diabetes mellitus

5-year mental health and eating pattern outcomes following bariatric surgery in adolescents: a prospective cohort study

Author/s: 
Järvholm, K, Bruze, G, Peltonen, M, Marcus, C, Flodmark, CE, Henfridsson, P, Beamish, AJ, Gronowitz, E, Dahlgren, J, Karlsson, J, Olbers, T

BACKGROUND:

Mental health problems are prevalent among adolescents with severe obesity, but long-term mental health outcomes after adolescent bariatric surgery are not well known. We aimed to assess mental health outcomes over 5 years of follow-up after Roux-en-Y gastric bypass surgery in adolescents who participated in the Adolescent Morbid Obesity Surgery (AMOS) study.

METHODS:

This was a non-randomised matched-control study in adolescents aged 13-18 years who had a BMI of 40 kg/m2 or higher, or 35 kg/m2 or higher in addition to obesity-related comorbidity; who had previously undergone failed comprehensive conservative treatment; and were of pubertal Tanner stage III or higher, with height growth velocity beyond peak. A contemporary control group, matched for BMI, age, and sex, who underwent conventional obesity treatment, was obtained from the Swedish Childhood Obesity Treatment Register. Data on dispensed psychiatric drugs and specialist treatment for mental disorders were retrieved from national registers with complete coverage. In the surgical group only, questionnaires were used to assess self-esteem (Rosenberg Self-Esteem [RSE] score), mood (Mood Adjective Checklist [MACL]), and eating patterns (Binge Eating Scale [BES] and Three-Factor Eating Questionnaire-R21 [TFEQ]). This study is registered with ClinicalTrials.gov (NCT00289705).

FINDINGS:

Between April 10, 2006, and May 20, 2009, 81 adolescents (53 [65%] female) underwent Roux-en-Y gastric bypass surgery, and 80 control participants received conventional treatment. The proportion of participants prescribed psychiatric drugs did not differ between groups in the years before study inclusion (pre-baseline; absolute risk difference 5% [95% CI -7 to 16], p=0·4263) or after intervention (10% [-6 to 24], p=0·2175). Treatment for mental and behavioural disorders did not differ between groups before baseline (2% [-10 to 14], p=0·7135); however, adolescents in the surgical group had more specialised psychiatric treatment in the 5 years after obesity treatment than did the control group (15% [1 to 28], p=0·0410). There were few patients who discontinued psychiatric treatment post-surgery (three [4%] receiving psychiatric drug treatment and six [7%] receiving specialised care for a mental disorder before surgery). In the surgical group, self-esteem (RSE score) was improved after 5 years (mixed model mean 21·6 [95% CI 19·9 to 23·4]) relative to baseline (18·9 [17·4 to 20·4], p=0·0059), but overall mood (MACL score) was not (2·8 [2·7 to 2·9] at 5 years vs 2·7 [2·6 to 2·8] at baseline, p=0·0737). Binge eating was improved at 5 years (9·3 [7·4 to 11·2]) relative to baseline (15·0 [13·5 to 16·5], p<0·0001). Relative changes in BMI were not associated with the presence or absence of binge eating at baseline.

INTERPRETATION:

Mental health problems persist in adolescents 5 years after bariatric surgery despite substantial weight loss. Although bariatric surgery can improve many aspects of health, alleviation of mental health problems should not be expected, and a multidisciplinary bariatric team should offer long-term mental health support after surgery.

FUNDING:

Swedish Research Council, VINNOVA, Västra Götalandsregionen, ALF VG-region, Region Stockholm, Swedish Child Diabetes Foundation, Swedish Heart and Lung Foundation, Tore Nilsson's Foundation, SUS Foundations and Donations, Capio Research Foundation, and Mary von Sydow's Foundation.

Vaccines for International Travel

Author/s: 
Freedman, DO, Chen, LH

The pretravel management of the international traveler should be based on risk management principles. Prevention strategies and medical interventions should be based on the itinerary, preexisting health factors, and behaviors that are unique to the traveler. A structured approach to the patient interaction provides a general framework for an efficient consultation. Vaccine-preventable diseases play an important role in travel-related illnesses, and their impact is not restricted to exotic diseases in developing countries. Therefore, an immunization encounter before travel is an ideal time to update all age-appropriate immunizations as well as providing protection against diseases that pose additional risk to travelers that may be delineated by their destinations or activities. This review focuses on indications for each travel-related vaccine together with a structured synthesis and graphics that show the geographic distribution of major travel-related diseases and highlight particularly high-risk destinations and behaviors. Dosing, route of administration, need for boosters, and possible accelerated regimens for vaccines administered prior to travel are presented. Different underlying illnesses and medications produce different levels of immunocompromise, and there is much unknown in this discipline. Recommendations regarding vaccination of immunocompromised travelers have less of an evidence base than for other categories of travelers. The review presents a structured synthesis of issues pertinent to considerations for 5 special populations of traveler: child traveler, pregnant traveler, severely immunocompromised traveler, HIV-infected traveler, and traveler with other chronic underlying disease including asplenia, diabetes, and chronic liver disease.

Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial

Author/s: 
Hermida, R.C., Crespo, J.J., Domínguez-Sardiña, M, Otero, A., Moyá, A., Ríos, M.T., Sineiro, E., Castiñeira, M.C., Callejas, P.A., Pousa, L., Salgado, J.L., Durán, C., Sánchez, J.J., Fernández, J.R., Mojón, A., Ayala, D.E., Hygia Project Investigators

AIMS:

The Hygia Chronotherapy Trial, conducted within the clinical primary care setting, was designed to test whether bedtime in comparison to usual upon awakening hypertension therapy exerts better cardiovascular disease (CVD) risk reduction.

METHODS AND RESULTS:

In this multicentre, controlled, prospective endpoint trial, 19 084 hypertensive patients (10 614 men/8470 women, 60.5 ± 13.7 years of age) were assigned (1:1) to ingest the entire daily dose of ≥1 hypertension medications at bedtime (n = 9552) or all of them upon awakening (n = 9532). At inclusion and at every scheduled clinic visit (at least annually) throughout follow-up, ambulatory blood pressure (ABP) monitoring was performed for 48 h. During the 6.3-year median patient follow-up, 1752 participants experienced the primary CVD outcome (CVD death, myocardial infarction, coronary revascularization, heart failure, or stroke). Patients of the bedtime, compared with the upon-waking, treatment-time regimen showed significantly lower hazard ratio-adjusted for significant influential characteristics of age, sex, type 2 diabetes, chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome [0.55 (95% CI 0.50-0.61), P < 0.001] and each of its single components (P < 0.001 in all cases), i.e. CVD death [0.44 (0.34-0.56)], myocardial infarction [0.66 (0.52-0.84)], coronary revascularization [0.60 (0.47-0.75)], heart failure [0.58 (0.49-0.70)], and stroke [0.51 (0.41-0.63)].

CONCLUSION:

Routine ingestion by hypertensive patients of ≥1 prescribed BP-lowering medications at bedtime, as opposed to upon waking, results in improved ABP control (significantly enhanced decrease in asleep BP and increased sleep-time relative BP decline, i.e. BP dipping) and, most importantly, markedly diminished occurrence of major CVD events.

TRIAL REGISTRATION:

ClinicalTrials.gov, number NCT00741585.

Practice Transformation Under the University of Colorado's Primary Care Redesign Model

Author/s: 
Smith, P.C., Lyon, C., English, A.F., Conry, C.

PURPOSE:

We compared the transformation experience of 2 family medicine practices that implemented the Primary Care Redesign (PCR) team-based model to improve access, quality, and experience without increasing cost. The University of Colorado's A.F. Williams Family Medicine clinic (pilot practice) implemented the model in February 2015, and a smaller, community-based practice (wave 2 practice) did so 2 years later, in February 2017.

METHODS:

The PCR model increased the ratio of medical assistants to clinicians from about 1:2 to 2.5:1 while expanding the role of the medical assistants, through enhanced rooming procedures, in-room support (eg, scribing), postclinician wrap-up, and in-basket assistance. We assessed access, clinical quality metrics, staffing costs, and clinician and staff experience and burnout for at least 7 months before and 42 months after the intervention.

RESULTS:

In the pilot practice, compared with preimplementation, there were improvements in total appointments and rates of hypertension control, colorectal cancer screening, and most diabetic quality metrics. In the wave 2 practice, total appointments increased slightly when clinicians were added pre-PCR and then increased substantially after implementation; initially variable hypertension control improved rapidly after implementation. The wave 2 practice's colorectal cancer screening improved gradually, then accelerated postimplementation, while diabetic metrics initially remained stable or declined, then improved postimplementation. New patient appointments began to increase for both practices in late 2015, but grew faster in the pilot practice under PCR. Over time, all experiential domains improved for clinicians; most remained stable for staff. Clinician burnout was reduced by at least one-half in both practices except during low staffing periods, which also adversely affected staff. After a ramp-up period, the number of staff hours per visit remained stable.

CONCLUSIONS:

The PCR model is associated with simultaneous improvements in quality, access, and clinician experience, as well as reductions in burnout, while maintaining staffing costs.

Sitting Time and Risk of Cardiovascular Disease and Diabetes: A Systematic Review and Meta-Analysis.

Author/s: 
Bailey, D.P., Hewson, D.J., Champion, R.B., Sayegh, S.M.

Whether physical activity attenuates the association of total daily sitting time with cardiovascular disease and diabetes incidence is unclear. This systematic review and meta-analysis examined the association of total daily sitting time with cardiovascular disease and diabetes with and without adjustment for physical activity.

EVIDENCE ACQUISITION:

PubMed, Web of Science, BASE, MEDLINE, Academic Search Elite, and ScienceDirect were searched for prospective studies, published between January 1, 1989, and February 15, 2019, examining the association of total daily sitting time with cardiovascular disease or diabetes outcomes. Data extraction and study quality assessments were conducted by 2 independent reviewers. Pooled hazard ratios (HRs) were calculated using a fixed-effects model. The quality assessment and meta-analysis procedures were completed in 2018.

EVIDENCE SYNTHESIS:

Nine studies with 448,285 participants were included. A higher total daily sitting time was associated with a significantly increased risk of cardiovascular disease (HR=1.29, 95% CI=1.27, 1.30, p<0.001) and diabetes (HR=1.13, 95% CI=1.04, 1.22, p<0.001) incidence when not adjusted for physical activity. The increased risk for diabetes was unaffected when adjusting for physical activity (HR=1.11, 95% CI=1.01, 1.19, p<0.001). For cardiovascular disease, the increased risk was attenuated but remained significant (HR=1.14, 95% CI=1.04, 1.23, p<0.001).

CONCLUSIONS:

Higher levels of total daily sitting time are associated with an increased risk of cardiovascular disease and diabetes, independent of physical activity. Reductions in total daily sitting may be recommended in public health guidelines.

Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers

Author/s: 
American Diabetes Association

The American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes is updated and published annually in a supplement to the January issue of Diabetes Care. The ADA’s Professional Practice Committee, which includes physicians, diabetes educators, registered dietitians (RDs), and public health experts, develops the Standards. The Standards include the most current evidence-based recommendations for diagnosing and treating adults and children with all forms of diabetes. ADA’s grading system uses ABC, or E to show the evidence level that supports each recommendation.

  • A—Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered

  • B—Supportive evidence from well-conducted cohort studies

  • C—Supportive evidence from poorly controlled or uncontrolled studies

  • E—Expert consensus or clinical experience

This is an abridged version of the 2019 Standards containing the evidence-based recommendations most pertinent to primary care. The tables and figures have been renumbered from the original document to match this version. The complete 2019 Standards of Care document, including all supporting references, is available at professional.diabetes.org/standards.

Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a disorder characterized by hyperandrogenism, ovulatory dysfunction, and
polycystic ovaries. Its etiology remains unknown, and treatment is largely symptom based and empirical. PCOS has the
potential to cause substantial metabolic sequelae, including an increased risk of diabetes and cardiovascular disease,
and these factors should be considered when determining long-term treatment. The purpose of this document is to
examine the best available evidence for the diagnosis and clinical management of PCOS.

Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

Author/s: 
Perkovic, Vlado, Jardine, Meg J., Neal, Bruce, Bompoint, Severine, Heerspink, Hiddo J. L., Charytan, David M., Edwards, Robert, Agarwal, Rajiv, Bakris, George, Bull, Scott, Cannon, Christopher P., Capuano, George, Chu, Pei-Ling, de Zeeuw, Dick, Greene, Tom, Levin, Adeera, Pollock, Carol, Wheeler, David C., Yavin, Yshai, Zhang, Hong, Zinman, Bernard, Meininger, Gary, Brenner, Barry M., Mahaffey, Kenneth W.

BACKGROUND

Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes.

METHODS

In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically.

RESULTS

The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture.

CONCLUSIONS

In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years. (Funded by Janssen Research and Development; CREDENCE ClinicalTrials.gov number, NCT02065791.)

A Randomized Trial of Intensive versus Standard Blood-Pressure Control

Author/s: 
The SPRINT Research Group

BACKGROUND

The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain.

METHODS

We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.

RESULTS

At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group.

CONCLUSIONS

Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01206062.)

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