A Behavioral Lifestyle Intervention Enhanced With Multiple-Behavior Self-Monitoring Using Mobile and Connected Tools for Underserved Individuals With Type 2 Diabetes and Comorbid Overweight or Obesity: Pilot Comparative Effectiveness Trial.

BACKGROUND: Self-monitoring is a cornerstone of behavioral lifestyle interventions for obesity and type 2 diabetes mellitus. Mobile technology has the potential to improve adherence to self-monitoring and patient outcomes. However, no study has tested the use of a smartphone to facilitate self-monitoring in overweight or obese adults with type 2 diabetes mellitus living in the underserved community. OBJECTIVE: The aim of this study was to examine the feasibility of and compare preliminary efficacy of a behavioral lifestyle intervention using smartphone- or paper-based self-monitoring of multiple behaviors on weight loss and glycemic control in a sample of overweight or obese adults with type 2 diabetes mellitus living in underserved communities. METHODS: We conducted a randomized controlled trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention. Overweight or obese patients with type 2 diabetes mellitus were recruited from an underserved minority community health center in Houston, Texas. They were randomly assigned to one of the three groups: (1) behavior intervention with smartphone-based self-monitoring, (2) behavior intervention with paper diary-based self-monitoring, and (3) usual care group. Both the mobile and paper groups received a total of 11 face-to-face group sessions in a 6-month intervention. The mobile group received an Android-based smartphone with 2 apps loaded to help them record their diet, physical activity, weight, and blood glucose, along with a connected glucometer, whereas the paper group used paper diaries for these recordings. Primary outcomes of the study included percentage weight loss and glycated hemoglobin (HbA1c) changes over 6 months. RESULTS: A total of 26 patients were enrolled: 11 in the mobile group, 9 in the paper group, and 6 in the control group. We had 92% (24/26) retention rate at 6 months. The sample is predominantly African Americans with an average age of 56.4 years and body mass index of 38.1. Participants lost an average of 2.73% (mobile group) and 0.13% (paper group) weight at 6 months, whereas the control group had an average 0.49% weight gain. Their HbA1c changed from 8% to 7 % in mobile group, 10% to 9% in paper group, and maintained at 9% for the control group. We found a significant difference on HbA1c at 6 months among the 3 groups (P=.01). We did not find statistical group significance on percentage weight loss (P=.20) and HbA1c changes (P=.44) overtime; however, we found a large effect size of 0.40 for weight loss and a medium effect size of 0.28 for glycemic control. CONCLUSIONS: Delivering a simplified behavioral lifestyle intervention using mobile health-based self-monitoring in an underserved community is feasible and acceptable and shows higher preliminary efficacy, as compared with paper-based self-monitoring. A full-scale randomized controlled trial is needed to confirm the findings in this pilot study. TRIAL REGISTRATION: ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648 (Archived by WebCite at http://www.webcitation.org/6ySidjmT7).

Lumbar Spine Trabecular Bone Score (TBS) Reflects Diminished Bone Quality in Patients With Diabetes Mellitus and Oral Glucocorticoid Therapy.

Trabecular bone score (TBS) is a texture parameter that measures the grayscale variation within dual-energy X-ray absorptiometry (DXA) images, and has been shown to significantly correlate with the 3-dimensional bone microarchitecture. The objective of this study was to determine whether TBS is a better clinical tool than traditionally used bone mineral density (BMD) to detect the skeletal deterioration seen in patients with diabetes (DM), patients undergoing oral glucocorticoid (GC) therapy, and patients who are both diabetic and taking steroids (GC + DM). We performed retrospective, cross-sectional study using DXA images of patients who visited UTHealth Department of Internal Medicine DXA clinic in Houston, TX, from May 30, 2014 to May 30, 2016. A total of 477 men and women, who were 55 years or older, were included in the study. Lumbar spine (LS) BMD and TBS were collected. Electronic medical records were reviewed to collect clinical information for each patient. When both men and women were analyzed as a single group, LS-BMD was significantly higher in the diabetic group than in the control group (1.14 vs 1.10, p = 0.038), whereas mean TBS of L1-L4 was significantly lower in the diabetic group (1.21 vs 1.26, p = 0.004). LS-TBS was also significantly lower in diabetic women than in nondiabetic women (1.20 vs 1.26, p = 0.002). Receiver operating characteristic curves and areas under the curve indicated that LS-TBS provided better ability than LS-BMD to discriminate between control subjects and those in the DM, GC, or GC + DM groups (areas under the curve between 0.645 and 0.697, p < 0.010 for all). LS-TBS is a BMD-independent parameter that is capable of capturing a larger portion of bone quality deterioration undetected by BMD alone in patients with DM and undergoing oral GC therapy.

Finding a Path to Entrustment in Undergraduate Medical Education: A Progress Report From the AAMC Core Entrustable Professional Activities for Entering Residency Entrustment Concept Group.

PROBLEM: To better prepare graduating medical students to transition to the professional responsibilities of residency, 10 medical schools are participating in an Association of American Medical Colleges pilot to evaluate the feasibility of explicitly teaching and assessing 13 Core Entrustable Professional Activities for Entering Residency. The authors focused on operationalizing the concept of entrustment as part of this process. APPROACH: Starting in 2014, the Entrustment Concept Group, with representatives from each of the pilot schools, guided the development of the structures and processes necessary for formal entrustment decisions associated with students' increased responsibilities at the start of residency. OUTCOMES: Guiding principles developed by the group recommend that formal, summative entrustment decisions in undergraduate medical education be made by a trained group, be based on longitudinal performance assessments from multiple assessors, and incorporate day-to-day entrustment judgments by workplace supervisors. Key to entrustment decisions is evidence that students know their limits (discernment), can be relied on to follow through (conscientiousness), and are forthcoming despite potential personal costs (truthfulness), in addition to having the requisite knowledge and skills. The group constructed a developmental framework for discernment, conscientiousness, and truthfulness to pilot a model for transparent entrustment decision making. NEXT STEPS: The pilot schools are studying a number of questions regarding the pathways to and decisions about entrustment. This work seeks to inform meaningful culture change in undergraduate medical education through a shared understanding of the assessment of trust and a shared trust in that assessment.

A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

OBJECTIVES: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. METHODS: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter-spouse, relative, friend-who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter's glycosylated hemoglobin (A1C) data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. RESULTS: Fewer individuals in the intervention group (n = 9) converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16). We found a statistically significant difference (p = .021) at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%). Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. DISCUSSION: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

A rare case of renal vein thrombosis due to urinary obstruction.

Renal vein thrombosis (RVT) is an uncommon condition in adults and may be caused by endothelial damage, stasis, or hypercoagulable states. RVT is commonly identified in patients with nephrotic syndrome or malignancy. We present the case of a 57-yearold man with no past medical history who presented with a 1-month history of abdominal pain, dysuria, and hematuria. Initial laboratory studies were consistent with acute kidney injury (AKI). Imaging revealed bladder distension, enlargement of the prostate, bilateral hydronephrosis, and left renal vein thrombosis extending into the inferior vena cava. His renal failure and presenting symptoms resolved with placement of a Foley catheter and ureteral stent. The patient was discharged on anticoagulation. Here, we report a rare case of RVT that appears to have occurred as a consequence of obstructive uropathy causing massive bladder distention resulting in compression of the renal vein.

The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial.

IMPORTANCE: Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. OBJECTIVE: To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA1c) in persons with type 2 diabetes and moderate to advanced chronic periodontitis. DESIGN, SETTING, AND PARTICIPANTS: The Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers. INTERVENTIONS: The treatment group (n = 257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n = 257) received no treatment for 6 months. MAIN OUTCOMES AND MEASURES: Difference in change in HbA1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. RESULTS: Enrollment was stopped early because of futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, -0.05% [95% CI, -0.23% to 0.12%]; P = .55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index (P < .001 for all). CONCLUSIONS AND RELEVANCE: Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00997178.

The effect of intranasal fluticasone propionate irrigations on salivary cortisol, intraocular pressure, and posterior subcapsular cataracts in postsurgical chronic rhinosinusitis patients.

BACKGROUND: Intranasal corticosteroid irrigations, especially budesonide, are used increasingly in the management of chronic rhinosinusitis. In post-endoscopic sinus surgery patients, irrigations may offer improved delivery at higher doses to the paranasal sinuses than intranasal spray preparations. Fluticasone propionate may have higher potency and lower systemic bioavailability than budesonide, but there is little data on its effects as an intranasal irrigation on the hypothalamic-pituitary-adrenal axis or on ocular findings. METHODS: Adult patients who had previously undergone bilateral endoscopic sinus surgery and had not taken systemic corticosteroids in the last 6 months were prospectively enrolled. Subjects irrigated with 3 mg of fluticasone propionate in 240 mL saline solution twice daily. Salivary cortisol, intraocular pressure, and the presence of posterior subcapsular cataracts were measured before drug administration and after 6 weeks of continuous use. RESULTS: Twenty-three subjects completed the study. No subjects had salivary cortisol levels below the normal range before or after therapy, and there was no statistical difference in mean salivary cortisol levels pretreatment and posttreatment (0.294 vs 0.392 µg/dL; p = 0.27). There was no clinical or statistical difference in mean intraocular pressure before or after therapy (13.3 vs 13.3 mmHg; p = 0.86). No subjects developed a posterior subcapsular cataract. CONCLUSION: Fluticasone propionate irrigations did not suppress salivary cortisol levels or result in ocular changes. Irrigation with fluticasone propionate 3 mg in 240 mL saline twice daily may be a safe alternative to other intranasal or systemic corticosteroid treatments for chronic rhinosinusitis patients.

Diabetes self-management and leptin in Mexican Americans with type 2 diabetes: the Starr County border health initiative.

PURPOSE: The purpose of the study was to (1) characterize leptin in Mexican Americans with poorly controlled type 2 diabetes, (2) examine relationships among leptin and indicators of diabetes status (body mass index and A1C), and (3) explore the effects of a culturally tailored diabetes self-management education intervention on leptin. METHODS: In Starr County, an impoverished Texas-Mexico border community, 252 Mexican Americans with type 2 diabetes were recruited to test a diabetes self-management education intervention culturally tailored in terms of language, dietary recommendations, social emphasis, family participation, and incorporation of cultural health beliefs. Groups of 8 participants were randomized to experimental or wait-listed control conditions. Outcomes were measured at 3, 6, and 12 months; by 12 months, 109 had complete leptin data. RESULTS: Most participants were women and, on average, 55 years of age, diagnosed with diabetes for 8 years, obese, and in poor glycemic control. Three variables-body mass index, sex, A1C-explained 36% of the variance in baseline leptin; there were no intervention effects on leptin. Sex, time, and gender × time interaction effects on leptin were statistically significant; greater increases in leptin over time occurred in women compared to men. In women, fasting blood glucose changes from baseline to 12 months significantly predicted leptin changes from baseline to 12 months; in men, body mass index changes predicted leptin change. CONCLUSIONS: With increasing obesity rates, further research is warranted to determine if leptin is a useful intervention target in type 2 diabetes.

Salivary cortisol can replace free serum cortisol measurements in patients with septic shock.

BACKGROUND: There is a renewed interest in adrenal function during severe sepsis. Most studies have used total serum cortisol levels; however, only free serum cortisol is biologically active. The aim of this study was to determine the validity of salivary cortisol levels as a surrogate for free serum cortisol levels during septic shock. METHODS: Fifty-seven patients with septic shock were studied to determine the correlation between total serum cortisol and salivary cortisol to free serum cortisol levels. Thirty-eight patients were included in the salivary to free serum cortisol correlation. Salivary cortisol level was tested by enzyme immunoassay. Serum total cortisol, free cortisol, and cortisol-binding globulin (CBG) levels were determined by liquid chromatography-mass spectrometry, equilibrium analysis, and radioimmunoassay, respectively. RESULTS: The mean ± SD age was 56.6 ± 18.5 years. Fifty-seven percent were women. APACHE (Acute Physiology and Chronic Health Evaluation) II score median was 26, Simplified Acute Physiology Score II median was 61, and Sequential Organ Failure Assessment median was 13. The correlation between salivary and free serum cortisol levels was 0.79 (95% CI, 0.63-0.89; P < .0001). The correlation between free serum cortisol and total serum cortisol levels was 0.86 (95% CI, 0.78-0.92; P < .0001). The mean ± SD free serum cortisol level was 2.27 ± 1.64 µg/dL. The mean ± SD salivary cortisol level was 2.60 ± 2.69 µg/dL. The mean ± SD total serum cortisol level was 21.56 ± 8.71 µg/dL. The mean ± SD CBG level was 23.54 ± 8.33 mg/dL. CONCLUSIONS: Salivary cortisol level can be used as a surrogate of free serum cortisol level in patients with septic shock with very good correlation. Salivary cortisol testing is noninvasive, easy to perform, and can be conducted daily.

Effect of ingested interferon-alpha on beta-cell function in children with new-onset type 1 diabetes.

OBJECTIVE: To evaluate the safety and efficacy of ingested human recombinant interferon-alpha (hrIFN-alpha) for preservation of beta-cell function in young patients with recent-onset type 1 diabetes. RESEARCH DESIGN AND METHODS: Subjects aged 3-25 years in whom type 1 diabetes was diagnosed within 6 weeks of enrollment were randomly assigned to receive ingested hrIFN-alpha at 5,000 or 30,000 units or placebo once daily for 1 year. The primary outcome was change in C-peptide secretion after a mixed meal. RESULTS: Individuals in the placebo group (n = 30) lost 56 +/- 29% of their C-peptide secretion from 0 to 12 months, expressed as area under the curve (AUC) in response to a mixed meal. In contrast, children treated with hrIFN-alpha lost 29 +/- 54 and 48 +/- 35% (for 5,000 [n = 27] and 30,000 units [n = 31], respectively, P = 0.028, ANOVA adjusted for age, baseline C-peptide AUC, and study site). Bonferroni post hoc analyses for placebo versus 5,000 units and placebo versus 30,000 units demonstrated that the overall trend was determined by the 5,000-unit treatment group. Adverse events occurred at similar rates in all treatment groups. CONCLUSIONS: Ingested hrIFN-alpha was safe at the doses used. Patients in the 5,000-unit hrIFN-alpha treatment group maintained more beta-cell function 1 year after study enrollment than individuals in the placebo group, whereas this effect was not observed in patients who received 30,000 units hrIFN-alpha. Further studies of low-dose ingested hrIFN-alpha in new-onset type 1 diabetes are needed to confirm this effect.

Bilateral adrenal hemorrhage: an overlooked cause of hypotension.

Bilateral adrenal hemorrhage resulting in acute adrenal insufficiency is a rare complication of anticoagulant therapy. We present the case of a patient who came to the Emergency Department with unsuspected adrenal insufficiency, followed by a second visit within 1 month with shock, to demonstrate the importance of early detection and treatment.

Milk-alkali syndrome is a major cause of hypercalcaemia among non-end-stage renal disease (non-ESRD) inpatients.

OBJECTIVE: Milk-alkali syndrome, once a common cause of hypercalcaemia, is now considered rare. Our aim was to estimate the prevalence of milk-alkali syndrome among hypercalcaemic, non-end-stage renal disease (non-ESRD) inpatients of a University Hospital and identify patients' and syndrome characteristics. DESIGN AND PATIENTS: In this retrospective chart review study, we identified patients hospitalized with possible hypercalcaemia between November 1998 and October 2003 by a computer search of admission, discharge and consultation diagnoses. Patients with renal transplantation, stage 5 chronic kidney disease (CKD-5) and those admitted for parathyroidectomy were excluded. The remaining patients' charts were reviewed for confirmation of hypercalcaemia and identification of the cause. In patients with milk-alkali syndrome, additional historical, clinical, laboratory and imaging data were collected. RESULTS: We identified 125 patients with hypercalcaemia, 11 (8.8%) of whom had milk-alkali syndrome, 42 (33.6%) had malignancy and 37 (29.6%) hyperparathyroidism. Thirty-five patients had severe hypercalcaemia, defined as corrected serum calcium 3.5 mmol/l. Malignancy accounted for 13 of those patients (37.1%) and milk-alkali for nine (25.7%). Conditions prevalent among the milk-alkali inpatients were female gender, hypertension, chronic kidney disease, osteoporosis, upper gastrointestinal diseases, diuretic treatment and vitamin D derivative supplementation. Five of the patients with milk-alkali syndrome were treated with bisphosphonates and all five developed hypocalcaemia, compared to one of the five who received conventional treatment (P = 0.047). CONCLUSION: Milk-alkali was the third leading cause of hypercalcaemia of any degree and the second cause of severe hypercalcaemia among inpatients without ESRD. In milk-alkali syndrome, treatment with bisphosphonates contributes to post-treatment hypocalcaemia.

Calcium carbonate toxicity: the updated milk-alkali syndrome; report of 3 cases and review of the literature.

OBJECTIVE: To describe 3 patients with calcium carbonate-induced hypercalcemia and gain insights into the cause and management of the milk-alkali syndrome. METHODS: We report the clinical and laboratory data in 3 patients who presented with severe hypercalcemia (corrected serum calcium > or = 14 mg/dL) and review the pertinent literature on milk-alkali syndrome. RESULTS: The 3 patients had acute renal insufficiency, relative metabolic alkalosis, and low parathyroid hormone (PTH), PTH-related peptide, and 1,25-dihydroxyvitamin D concentrations. No malignant lesion was found. Treatment included aggressive hydration and varied amounts of furosemide. The 2 patients with the higher serum calcium concentrations received pamidronate intravenously (60 and 30 mg, respectively), which caused severe hypocalcemia. Of the 3 patients, 2 were ingesting acceptable doses of elemental calcium (1 g and 2 g daily, respectively) in the form of calcium carbonate. In addition to our highlighted cases, we review the history, classification, pathophysiologic features, and treatment of milk-alkali syndrome and summarize the cases reported from early 1995 to November 2003. CONCLUSION: Milk-alkali syndrome may be a common cause of unexplained hypercalcemia and can be precipitated by small amounts of orally ingested calcium carbonate in susceptible persons. Treatment with hydration, furosemide, and discontinuation of the calcium and vitamin D source is adequate. Pamidronate treatment is associated with considerable risk for hypocalcemia, even in cases of initially severe hypercalcemia.

Characterization of an aquaporin-2 water channel gene mutation causing partial nephrogenic diabetes insipidus in a Mexican family: evidence of increased frequency of the mutation in the town of origin.

A Mexican family with partial congenital nephrogenic diabetes insipidus (NDI) that resulted from a mutation in the aquaporin-2 water channel (AQP2) was characterized, and the source of this rare mutation was traced to the family's town of origin in Mexico. Affected individuals with profound polyuria and polydipsia were homozygous for an autosomal recessive missense V168M mutation in the AQP2 gene. Expression in oocytes revealed that, although retained in the endoplasmic reticulum (ER) to a great extent, a considerable amount of the partially functional AQP2-V168M was expressed at the plasma membrane, and that its ER retention was less than AQP2-T126M, a functional mutant in severe recessive NDI. None of the affected AQP2-V168M individuals had neurologic deficits, which also suggested a milder form of the disease. The homozygous individuals reported subjective improvement in polyuria and polydipsia with the use of dDAVP (1-desamino-8-D-arginine-vasopressin). When clinically tested, infusion of dDAVP at variable doses produced a partial increase in the urinary osmolality in homozygous individuals and decreased their water intake. Heterozygotes were unaffected when compared with controls. Samples were obtained from the population of the Mexican town of origin of the family; 30% of the population was heterozygous for the V168M AQP2 mutation and 1% was homozygous for the mutation. The high frequency of this rare mutation in the town provides evidence for an important health care problem in the village with consequences for future generations.

Severe reversible dilated cardiomyopathy and hyperthyroidism: case report and review of the literature.

OBJECTIVE: To describe a case of a 46-year-old woman with Graves' disease and reversible low-output congestive heart failure and present a comparative analysis of 23 similar cases reported in the literature. METHODS: A detailed case report is presented. In addition, a review of the pertinent literature published between 1960 and 2002 was performed to identify similar cases of dilated cardiomyopathy and thyrotoxicosis and to assess the findings in these patients. RESULTS: A 46-year-old woman without primary heart disease was admitted to the hospital with Graves' thyrotoxicosis and severe low-output congestive heart failure. Her left ventricular ejection fraction (LVEF) at the time of initial assessment was less than 20%, and her condition was categorized as New York Heart Association (NYHA) functional class III. Nineteen months after she was treated for hyperthyroidism, her LVEF was 49% and her status was NYHA class I. A severe hypotensive episode occurred when b-adrenergic blockade therapy was initiated. The group of 23 similar cases from the literature plus our currently described patient had a mean age of 45 years, a male-to-female ratio of 1:1.2, Graves' disease as the principal cause, and LVEF improvement from 29% to 58%. CONCLUSION: Dilated cardiomyopathy is an unusual manifestation of hyperthyroidism with unclear cause. Clinicians should be aware of this entity because it is treatable and hypotension can occur if b-adrenergic blockade treatment is initiated.