality, 55.89 (1.20-80.31)% of CVD mortality could be attributed to socioeconomic inequality. The SII was 8.04 (6.30-9.78), 4.81 (3.60-6.02), 2.70 (1.82-3.59) per 1,000 person-years and RII was 2.20 (1.94-2.46), 2.46 (2.09-2.82), and 2.53 (2.03-3.03) for all-cause, premature and CVD mortality, respectively. CONCLUSIONS: Our results suggest that socioeconomic disparities were responsible for a substantial proportion of all-cause, premature and CVD mortality in people with T1DM in Auckland, NZ. Reducing socioeconomic barriers to management and self-management would likely improve clinical outcomes.

Health Inequality in Eight Adverse Outcomes Over a 25-Year Period in a Multi-Ethnic Population in New Zealand Population with Impaired Glucose Tolerance and/or Impaired Fasting Glucose: An Age-Period-Cohort Analysis.

Purpose: We aimed to examine socioeconomic inequality (SI) in cause-specific outcomes among adults with impaired glucose tolerance (IGT) and/or Impaired fasting glucose (IFG) in New Zealand (NZ) over 25 years. Patients and Methods: A population-based open cohort was derived from Diabetes Care Support Service in NZ with national databases linkage. Patients aged ≥18 years with IGT and/or IFG were enrolled between 01/01/1994 and 31/07/2018 and followed up until death or 31/12/2018. Incident outcomes (all-cause, premature, cardiovascular, and cancer death; cardiovascular, myocardial infarction, stroke, heart failure, and end-stage kidney disease hospitalization) by demographic, anthropometric, socioeconomic status, clinical measurements, enrol-time-periods, and IGT/IFG were evaluated. Adjusted incidence rate ratios, absolute risk difference, and SI measurements (slope and relative index of inequality) were estimated using Age-Period-Cohort models. Results: 29,894 patients (58.5 (SD 14.3) years mean age; 52.2% female) were enrolled with 5.6 (IQR: 4.4-7.4) years of median follow-up. Mortality rates decreased, whereas hospitalization (except myocardial infarction) rates increased. SI was significant for each outcome. Higher mortality and hospitalization rates and worsened SI were common in men, older, the most deprived, and Maori patients, as well as patients with obesity, current smoking, with both IFG and IGT, and greater metabolic derangement (higher systolic blood pressure, lipids, and HbA1c, and lower level of mean arterial pressure). Conclusion: Enhanced management strategies are necessary for people with IGT and/or IFG to address persisting SI, especially for men, older people, current smokers, NZ European and Maori patients, patients with obesity, or with any abnormal metabolic measurements.

Association Between Onset of Type 2 Diabetes and Risk of Atrial Fibrillation in New Zealanders With Impaired Glucose Tolerance Over 25 Years.

Background The association between the onset of type 2 diabetes (T2D) and atrial fibrillation (AF) risk in individuals with impaired glucose tolerance (IGT) remains unclear. This study aimed to investigate the relationship between the incident onset of T2D and 5- and 10-year (after the landmark period) risks of AF in people with IGT identified in South and West Auckland primary care settings between 1994 and 2019. Methods and Results We compared AF risk in patients with IGT with and without newly diagnosed T2D within a 1- to 5-year exposure window. Tapered matching and landmark analysis (to address immortal bias) were used to control for confounding variables. The cohorts incorporated 785 patients who had T2D newly diagnosed within 5 years from enrollment (landmark date) and 15 079 patients without a T2D diagnosis. Patients progressing to T2D exhibited significantly higher 5-year (after the landmark period) AF risk (hazard ratio [HR], 1.34 [95% CI, 1.10-1.63]) and 10-year (after the landmark period) AF risk (HR, 1.28 [95% CI, 1.02-1.62]) compared with those without incident T2D. The association was more pronounced among men, older patients, socioeconomically deprived individuals, current smokers, those with higher metabolic measures, and lower renal function. New Zealand European ethnicity was associated with a lower 5- and 10-year risk of AF. Conclusions This study found a mediating effect of T2D on the risk of AF in a population with IGT in New Zealand. The development of risk scores and future replication studies can help identify and guide management of individuals with IGT at the highest risk of AF following incident T2D.

Adverse Clinical Outcomes Attributable to Socioeconomic and Ethnic Disparities Among People with Type 2 Diabetes in New Zealand Between 1994-2018: A Multiple Linked Cohort Study.

Purpose: The study aimed to examine the separate population-level contributions of the ethnic and socioeconomic disparities among people with type 2 diabetes mellitus (T2DM) and residence in New Zealand (NZ). Patients and Methods: A prospective cohort enrolled T2DM patients from 01/01/1994 into the Diabetes Care Support Service, a primary care audit program in Auckland, NZ. The cohort was linked to national registry databases (socioeconomic status, pharmaceutical claim, hospitalization, and death registration). Each cohort member was followed up till death or the study end time (31/12/2019), whichever came first. Incident clinical events (stroke, myocardial infarction (MI), heart failure (HF), end-stage renal disease (ESRD), and premature mortality (PM)) were used as outcomes. The attributable fractions (AFs) were estimated for the whole population and for specific population with NZ Europeans (NZE) and/or least deprived population as reference, both unadjusted and with adjustment for covariables by Cox Regression models. Results: Among 36,267 patients, adjusted population AFs indicated 6.6(-30.8-33.3)% of PM, 17.1(5.8-27.0)% of MI, 35.3(22.6-46.0)% of stroke, 14.3(3.2-24.2)% of HF, and 15.9(6.7-24.2)% of ESRD could be attributed to deprivation; while 14.3(3.3-25.4)% of PM, -3.3(-8.3-1.5)% of MI, -0.5(-6.7-5.3)% of stroke, 4.7(0.3-8.8)% of HF, 13.3(9.9-16.6)% of ESRD could be attributed to ethnicity. Deprivation contributed a significant AF to stroke, while ethnicity was important for ESRD. Gradient of AF for deprivation indicated NZE and Asians were most affected by deprivation across outcomes. Conversely, Maori, with the highest AFs for ethnicity of PM and ESRD, were unaffected by deprivation. At same deprivations, the AFs of MI and stroke were greatest among NZE compared with other ethnic groups; the AF of ESRD was greatest among Maori and Pasifika. Conclusion: Both socioeconomic deprivation and ethnicity are strongly associated with outcomes in patients with T2DM in NZ, although the extent of the deprivation gradient is greatest among NZE and Asians, and least among Maori.

Ethnic differences in 25-year risk of incident chronic kidney disease among people with type 2 diabetes in New Zealand.

INTRODUCTION: Insights into ethnic differences in the natural history of chronic kidney disease (CKD) among people with type 2 diabetes mellitus (T2DM) might inform clinical strategies to address disparities in hospitalization and mortality. Risks of CKD II-V stages over a 25-year period between New Zealand Europeans (NZEs), Maori and Pasifika, and with T2DM in Auckland, New Zealand (NZ) were compared. RESEARCH DESIGN AND METHODS: As a primary care audit program in Auckland, the Diabetes Care Support Service was linked with national registration databases. People with existing CKD II-V were ruled out. To balance potential confounders, we applied a tapered matching method . 'Quasi-trial'-matched cohorts were set up separately between Maori and NZE and between Pasifika and NZE. Ethnic population differences in risk of any and each stage of CKD over 1994-2018 were examined by weighted Cox regression model. RESULTS: The HRs for developing any CKD, CKD stages II-V for Maori (n=2215) versus NZE (n=2028) were 1.18 (95% CI 0.99 to 1.41), 1.10 (95% CI 0.91 to 1.32), 1.70 (95% CI 1.19 to 2.43), 3.93 (95% CI 2.16 to 7.14), and 3.74 (95% CI 1.74 to 8.05), respectively. Compared with NZE (n=2474), the HRs for developing any CKD, CKD stages II-V for Pasifika (n=3101) were 1.31 (95% CI 1.09 to 1.57), 1.26 (95% CI 1.05 to 1.52), 1.71 (95% CI 1.14 to 2.57), 3.75 (95% CI 1.40 to 10.05), and 4.96 (95% CI 1.56 to 15.75), respectively. CONCLUSIONS: Among people with T2DM in NZ, significant ethnic differences exist in the risk of progressing to each stage of CKD (stage V in particular). Mechanism studies underlying these differences, as well as the need for identification of biomarkers to predict the early onset renal lesion, are warranted.

Effect of Banded Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy on Diabetes Remission at 5 Years Among Patients With Obesity and Type 2 Diabetes: A Blinded Randomized Clinical Trial.

OBJECTIVE: To determine whether silastic ring laparoscopic Roux-en-Y gastric bypass (SR-LRYGB) or laparoscopic sleeve gastrectomy (LSG) produces superior diabetes remission at 5 years. RESEARCH DESIGN AND METHODS: In a single-center, double-blind trial, 114 adults with type 2 diabetes and BMI 35-65 kg/m2 were randomly assigned to SR-LRYGB or LSG (1:1; stratified by age-group, BMI group, ethnicity, diabetes duration, and insulin therapy) using a web-based service. Diabetes and other metabolic medications were adjusted according to a prespecified protocol. The primary outcome was diabetes remission assessed at 5 years, defined by HbA1c <6% (42 mmol/mol) without glucose-lowering medications. Secondary outcomes included changes in weight, cardiometabolic risk factors, quality of life, and adverse events. RESULTS: Diabetes remission after SR-LRYGB versus LSG occurred in 25 (47%) of 53 vs. 18 (33%) of 55 patients (adjusted odds ratios 4.5 [95% CI 1.6, 15.5; P = 0.009] and 4.2 [1.3, 13.4; P = 0.015] in the intention-to-treat analysis). Percent body weight loss was greater after SR-LRYGB than after LSG (absolute difference 10.7%; 95% CI 7.3, 14.0; P < 0.001). Improvements in cardiometabolic risk factors were similar, but HDL cholesterol increased more after SR-LRYGB. Early and late complications were similar in both groups. General health and physical functioning improved after both types of surgery, with greater improvement in physical functioning after SR-LRYGB. People of Maori or Pacific ethnicity (26%) had lower incidence of diabetes remission than those of New Zealand European or other ethnicities (2 of 25 vs. 41 of 83; P < 0.001). CONCLUSIONS: SR-LRYGB provided superior diabetes remission and weight loss compared with LSG at 5 years, with similar low risks of complications.

Ethnic differences in metabolic achievement between Maori, Pacific, and European New Zealanders with type 2 diabetes.

AIMS: To compare variations in metabolic target achievement by ethnicity (Europeans, Maori and Pasifika) among patients with type 2 diabetes (T2DM) in Auckland, New Zealand (NZ) between 1994 and 2013. METHODS: 32,237 patients were enrolled. Adjusted marginal difference (European as reference) of systolic blood pressure (SBP), body mass index (BMI), HbA1c and total cholesterol, alongside the proportion achieving metabolic targets were estimated using multivariable mixed effect models at baseline, 1-, 2-, 3-, 4-, and 5-years, adjusted for covariates. RESULTS: Compared with Europeans, Maori and Pasifika had continuously, significantly higher HbA1c (by 0.3% (+3.5 mmol/mol) and 0.6% (+6.8 mmol/mol) respectively and BMI (+1.5 and +0.3 kg/m2 respectively) but lower SBP (-1.8 and -3.4 mmHg respectively) and TG (-0.03 and -0.34 mmol/L respectively), and insignificantly TC (+0.004 and +0.01 respectively), by 5-years of follow-up. While 49% Europeans were within target HbA1c, this was achieved by only 30% Maori and 27% Pasifika. Conversely, 41% Europeans, 46% Maori and 59% Pasifika achieved the SBP target (all P < 0.0001). CONCLUSIONS: Managing hyperglycemia appears to be more challenging than treating hypertension and dyslipidemia among Maori and Pasifika. New anti-hyperglycemia treatments, addressing health literacy, socioeconomic and any cultural barriers to management and self-management are urgently needed to reduce these disparities.

Ethnic Differences in Cancer Rates Among Adults With Type 2 Diabetes in New Zealand From 1994 to 2018.

Importance: People with type 2 diabetes have greater risk for some site-specific cancers, and risks of cancers differ among racial and ethnic groups in the general population of Aotearoa New Zealand. The extent of ethnic disparities in cancer risks among people with type 2 diabetes in New Zealand is unclear. Objective: To compare the risks of 21 common adult cancers among Maori, Pasifika, and New Zealand European individuals with type 2 diabetes in New Zealand from 1994 to 2018. Design, Setting, and Participants: This population-based, matched cohort study used data from the primary care audit program in Auckland, New Zealand, linked with national cancer, death, and hospitalization registration databases, collected from January 1, 1994, to July 31, 2018, with follow-up data obtained through December 31, 2019. Using a tapered matching method to balance potential confounders (sociodemographic characteristics, lifestyle, anthropometric and clinical measurements, treatments [antidiabetes, antihypertensive, lipid-lowering, and anticoagulant], period effects, and recorded duration of diabetes), comparative cohorts were formed between New Zealand European and Maori and New Zealand European and Pasifika individuals aged 18 years or older with type 2 diabetes. Sex-specific matched cohorts were formed for sex-specific cancers. Exposures: Maori, Pasifika, and New Zealand European (reference group) ethnicity. Main Outcomes and Measures: The incidence rates of 21 common cancers recorded in nationally linked databases between 1994 and 2018 were the main outcomes. Weighted Cox proportional hazards regression was used to assess ethnic differences in risk of each cancer. Results: A total of 33 524 adults were included: 15 469 New Zealand European (mean [SD] age, 61.6 [13.2] years; 8522 [55.1%] male), 6656 Maori (mean [SD] age, 51.2 [12.4] years; 3345 [50.3%] female), and 11 399 Pasifika (mean [SD] age, 52.8 [12.7] years; 5994 [52.6%] female) individuals. In the matched New Zealand European and Maori cohort (New Zealand European: 8361 individuals; mean [SD] age, 58.9 [12.9] years; 4595 [55.0%] male; Maori: 5039 individuals; mean [SD] age, 51.4 [12.3] years; 2542 [50.5%] male), significant differences between New Zealand European and Maori individuals were identified in the risk for 7 cancers. Compared with New Zealand European individuals, the hazard ratios (HRs) among Maori individuals were 15.36 (95% CI, 4.50-52.34) for thyroid cancer, 7.94 (95% CI, 1.57-40.24) for gallbladder cancer, 4.81 (95% CI, 1.08-21.42) for cervical cancer (females only), 1.97 (95% CI, 1.30-2.99) for lung cancer, 1.81 (95% CI, 1.08-3.03) for liver cancer, 0.56 (95% CI, 0.35-0.90) for colon cancer, and 0.11 (95% CI, 0.04-0.27) for malignant melanoma. In the matched New Zealand European and Pasifika cohort (New Zealand European: 9340 individuals; mean [SD] age, 60.6 [13.1] years; 4885 [52.3%] male; Pasifika: 8828 individuals; mean [SD] age, 53.1 [12.6] years; 4612 [52.2%] female), significant differences between New Zealand European and Pasifika individuals were identified for 6 cancers. Compared with New Zealand European individuals, HRs among Pasifika individuals were 25.10 (95% CI, 3.14-200.63) for gallbladder cancer, 4.47 (95% CI, 1.25-16.03) for thyroid cancer, 0.48 (95% CI, 0.30-0.78) for colon cancer, 0.21 (95% CI, 0.09-0.48) for rectal cancer, 0.21 (95% CI, 0.07-0.65) for malignant melanoma, and 0.01 (95% CI, 0.01-0.10) for bladder cancer. Conclusions and Relevance: In this cohort study, differences in the risk of 21 common cancers were found between New Zealand European, Maori, and Pasifika groups of adults with type 2 diabetes in New Zealand from 1994 to 2018. Research into the mechanisms underlying these differences as well as additional screening strategies (eg, for thyroid and gallbladder cancers) appear to be warranted.

Ethnic differences in mortality and hospital admission rates between Maori, Pacific, and European New Zealanders with type 2 diabetes between 1994 and 2018: a retrospective, population-based, longitudinal cohort study.

BACKGROUND: Type 2 diabetes affects Indigenous and non-European populations disproportionately, including in New Zealand, where long-term temporal trends in cause-specific clinical outcomes between Maori, Pacific, and European people remain unclear. We aimed to compare the rates of mortality and hospital admission between Maori, Pacific, and European patients with type 2 diabetes in Auckland, New Zealand, over a period of 24 years. METHODS: In this retrospective, population-based, longitudinal cohort study, we identified a cohort of patients (aged 35-84 years) with type 2 diabetes enrolled between Jan 1, 1994, and July 31, 2018, to the primary care audit programme, the Diabetes Care Support Service (DCSS) in Auckland, New Zealand. Patients with type 1 diabetes, prediabetes, and gestational diabetes were excluded. We linked data from the DCSS with national death registration, hospital admission, pharmaceutical claim, and socioeconomic status databases. Patients were followed up until death or July 31, 2018 (date of last enrolment to the DCSS). Incident clinical events (all-cause mortality, cardiovascular mortality, cancer mortality, cardiovascular hospital admission, cancer hospital admission, and end-stage renal disease hospital admission) were identified. Event rates were stratified by ethnic group, age group, sex, socioeconomic status, and time period (<1998, 1999-2013, 2004-08, 2009-13, and 2014-18). Incidence rate ratios (IRRs) and absolute risk differences were adjusted for sex, age, smoking status, obesity, socioeconomic status, and time period by use of age-period-cohort modelling. FINDINGS: Between Jan 1, 1994, and July 31, 2018, 45 072 patients with type 2 diabetes (21 936 [48·7%] female; mean age 56·7 years [SD 13·8]) were enrolled in the DCSS and followed up for a median of 9·7 years (IQR 5·8-13·6). 16 755 (37·2%) were European, 7093 (15·7%) were Maori, and 12 044 (26·7%) were Pacific patients. Despite a similar temporal trend (decreasing mortality and increasing hospital admissions) across the three ethnic groups, Maori and Pacific patients had consistently higher hospital admission rates than European patients. Maori but not Pacific patients had higher adjusted IRRs for all-cause mortality (1·96 [95% CI 1·80-2·14]), cardiovascular mortality (1·93 [1·63-2·29]) and cancer mortality (1·64 [1·40-1·93]) rates compared with European patients. INTERPRETATION: Compared with European patients, poorer health outcomes have persisted among Maori and Pacific people with type 2 diabetes for more than 20 years. New policies supporting prevention and more intensive management of type 2 diabetes are urgently needed. Research into the biological and societal mechanisms underlying these disparities, and the associated differences between Maori and Pacific patients is also needed. FUNDING: Counties Manukau Health and Middlemore Foundation.

Good Glycemic Outcomes Following Bariatric Surgery Among Patients With Type 2 Diabetes, Obesity, and Low-Titer GAD Antibodies.

OBJECTIVE: To evaluate diabetes remission after bariatric surgery by presence of GAD antibody among those with obesity and type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: Screening GAD was performed in 221 patients with T2D and obesity referred for bariatric surgery. Nine of 16 patients with GAD and 112 of 205 without GAD proceeded with surgery. Diabetes remission and weight loss were compared by GAD presence. RESULTS: The group with GAD had levels 16-91 IU/mL. Those with and without GAD were similar with regard to age, BMI, diabetes duration, proportion treated with insulin, HbA1c, and C-peptide (1,354 ± 548 vs. 1,358 ± 487 pmol/L). At 1 and 5 years postoperatively, the two groups achieved similar BMI reduction and diabetes remission (67% vs. 73%, P = 0.71, and 56% vs. 57%, P = 1.0). CONCLUSIONS: Low-titer GAD in patients with T2D and retained C-peptide should not be a deterrent for bariatric surgery when the principal aim is diabetes remission.

Persistent postural daily headaches.

Fifty-five year-old female presented with five weeks of progressively worsening headaches precipitated by a sudden neck movement. The headaches were exacerbated by sitting up or standing. There was associated diplopia and facial pain. Investigations were consistent with intracranial hypotension with a possible spontaneous spinal cerebrospinal fluid leak. Symptoms improved dramatically after an epidural blood patch.

Effectiveness of text message based, diabetes self management support programme (SMS4BG): two arm, parallel randomised controlled trial.

OBJECTIVE: To determine the effectiveness of a theoretically based and individually tailored, text message based, diabetes self management support intervention (SMS4BG) in adults with poorly controlled diabetes. DESIGN: Nine month, two arm, parallel randomised controlled trial. SETTING: Primary and secondary healthcare services in New Zealand. PARTICIPANTS: 366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c ≥65 mmol/mol or 8%) randomised between June 2015 and November 2016 (n=183 intervention, n=183 control). INTERVENTIONS: The intervention group received a tailored package of text messages for up to nine months in addition to usual care. Text messages provided information, support, motivation, and reminders related to diabetes self management and lifestyle behaviours. The control group received usual care. Messages were delivered by a specifically designed automated content management system. MAIN OUTCOME MEASURES: Primary outcome measure was change in glycaemic control (HbA1c) from baseline to nine months. Secondary outcomes included change in HbA1c at three and six months, and self efficacy, diabetes self care behaviours, diabetes distress, perceptions and beliefs about diabetes, health related quality of life, perceived support for diabetes management, and intervention engagement and satisfaction at nine months. Regression models adjusted for baseline outcome, health district category, diabetes type, and ethnicity. RESULTS: The reduction in HbA1c at nine months was significantly greater in the intervention group (mean -8.85 mmol/mol (standard deviation 14.84)) than in the control group (-3.96 mmol/mol (17.02); adjusted mean difference -4.23 (95% confidence interval -7.30 to -1.15), P=0.007). Of 21 secondary outcomes, only four showed statistically significant improvements in favour of the intervention group at nine months. Significant improvements were seen for foot care behaviour (adjusted mean difference 0.85 (95% confidence interval 0.40 to 1.29), P<0.001), overall diabetes support (0.26 (0.03 to 0.50), P=0.03), health status on the EQ-5D visual analogue scale (4.38 (0.44 to 8.33), P=0.03), and perceptions of illness identity (-0.54 (-1.04 to -0.03), P=0.04). High levels of satisfaction with SMS4BG were found, with 161 (95%) of 169 participants reporting it to be useful, and 164 (97%) willing to recommend the programme to other people with diabetes. CONCLUSION: A tailored, text message based, self management support programme resulted in modest improvements in glycaemic control in adults with poorly controlled diabetes. Although the clinical significance of these results is unclear, the findings support further investigation into the use of SMS4BG and other text message based support for this patient population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614001232628.

Laparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial.

BACKGROUND: There are very few randomised, blinded trials comparing laparoscopic sleeve gastrectomy (LSG) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) in achieving remission of type 2 diabetes (T2D), particularly silastic ring (SR)-LRYGB. We compared the effectiveness of (LSG) versus SR-LRYGB among patients with T2D and morbid obesity. METHODS: Prospective, randomised, parallel, 2-arm, blinded clinical trial conducted in a single Auckland (New Zealand) centre. Eligible patients aged 20-55 years, T2D of at least 6 months duration and BMI 35-65 kg/m2 were randomised 1:1 to LSG (n = 58) or SR-LRYGB (n = 56) using random number codes disclosed after anaesthesia induction. Primary outcome was T2D remission defined by different HbA1c thresholds at 1 year. Secondary outcomes included weight loss, quality of life, anxiety and depressive symptoms, post-operative complications and mortality. RESULTS: Mean ± standard deviation (SD) pre-operative BMI was 42.5 ± 6.2 kg/m2, HbA1c 63 ± 16 mmol/mol (30% insulin-treated, 28% had diabetes duration over 10 years). Proportions achieving HbA1c ≤ 38 mmol/mol, < 42 mmol/mol, < 48 mmol/mol and < 53 mmol/mol without diabetes medication at 1 year in SR-LRYGB vs LSG were 38 vs 43% (p = 0.56), 52 vs 49% (p = 0.85), 75 vs 72% (p = 0.83) and 80 vs 77% (p = 0.82), respectively. Mean ± SD % total weight loss at 1 year was greater after SR-LRYGB than LSG: 32.2 ± 7.7 vs 27.1 ± 7.5%, respectively (p < 0.001). Gastrointestinal complications were more frequent after SR-LRYGB (including 3 ulcers, 1 anastomotic leak, 1 abdominal bleeding). Quality of life and depression symptoms improved significantly in both groups. CONCLUSION: Despite significantly greater weight loss after SR-LRYGB, there was similar T2D remission and psychosocial improvement after LSG and SR-LRYGB at 1 year. TRIAL REGISTRATION: Prospectively registered at Australia and New Zealand Clinical Trials Register (ACTRN 12611000751976) and retrospectively registered at Clinical Trials (NCT1486680).

Use of 50/50 Premixed Insulin Analogs in Type 2 Diabetes: Systematic Review and Clinical Recommendations.

INTRODUCTION: Premixed insulin analogs represent an alternative to basal or basal-bolus insulin regimens for the treatment of type 2 diabetes (T2D). "Low-mix" formulations with a low rapid-acting to long-acting analog ratio (e.g., 25/75) are commonly used, but 50/50 formulations (Mix50) may be more appropriate for some patients. We conducted a systematic literature review to assess the efficacy and safety of Mix50, compared with low-mix, basal, or basal-bolus therapy, for insulin initiation and intensification. METHODS: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, ClinicalTrials.gov, LillyTrials.com, and NovoNordisk-trials.com were searched (11 or 13 Dec 2016) using terms for T2D, premixed insulin analogs, and/or Mix50. Studies (randomized, nonrandomized, or observational; English only) comparing Mix50 with other insulins (except human) and reporting key efficacy [glycated hemoglobin (HbA1c), fasting and postprandial glucose] and/or safety (hypoglycemia, weight gain) outcomes were eligible for inclusion. Narrative reviews, letters, editorials, and conference abstracts were excluded. Risk of bias in randomized trials was assessed using the Cochrane tool. RESULTS: MEDLINE and EMBASE searches identified 716 unique studies, of which 32 met inclusion criteria. An additional three studies were identified in the other databases. All 19 randomized trials except one were open label; risk of other biases was generally low. Although not conclusive, the evidence suggests that Mix50 may provide better glycemic control (HbA1c reduction) and, particularly, postprandial glucose reduction in certain patients, such as those with high carbohydrate diets and Asian patients, than low-mix and basal therapy. Based on this evidence and our experience, we provide clinical guidance on factors to consider when deciding whether Mix50 is appropriate for individual patients. CONCLUSIONS: Mix50 may be more suitable than low-mix therapy for certain patients. Clinicians should consider not only efficacy and safety but also patient characteristics and preferences when tailoring insulin treatment to individuals with T2D. FUNDING: Eli Lilly.

The Role of Gut-brain Axis in Regulating Glucose Metabolism After Acute Pancreatitis.

OBJECTIVES: Diabetes has become an epidemic in developed and developing countries alike, with an increased demand for new efficacious treatments. A large body of pre-clinical evidence suggests that the gut-brain axis may be exploited as a potential therapeutic target for defective glucose homeostasis. This clinical study aimed to investigate a comprehensive panel of glucoregulatory peptides, released by both the gut and brain, in individuals after acute pancreatitis. METHODS: Fasting levels of glucagon-like peptide-1 (GLP-1), glicentin, oxyntomodulin, peptide YY, ghrelin, cholecystokinin, vasoactive intestinal peptide (VIP), and secretin were studied. Modified Poisson and multivariable linear regression analyses were conducted. Pre-determined concentration ranges were used to categorize each peptide into quartiles. RESULTS: A total of 83 individuals were included, of who 30 (36%) developed abnormal glucose metabolism (AGM) after acute pancreatitis. In individuals with AGM, the highest quartile of oxyntomodulin differed most significantly from the lowest quartile with a prevalence ratio (PR; 95% confidence interval) of 0.50 (0.21, 1.20; P=0.005); of glicentin with a PR of 0.26 (0.13, 0.54; P<0.001); and of VIP with a PR of 0.34 (0.13, 0.89; P=0.043). Peptide YY, GLP-1, cholecystokinin, ghrelin, and secretin were not significantly associated with AGM. CONCLUSIONS: Fasting circulating oxyntomodulin, glicentin, and VIP levels are significantly decreased in patients with defective glucose homeostasis after acute pancreatitis. Oxyntomodulin appears to be a promising therapeutic target for future clinical studies on diabetes associated with diseases of the exocrine pancreas.

Costs of bariatric surgery in a randomised control trial (RCT) comparing Roux en Y gastric bypass vs sleeve gastrectomy in morbidly obese diabetic patients.

AIM: To provide a longitudinal analysis of the direct healthcare costs of providing laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery service in the context of a randomised control trial (RCT) of obese patients with type 2 diabetes in Waitemata District Health Board, Auckland, New Zealand. METHODS: The Waitemata District Health Board costing system was used to calculate costs in New Zealand Dollars (NZD) associated with all pre- and post-operative hospital clinic visits, peri-operative care, hospitalisations and medication costs up to one year after bariatric surgery. Healthcare costs of medications, laboratory investigations and hospital clinic visits for one year prior to enrolment into the RCT were also calculated. RESULTS: One hundred and fourteen patients were randomised to undergo laparoscopic sleeve gastrectomy (LSG, n=58) or laparoscopic Roux en Y gastric bypass (LRYGB, n=56). Total costs one year pre-enrolment was $203,926 for all patients (mean $1,789 per patient). Total cost of surgery was $1,208,005 (mean $9,131 per LSG patient and mean $12,456 per LRYGB patient). Total cost one year post-operatively was $542,656 (mean $4,760 per patient). The total medication cost reduced from $118,993.72(mean $1,044 per patient) to $31,304.93 (mean $274.60 per patient), p<0.005. The largest cost reduction was seen with annual diabetic medications reducing from $110,115.78(mean $965.93 per patient) to $7,237.85 (mean $63.48 per patient), p<0.005. CONCLUSIONS: Among patients with type 2 diabetes and morbid obesity undergoing LSG and LRYGB, health service costs were greater in the year after surgery than in the year before, although prescription costs were lower post-operatively. There was no significant difference in reduction in prescription cost by surgical procedure at 12 months. However, the LRYGB surgery was more expensive than LSG, primarily because of the longer operative time required.

Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol.

INTRODUCTION: Type 2 diabetes (T2D) in association with obesity is an increasing disease burden. Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c<6% (<42 mmol/mol) without the use of diabetes medication at 5 years. METHODS AND ANALYSIS: Single-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include age 20-55 years, T2D of at least 6 months duration and body mass index 35-65 kg/m(2) for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c<5.7% (39 mmol/mol) or HbA1c<6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission. ETHICS AND DISSEMINATION: Ethics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. Results will be reported in manuscripts submitted to peer-reviewed journals and in presentations at national and international meetings. TRIAL REGISTRATION NUMBERS: ACTRN12611000751976, NCT01486680; Pre-results.