Diabetes remission and relapse following an intensive metabolic intervention combining insulin glargine/lixisenatide, metformin and lifestyle approaches: Results of a randomised controlled trial.

AIM: Non-surgical options for inducing type 2 diabetes remission are limited. We examined whether remission can be achieved by combining lifestyle approaches and short-term intensive glucose-lowering therapy. METHODS: In this trial, 160 patients with type 2 diabetes on none to two diabetes medications other than insulin were randomised to (a) an intervention comprising lifestyle approaches, insulin glargine/lixisenatide and metformin, or (b) standard care. Participants with glycated haemoglobin (HbA1c) <7.3% (56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for an additional 52 weeks. The primary outcome was diabetes relapse defined as HbA1c ≥6.5% (48 mmol/mol) at 24 weeks or thereafter, capillary glucose ≥10 mmol/L on ≥50% of readings, or use of diabetes medications, analysed as time-to-event. Main secondary outcomes included complete or partial diabetes remission at 24, 36, 48 and 64 weeks defined as HbA1c <6.5% (48 mmol/mol) off diabetes medications since 12 weeks after randomisation. A hierarchical testing strategy was applied. RESULTS: The intervention significantly reduced the hazard of diabetes relapse by 43% (adjusted hazard ratio 0.57, 95% confidence interval 0.40-0.81; p = .002). Complete or partial diabetes remission was achieved in 30 (38.0%) intervention group participants versus 16 (19.8%) controls at 24 weeks and 25 (31.6%) versus 14 (17.3%) at 36 weeks [relative risk 1.92 (95% confidence interval 1.14-3.24) and 1.83 (1.03-3.26), respectively]. The relative risk of diabetes remission in the intervention versus control group was 1.88 (1.00-3.53) at 48 weeks and 2.05 (0.98-4.29) at 64 weeks. CONCLUSIONS: A 12-week intensive intervention comprising insulin glargine/lixisenatide, metformin and lifestyle approaches can induce remission of diabetes.

Relationship of parental feeding practices and diet with children's diet among South Asians in Canada.

BACKGROUND: South Asian children's diets are considered unhealthy, yet the relationship with food parenting among South Asians is understudied. METHODS: In a cross-sectional study, questionnaires were administered to dyads of Canadian South Asian elementary and high school children and a parent. Relationships between parental factors (perceived responsibility, restriction, pressure to eat, monitoring, home food environment, nutrition knowledge and intake of fruits and vegetables (FV), sugary beverages (SB) and sweets and fast foods (SWFF) and children's intake of FV, SB and SWFF were assessed by linear regression adjusted for sociodemographics. Subgroup differences by children's age and acculturation were explored by interaction analysis. RESULTS: 291 children (age 9.8 ± 3.2 years) had mean daily intake frequencies of 3.1 ± 2.0 FV, 1.0 ± 0.9 SB and 2.1 ± 1.5 SWFF. Positive associations were found between parent and child intake of FV (standardized beta (ß) = 0.230, [95%CI 0.115, 0.345], p < 0.001), SB (ß = 0.136 [0.019, 0.252], p = 0.02), and SWFF (ß = 0.167 [0.052, 0.282], p = 0.005). Parental monitoring was associated with lower children's SWFF intake (ß = -0.131 [-0.248, -0.015], p = 0.03). Among those expressing less Western culture, parental SWFF intake was associated with child's SB intake (ß = 0.255 [0.085, 0.425], p = 0.004). Among those expressing less traditional culture, positive home food environment was associated with lower child SWFF intake (ß = -0.208 [-0.374, -0.042], p = 0.015). CONCLUSION: South Asian children's diets have stronger relationships with their parents' diets than with food parenting practices or nutrition knowledge, though parental monitoring was associated with lower unhealthy food intake. However, with greater acculturation, the home food environment was more important for unhealthy food intake.

Impact of SARS-CoV-2 pandemic on the mental and physical health of children enrolled in a paediatric weight management clinic.

Background: Obesity is a global public health concern. Given the widespread disruption caused by the SARS-CoV-2 pandemic, it is important to evaluate its impact on children with chronic health conditions. This study examines the health of paediatric patients with obesity enrolled in a tertiary hospital weight management program, before and 1 year into the COVID-19 pandemic. Methods: This is a retrospective chart review of patients aged 2 to 17 years enrolled in a paediatric weight management clinic. Mental health outcomes (i.e., new referrals to psychologist, social work, eating disorder program, incidence of dysregulated eating, suicidal ideation, and/or self-harm) and physical health (anthropometric measures) were compared before and 1 year into the pandemic. Results: Among the 334 children seen in either period, there was an increase in referrals to psychologist (12.4% versus 26.5%; P=0.002) and the composite mental health outcome (17.2% versus 30.2%; P=0.005) during the pandemic compared with pre-pandemic. In a subset of children (n=30) with anthropometric measures in both periods, there was a lower rate of decline in BMIz score (-1.5 [2.00] versus -0.3 [0.73]/year; P=0.002) and an increase in adiposity (-0.8 [4.64] versus 2.7 [5.54]%/year; P=0.043) during the pandemic. Discussion: The pandemic has impacted the mental and physical health of children with obesity engaged in a weight management clinic. While our study provides evidence of a negative impact on mental health outcomes and less improvement in anthropometric measures, future research when patients return to in-person care will enable further examination of our findings with additional objective measures.

Accuracy of Screening Tests for Celiac Disease in Asymptomatic Patients With Type 1 Diabetes.

INTRODUCTION: To evaluate the diagnostic performance of celiac serologic tests in asymptomatic patients with type 1 diabetes (T1D). METHODS: Patients with T1D asymptomatic for celiac disease were prospectively screened with immunoglobulin A anti-tissue transglutaminase. Test characteristics were calculated and optimal cutoffs for a positive screen determined. RESULTS: Two thousand three hundred fifty-three patients were screened and 101 proceeded to biopsy. The positive predictive value of immunoglobulin A anti-tissue transglutaminase at the assay referenced upper limit of normal (30CU) was 85.9%, and the sensitivity and specificity were 100% and 38%, respectively. DISCUSSION: Thresholds extrapolated from the general population for the diagnostic evaluation of celiac disease are not suitable for use in asymptomatic T1D patients. Population-specific screening cutoffs are required.

Relationship between diet and acculturation among South Asian children living in Canada.

INTRODUCTION: Diet and South Asian ethnicity are both associated with early onset of cardiovascular risk factors. Among youth of South Asian origin, little is known about the role of culture in determining healthy dietary patterns. We aimed to assess dietary patterns and their relationships with acculturation to Western and traditional lifestyles among South Asian youth in Canada. METHODS: The Research in Cardiovascular Health - Lifestyles, Environments and Genetic Attributes in Children and Youth (RICH LEGACY) study targeted South Asian children and adolescents aged 7-8 and 14-15 years in two Canadian cities. In this cross-sectional study, acculturation questionnaires and food frequency questionnaires were administered to assess the correlations between Western and traditional culture scores, immigration status (generation and length of residency) in Canada and intake frequency of various foods. RESULTS: Among 759 youth, those who ate fruits and vegetables more often consumed dairy and whole grains more often (all r = 0.17-0.22, all p < 0.001), while those who ate fast food more often consumed meat, sweets and sugared drinks more often (all r 0.24-0.38, all p < 0.001). Traditional culture scores were weakly positively correlated with whole grain intake frequency (r = 0.12, p = 0.001), and negatively with meat intake frequency (r = -0.14, p < 0.001). Western culture scores positively correlated with high intake frequency of meat (r = 0.23, p < 0.001), fast food (r = 0.14, p < 0.001) and sweets (r = 0.14, p < 0.001). DISCUSSION: Children who are more acculturated with Western lifestyle consumed foods associated with increased metabolic risk. However, whether this eating pattern translates into increased risk of obesity and cardiovascular diseases needs to be further explored.

Testing an audit and feedback-based intervention to improve glycemic control after transfer to adult diabetes care: protocol for a quasi-experimental pre-post design with a control group.

BACKGROUND: When young adults transfer from pediatric to adult diabetes care they are at risk for deterioration of glycemic control, putting them at an increased risk of developing both acute and chronic complications. Despite increased awareness of these risks, there are gaps in care delivery during this vulnerable time and variability in the implementation of recommended transition practice. Audit and feedback (AF) interventions have a positive but variable effect on implementation of best practices. An expert group identified specific suggestions for optimizing the effectiveness of AF interventions. We aim to test an AF-based intervention incorporating these specific suggestions to improve transition practices and glycemic control in the first year after transfer from pediatric to adult diabetes care. METHODS: This is a pragmatic quasi-experimental study; a series of three cohort studies (pre-implementation, early-implementation, and post-implementation) to compare the baseline adjusted hemoglobin A1c (HbA1c) in the 12 months after the final pediatric visit in five pediatric diabetes centres within the Ontario Pediatric Diabetes Network in Ontario, Canada. The intervention includes three components: 1) centre-level feedback reports compiling data from chart abstraction, linked provincial administrative datasets, and patient-reported experience measures; 2) webinars for facilitated conversations/coaching about the feedback; and 3) online repository of curated transition resources for providers. The primary outcome will be analyzed using a multivariable linear regression model. We will conduct a qualitative process evaluation to understand intervention fidelity and to provide insight into the mechanisms of action of our results. DISCUSSION: There is a need to develop an innovative system-level approach to improve outcomes and the quality of care for young adults with type 1 diabetes during the vulnerable time when they transfer to adult care. Our research team, a collaboration of health services, implementation science, and quality improvement researchers, are designing, implementing, and evaluating an AF-based intervention using recommendations about how to optimize effectiveness. This knowledge will be generalizable to other care networks that aim to deliver uniformly high-quality care in diverse care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03781973. Registered 13 December 2018. Date of enrolment of the first participant to the trial: June 1, 2019.

Effects of High Density Lipoprotein Raising Therapies on Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus, with or without Renal Impairment: The Action to Control Cardiovascular Risk in Diabetes Study.

BACKGROUND: The role of high density lipoprotein-raising interventions in addition to statin therapy in patients with diabetes remains controversial. Chronic kidney disease (CKD) is a strong modifier of cardiovascular (CV) outcomes. We therefore investigated the impact of CKD status at baseline on outcomes in patients with diabetes randomized to standard statin or statin plus fenofibrate treatment in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial. METHODS: Among 5,464 participants in the ACCORD lipid trial, 3,554 (65%) were free of CKD at baseline, while 1,910 (35%) had mild to moderate CKD. Differences in CV outcomes during follow-up between CKD and non-CKD subgroups were examined. In addition, the effect of fenofibrate as compared to placebo on CV outcomes was examined for both subgroups. RESULTS: All CV outcomes were 1.4-3 times higher among patients with CKD as compared to non-CKD patients. In patients with CKD, the addition of fenofibrate had no effect on any of the primary or secondary outcomes. In patients without CKD, however, the addition of fenofibrate was associated with a significant 36% reduction of CV mortality (hazards ratio [HR] 0.64; 95% CI 0.42-0.97; p value for treatment interaction <0.05) and 44% lower rate of fatal or non-fatal congestive heart failure (CHF; HR 0.56; 95% CI 0.37-0.84; p value treatment interaction <0.03). CONCLUSIONS: For patients with type 2 diabetes at high CV risk but no CKD, fenofibrate therapy added to statin reduced the CV mortality and the rate of fatal and non-fatal CHF.

Withholding versus Continuing Angiotensin-converting Enzyme Inhibitors or Angiotensin II Receptor Blockers before Noncardiac Surgery: An Analysis of the Vascular events In noncardiac Surgery patIents cOhort evaluatioN Prospective Cohort.

BACKGROUND: The effect on cardiovascular outcomes of withholding angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers in chronic users before noncardiac surgery is unknown. METHODS: In this international prospective cohort study, the authors analyzed data from 14,687 patients (including 4,802 angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker users) at least 45 yr old who had in-patient noncardiac surgery from 2007 to 2011. Using multivariable regression models, the authors studied the relationship between withholding angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers and a primary composite outcome of all-cause death, stroke, or myocardial injury after noncardiac surgery at 30 days, with intraoperative and postoperative clinically important hypotension as secondary outcomes. RESULTS: Compared to patients who continued their angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, the 1,245 (26%) angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker users who withheld their angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers in the 24 h before surgery were less likely to suffer the primary composite outcome of all-cause death, stroke, or myocardial injury (150/1,245 [12.0%] vs. 459/3,557 [12.9%]; adjusted relative risk, 0.82; 95% CI, 0.70 to 0.96; P = 0.01) and intraoperative hypotension (adjusted relative risk, 0.80; 95% CI, 0.72 to 0.93; P < 0.001). The risk of postoperative hypotension was similar between the two groups (adjusted relative risk, 0.92; 95% CI, 0.77 to 1.10; P = 0.36). Results were consistent across the range of preoperative blood pressures. The practice of withholding angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers was only modestly correlated with patient characteristics and the type and timing of surgery. CONCLUSIONS: Withholding angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers before major noncardiac surgery was associated with a lower risk of death and postoperative vascular events. A large randomized trial is needed to confirm this finding. In the interim, clinicians should consider recommending that patients withhold angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers 24 h before surgery.

Perceptions of healthy eating amongst Indian adolescents in India and Canada.

INTRODUCTION: Dietary patterns have contributed to the rising prevalence of overweight and obesity among Indian adolescents. Yet there are limited studies on their perspectives on healthy eating. The purpose of this study was to understand perceptions and attitudes of Indian-origin adolescents in India and Canada that may contribute to healthy eating behaviour. METHODS: Qualitative data collection and analysis of 13 focus group discussions (FGD) was conducted among 34 boys and 39 girls (total number of participants: 73) of different weight and socioeconomic status (SES) in rural and urban India, and urban Canada aged 11-18 years. RESULTS: All adolescents perceived homemade foods, and foods high in vitamins, minerals and fiber as healthy. Rural Indian adolescents also identified contaminant-free food as important. Opinions differed regarding the health value of consuming meat, and amongst Canadian adolescents, the health impact of Western versus Indian diets. Identified benefits of healthy eating included improved energy for Indians, and disease prevention for Canadians and urban Indians. Identified barriers across all settings included peers; and availability, access and affordability of unhealthy foods. Urban Indians and Canadian girls also reported academic stress and lack of time as barriers. Canadian girls reported limited parental supervision during mealtimes as an additional barrier. Facilitators to healthy eating included parents, friends and personal preferences for healthy foods. CONCLUSION: This study suggests potential targets for family-based and school-based education programs and policies to improve dietary habits of Indian and Indo-Canadian adolescents which include, culturally focused nutrition education and guidelines, academic stress management strategies, parental education, food hygiene regulations and restriction on the sale and advertising of unhealthy foods.

Cardiovascular Outcomes in Action to Control Cardiovascular Risk in Diabetes: Impact of Blood Pressure Level and Presence of Kidney Disease.

BACKGROUND: Persons with chronic kidney disease (CKD) represent a population prone to cardiovascular disease (CVD) but vulnerable to adverse medication effects. We assessed the impact of intensive antihypertensive therapy on the cerebrovascular and other CVD outcomes in high-risk patients with type 2 diabetes and baseline CKD. METHODS: Using current guideline criteria, 1,726 (36.9%) of 4,678 participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) blood pressure (BP) arm had mild to moderate CKD (CKD1-3B) at baseline. Participants of this study were randomized to intensive (systolic <120 mm Hg) or standard (systolic <140 mm Hg) BP goals. Fatal and non-fatal stroke were pre-specified secondary outcomes of the ACCORD study. RESULTS: Total cerebrovascular events were significantly higher in participants with baseline CKD (0.66%/year) compared with participants free of CKD (0.28%/year). A significantly higher rate of events was observed in CKD participants. Intensive antihypertensive therapy in participants without CKD at baseline resulted in a 55% significant reduction of any stroke (hazard ratio 0.447; 95% CI 0.227-0.880) and a 50% reduction of non-fatal stroke (hazard ratio 0.498; 95% CI 0.250-0.993). In participants with CKD at baseline, the occurrence of any stroke was reduced by 38% (hazard ratio 0.623; 95% CI 0.361-1.074) and non-fatal stroke by 36% (hazard ratio 0.642; 95% CI 0.361-1.142). Test for interaction was NS between the 2 groups. Changes in other CVD outcomes did not reach statistical significance. CONCLUSIONS: These findings suggest that intensive antihypertensive therapy offers significant cerebrovascular protection in diabetic participants without CKD at baseline, but significant benefit to patients with CKD cannot be excluded.

Durable change in glycaemic control following intensive management of type 2 diabetes in the ACCORD clinical trial.

AIMS/HYPOTHESIS: We aimed to determine the persistence of glycaemic control 1 year after a limited period of intensive glycaemic management of type 2 diabetes. METHODS: 4119 ACCORD Trial participants randomised to target HbA1c <6.0% (42 mmol/mol) for 4.0 ± 1.2 years were systematically transitioned to target HbA1c 7.0-7.9% (53-63 mmol/mol) and followed for an additional 1.1 ± 0.2 years. Characteristics of participants with HbA1c <6.5% (48 mmol/mol) or ≥6.5% at transition were compared. Changes in BMI and glucose-lowering medications were compared between those ending with HbA1c <6.5% vs ≥6.5%. Poisson models were used to assess the independent effect of attaining HbA1c <6.5% before transition on ending with HbA1c <6.5%. RESULTS: Participants with pre-transition HbA1c <6.5% were older with shorter duration diabetes and took less insulin but more non-insulin glucose-lowering agents than those with higher HbA1c. A total of 823 participants achieved a final HbA1c <6.5%, and had greater post-transition reductions in BMI, insulin dose and secretagogue and acarbose use than those with higher HbA1c (p < 0.0001). HbA1c <6.5% at transition predicted final HbA1c <6.5% (crude RR 4.9 [95% CI 4.0, 5.9]; RR 3.9 [95% CI 3.2, 4.8] adjusted for demographics, co-interventions, pre-intervention HbA1c, BMI and glucose-lowering medication, and post-transition change in both BMI and glucose-lowering medication). Progressively lower pre-transition HbA1c levels were associated with a greater likelihood of maintaining a final HbA1c of <6.5%. Follow-up duration was not associated with post-transition rise in HbA1c. CONCLUSIONS/INTERPRETATION: Time-limited intensive glycaemic management using a combination of agents that achieves HbA1c levels below 6.5% in established diabetes is associated with glycaemic control more than 1 year after therapy is relaxed.

Impact of COVID-19 Lockdown on Occurrence of Acute Complications of Type 1 and Type 2 Diabetes and Overall Glycemic Management.

OBJECTIVES: The association of diabetes, and COVID-19 infection has been studied extensively; however, the occurrence of diabetic ketoacidosis (DKA) or hyperglycemic/hyperosmolar states (HHS) in adults during the lockdown has not been well characterized. In this study, we aimed to identify the impact of the lockdown on occurrence and severity of DKA/HHS admissions and glycemic management. METHODS: A retrospective chart review was conducted of patients admitted to Hamilton Health Sciences with a diagnosis of DKA or HHS from April to September 2019 (pre-lockdown) and from April to September 2020 (lockdown). Adult (≥18 years old) nonpregnant patients with a single admission in the study period were included for study. RESULTS: There were 229 admissions related to diabetes, with 171 admissions meeting the inclusion criteria (n=92 pre-lockdown, n=79 lockdown). In the lockdown group, 51.8% of the patients had type 2 diabetes mellitus, with 96.2% of admissions secondary to DKA. When comparing the 2 periods, the lockdown group trended toward higher rates of death (5.4% vs 10.1%, p=0.247) and euglycemic DKA (17.6% vs 24.4%, p=0.403). There were more new diagnoses of type 1 diabetes mellitus in the lockdown group compared with the pre-lockdown group (7.3% vs 16.7%, p=0.230). The average glycated hemoglobin was lower in the lockdown group compared with the pre-lockdown group (11.8% vs 10.4%, p=0.032). CONCLUSIONS: Overall, this study is among the first in Canada to assess the impact of the COVID-19 lockdown on admissions due to DKA and HHS. Although no significant differences were noted in severity of admissions, there was a trend toward more new diagnoses of type 1 diabetes mellitus presenting in DKA during the lockdown period.

An assessment of adaptation and fidelity in the implementation of an audit and feedback-based intervention to improve transition to adult type 1 diabetes care in Ontario, Canada.

BACKGROUND: The fit between an intervention and its local context may affect its implementation and effectiveness. Researchers have stated that both fidelity (the degree to which an intervention is delivered, enacted, and received as intended) and adaptation to the local context are necessary for high-quality implementation. This study describes the implementation of an audit and feedback (AF)-based intervention to improve transition to type 1 diabetes adult care, at five sites, in terms of adaptation and fidelity. METHODS: An audit and feedback (AF)-based intervention for healthcare teams to improve transition to adult care for patients with type 1 diabetes was studied at five pediatric sites. The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) was used to document the adaptations made during the study. Fidelity was determined on three different levels: delivery, enactment, and receipt. RESULTS: Fidelity of delivery, receipt, and enactment were preserved during the implementation of the intervention. Of the five sites, three changed their chosen quality improvement initiative, however, within the parameters of the study protocol; therefore, fidelity was preserved while still enabling participants to adapt accordingly. CONCLUSIONS: We describe implementing a multi-center AF-based intervention across five sites in Ontario to improve the transition from pediatric to adult diabetes care for youth with type 1 diabetes. This intervention adopted a balanced approach considering both adaptation and fidelity to foster a community of practice to facilitate implementing quality improvement initiatives for improving transition to adult diabetes care. This approach may be adapted for improving transition care for youth with other chronic conditions and to other complex AF-based interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03781973. Registered 13 December 2018. Date of enrolment of the first participant to the trial: June 1, 2019.

Characteristics of Abdominal Visceral Adipose Tissue, Metabolic Health and the Gut Microbiome in Adults.

CONTEXT: Compared with the relatively benign effects of increased subcutaneous adipose tissue (SAT), increased visceral adipose tissue (VAT) volume is a causal risk factor for hypertension, hyperlipidemia, type 2 diabetes, and cardiovascular disease. In rodents, increased VAT volume and triglyceride density and ectopic lipid accumulation in kidneys and liver have been induced by alterations in the gut microbiome. However, few studies have characterized these relationships in humans. OBJECTIVE: To evaluate the tissue triglyceride content of VAT and SAT, liver, kidneys, and pancreas in male and female adults and assess associations with markers of glucose tolerance, serum insulin, and lipids and characteristics of the gut microbiome. METHODS: Cross-sectional observational study of healthy human adults (n = 60) at a clinical research center. Body mass index (BMI), body composition, and oral glucose tolerance were assessed. Microbiome analysis was conducted on stool samples using 16S rRNA v3 amplicon sequencing. The triglyceride content of VAT, SAT, liver, kidney and pancreas were determined by assessing proton density fat fraction (PDFF) with magnetic resonance imaging (MRI). RESULTS: Higher VAT PDFF and the ratio of VAT to SAT PDFF were related to higher BMI, HbA1c, HOMA-IR, non-high-density lipoprotein cholesterol, plasma triglycerides, low-density lipoprotein (LDL) cholesterol, and lower high-density lipoprotein (HDL) cholesterol. A higher VAT PDFF and VAT to SAT PDFF ratio were associated with lower alpha diversity and altered beta diversity of the gut microbiome. Differences in VAT were associated with higher relative abundance of the phylum Firmicutes, lower relative abundance of the phylum Bacteroidetes, and enrichment of the bacterial genera Dorea, Streptococcus, and Solobacterium. CONCLUSION: VAT PDFF measured with MRI is related to impaired glucose homeostasis, dyslipidemia, and differences in the gut microbiome, independently of the total body fat percentage.

Targeting skeletal muscle health with exercise in people with type 1 diabetes: A protocol for HOMET1D, a prospective observational trial with matched controls.

INTRODUCTION: Individuals with type 1 diabetes (T1D) experience a complex set of alterations to skeletal muscle metabolic, neuromuscular, and vascular health; collectively referred to as diabetic myopathy. While the full scope of diabetic myopathy is still being elucidated, evidence suggests that even when individuals with T1D are physically active, indices of myopathy still exist. As such, there is a question if adherence to current physical activity guidelines elicits improvements in skeletal muscle health indices similarly between individuals with and without T1D. The objectives of this trial are to: 1) compare baseline differences in skeletal muscle health between adults with and without T1D, 2) examine the association between participation in a home-based exercise program, detraining, and retraining, with changes in skeletal muscle health, and 3) examine the roles of age and sex on these associations. METHODS AND ANALYSIS: This will be a prospective interventional trial. Younger (18-30 years) and older (45-65 years) males and females with T1D and matched individuals without T1D will engage in a four-phase, 18-week study sequentially consisting of a one-week lead-in period, 12-week exercise training program, one-week detraining period, and four-week retraining period. The exercise program will consist of aerobic and resistance exercise based on current guidelines set by Diabetes Canada. Metabolic, neuromuscular, and vascular outcome measures will be assessed four times: at baseline, post-exercise program, post-detraining, and post-retraining. Differences in baseline metrics between those with and without T1D will be examined with independent sample t-tests, and with two-way analyses of variance for age- and sex-stratified analyses. Changes across the duration of the study will be examined using mixed-model analyses. DISSEMINATION: Findings from this research will be shared locally and internationally with research participants, clinicians, diabetes educators, and patient advocacy organizations via in-person presentations, social media, and scientific fora. TRIAL REGISTRATION NUMBER: NCT05740514.

Setting the record straight on TIDE: a lost opportunity for patients with diabetes.

Much has been written regarding the recently discontinued Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial (ClinicalTrials.gov NCT00879970; Diabetologia 55: 36-45) and a variety of opinions have been advanced regarding its purpose, context and design (N Engl J Med 397: 959-964). As such, we deemed it appropriate to clarify TIDE's objectives, research questions and design and the clinical equipoise regarding its research questions.

Changes in trabecular bone microarchitecture in postmenopausal women with and without type 2 diabetes: a two year longitudinal study.

BACKGROUND: The risk of experiencing an osteoporotic fracture is greater for adults with type 2 diabetes despite higher than normal bone mineral density (BMD). In addition to BMD, trabecular bone microarchitecture contributes to bone strength, but is not assessed using conventional BMD measurement by dual x-ray absorptiometry (DXA). The aim of this study was to compare two year changes in trabecular bone microarchitecture in women with and without type 2 diabetes. METHODS: We used a 1 Tesla magnetic resonance imaging (MRI) scanner to acquire axial images (resolution 195 µm × 195 µm × 1000 µm) of the distal radius. We report the change in the number and size of trabecular bone holes, bone volume fraction (BVTV), trabecular thickness (Tb.Th), number (Tb.N) and separation (Tb.Sp), endosteal area, nodal and branch density for each group. Lumbar spine and proximal femur BMD were measured with DXA (Hologic, Discovery QDR4500A) at baseline and follow-up. Using a multivariable linear regression model, we evaluated whether the percent change in the trabecular bone microarchitecture variables differed between women with and without type 2 diabetes. RESULTS: Of the 54 participants at baseline with valid MRI image sets, 37 participants (baseline mean [SD] age, 70.8 [4.4] years) returned for follow-up assessment after 25.4 [1.9] months. Lumbar spine BMD was greater for women with diabetes compared to without diabetes at both baseline and follow-up. After adjustment for ethnicity, women with diabetes had a higher percent increase in number of trabecular bone holes compared to controls (10[1] % versus -7 [2]%, p=0.010), however results were no longer significant after adjustment for multiple comparisons (p=0.090). There were no differences in the change in other trabecular bone microarchitecture variables between groups. CONCLUSION: There were no differences in percent change in trabecular bone microarchitecture variables over two years in women with type 2 diabetes compared to women without diabetes. This study provides feasibility data, which will inform future trials assessing change in trabecular bone microarchitecture in women with type 2 diabetes. Larger studies using higher resolution imaging modalities that can assess change in trabecular and cortical bone compartments in women with type 2 diabetes are needed.

The association of maternal sugary beverage consumption during pregnancy and the early years with childhood sugary beverage consumption.

OBJECTIVES: A woman's food choices during pregnancy may be associated with her offspring's food choices. Several studies support an association between childhood sugary beverage (SB) consumption and poor cardiometabolic health. This study aimed to assess the association of maternal SB consumption during pregnancy and later, with her offspring's SB consumption in early infancy and childhood. METHODS: A total of 1945 women and 1595 children participating in 3 Canadian studies reported SB consumption during pregnancy, at 2 years of age, and/or at school age (5 to 8 years old). Mother and offspring SB intakes were self-reported by mothers. Multivariable linear regression analyses were conducted within each cohort and cohort data were combined using fixed effect meta-analyses. RESULTS: Maternal SB consumption during pregnancy was associated with higher offspring SB consumption at 2 years of age (standardized ß = 0.19 predicted change in the number of standard deviations of offspring SB intake for an increase of 1 standard deviation in maternal serving [95% CI: 0.16 to 0.22]). Concurrent maternal SB consumption was associated with higher offspring SB intake when children were aged 5 to 8 years (standardized ß= 0.25 [95% CI: 0.10 to 0.40]). CONCLUSION: Maternal SB consumption during pregnancy is associated with a marginally higher SB intake among their offspring at age 2, and concurrent maternal consumption is associated with a higher SB intake among school-aged offspring (5 to 8 years old). Future interventions tailored for pregnancy and early childrearing years to reduce SB intakes of mothers may reduce young children's SB intake.

RéSUMé: OBJECTIFS: Il peut y avoir un lien entre les choix alimentaires d'une femme pendant la grossesse et ceux de son enfant. Plusieurs études font état d'une association entre la consommation de boissons sucrées (BS) durant l'enfance et la mauvaise santé cardiométabolique. Notre étude visait à évaluer l'association entre la consommation de BS des mères pendant et après la grossesse et la consommation de BS de leurs enfants durant la petite enfance et l'enfance. MéTHODE: En tout, 1 945 femmes et 1 595 enfants participant à 3 études canadiennes ont fait état de leur consommation de BS pendant la grossesse, à l'âge de 2 ans et/ou à l'âge scolaire (5 à 8 ans). La consommation de BS des mères et des enfants a été déclarée par les mères. Des analyses de régression linéaire multivariée ont été menées dans chaque cohorte, et les données des cohortes ont été combinées à l'aide de méta-analyses à effets fixes. RéSULTATS: La consommation maternelle de BS pendant la grossesse était associée à une consommation de BS plus élevée chez les enfants à l'âge de 2 ans (le coefficient ß standardisé = 0,19 prédisait le changement du nombre d'écart-types de consommation de BS chez les enfants pour chaque hausse de 1 écart-type de la portion maternelle [IC de 95 % : 0,16 à 0,22]). La consommation maternelle concomitante de BS était associée à une consommation de BS plus élevée chez les enfants lorsqu'ils étaient âgés de 5 à 8 ans (coefficient ß standardisé = 0,25 [IC de 95 % : 0,10 à 0,40]). CONCLUSION: La consommation maternelle de BS pendant la grossesse est associée à une consommation de BS marginalement plus élevée chez l'enfant à l'âge de 2 ans, et la consommation maternelle concomitante est associée à une consommation de BS plus élevée chez l'enfant d'âge scolaire (5 à 8 ans). De futures interventions visant à réduire la consommation de BS des mères pendant la grossesse et durant les premières années où elles élèvent leurs enfants pourraient réduire la consommation de BS des jeunes enfants.