Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.

BACKGROUND: African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. RESEARCH DESIGN AND METHODS: This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms. RESULTS: At 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (ß = - 0.026, p = 0.003) and the comparison arm (ß = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months. CONCLUSIONS: The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months. NIH TRIAL REGISTRY NUMBER: NCT01901952.

Illness Perceptions of African-Americans with Chronic Kidney Disease.

African-Americans have the highest rates of chronic kidney disease due to type 2 diabetes (T2DM-CKD) and of progression to end-stage renal disease. The purpose of this study was to describe African-American's perceptions of T2DM-CKD: specifically, perceptions of cause, risk, severity, self-management of T2DM-CKD before and after diagnosis, and overall effect on their lives. Informed by the Common Sense Model of Illness, a cross-sectional qualitative study using purposive sampling was conducted. Findings were that participants did not take T2DM seriously until they had CKD and they also had misperceptions about the cause of T2DM. Participants believed that a family history of diabetes meant nothing could prevent a T2DM onset. In addition, participants viewed primary care providers as not explicitly informing them of their status/risks regarding CKD. The study results identified factors among African-Americans that contribute to the T2DM-CKD progression. This may enhance primary care providers' ability to educate African-Americans, which may lead to more accurate perceptions.

Tachycardia in hyperthyroidism: Not so common.

OBJECTIVE: The commonly held association of hyperthyroidism with sinus tachycardia and widened pulse pressure (PP) has not been reassessed in decades despite patients with hyperthyroidism in current practice not always present with these signs. The study objective was to assess prevalence and variability of sinus tachycardia and widened PP in present day among individuals with different degrees of hyperthyroidism. METHODS: Data was collected retrospectively from 248 adult patients in an outpatient setting with biochemical evidence of hyperthyroidism, recorded heart rate (HR) and blood pressure (BP) who were not treated with medications that can influence these parameters. RESULTS: Mean age was 42.0 ± 14.2 years with 66.9% being female. Median free thyroxine (fT4) level was 3.49 (IQR 2.42-4.58) ng/dL and thyroid stimulating hormone (TSH) 0.02 (IQR 0.01-0.03) mIU/L. Tachycardia, defined as HR >100 bpm, was present in 28.2%. In the lowest and highest fT4 quartiles, tachycardia was present in 16.4% and 38.7% respectively. Using logistic regression, tachycardia was associated with higher fT4 and diastolic BP. More lenient outcome of tachycardia with HR >90 bpm was seen in 47.2%. Widened PP, defined as >50 mmHg, was observed in 64.1% of patients and correlated with higher fT4 and BP. CONCLUSIONS: Tachycardia is not a common feature of hyperthyroidism today. The relatively infrequent finding of tachycardia in this study compared to older studies may reflect differences in the way medicine is practiced today. The increased ordering of thyroid function tests most likely unmasked cases of mild or asymptomatic thyrotoxicosis. A widened PP was a more prevalent clinical finding in this study.

Factors Associated with Diabetes Control in Predominately African American and Hispanic Population with Newly Diagnosed Type 2 Diabetes.

BACKGROUND: This study characterizes factors affecting glycemic control in a predominately African American and Hispanic population with newly diagnosed type 2 diabetes (T2DM). METHODS: Retrospective longitudinal cohort study of 1638 patients with newly diagnosed T2DM to determine factors associated with improved HbA1c (ΔHbA1c ≤ - 0.5%) and achieving target HbA1c < 7%. RESULTS: At baseline, mean age 51.7 ± 11.5 years, males 52.9%, mean BMI 33.9 ± 7.8 kg/m2, median HbA1c 9.9 (7.6-12.1)%. At study end, median follow-up duration 27 (13-54) months, median HbA1c 7.0 (6.2-8.7)%, 69.6% with improved HbA1c, 48.3% achieved target HbA1c < 7%, 88.4% monitored blood glucose, 40.1% used insulin, and 72.4% reported not missing medications. In multivariate analysis, improved HbA1c significantly correlated with glucose monitoring (OR = 2.65), higher initial HbA1c (OR = 1.85), and medication adherence (OR = 1.66) and inversely correlated with insulin use (OR = 0.38) and follow-up duration (OR = 0.99). Achieving HbA1c < 7% significantly correlated with glucose monitoring (OR = 2.14), medication adherence (OR = 1.88), more provider visits (OR = 1.04), and older age (OR = 1.03). It inversely correlated with insulin use (OR = 0.47), initial HbA1c (OR = 0.93), and follow-up duration (OR = 0.98). CONCLUSIONS: In those with newly diagnosed T2DM, achieving better glycemic control was mainly related to patient self-management behaviors and inversely related to insulin use. Emphasis on patients' diabetes education and empowerment are critical to improved glycemic control.

Hypertriglyceridemia-associated acute pancreatitis: Response to continuous insulin infusion.

OBJECTIVE: To assess the response of serum triglycerides (TG) to continuous insulin infusion (CII) in adults with hypertriglyceridemia-associated acute pancreatitis (HTGP). METHODS: Retrospective analysis of TG response to standardized CII therapy in 77 adults admitted to intensive care with TG >1000 mg/dL and HTGP. RESULTS: Participants had initial TG 3869.0 [2713.5, 5443.5] mg/dL and were 39.3 ± 9.7 years old, 66.2% males, 58.4% Hispanic, BMI 30.2 [27.0, 34.8] kg/m2, 74.0% with diabetes mellitus (DM) and 50.6% with excess alcohol use. TG-goal, defined as ≤1,000 ± 100 mg/dL, was achieved in 95%. Among the 73 TG-goal achievers (responders), 53.4% reached TG-goal in <36 hours after CII initiation (rapid responders). When compared to slow responders taking≥36 hours, rapid responders had lower initial TG (2862.0 [1965.0, 4519.0] vs 4814.5 [3368.8, 6900.0] mg/dL), BMI (29.4 [25.9, 32.8] vs 31.9 [28.2, 38.3] kg/m2), DM prevalence (56.4 vs 94.1%), and reached TG-50% (half of respective initial TG) faster (12.0 [6.0, 17.0] vs 18.5 [13.0, 32.8] hours). Those with DM (n = 57) vs non-DM (n = 20) were obese (31.4 [28.0, 35.6] vs 27.8 [23.6, 30.3] kg/m2), took longer to reach TG-final (41.0 [25.0, 60.5] vs 14.5 [12.5, 25.5] hours) and used more daily insulin (1.7 [1.3, 2.1] vs 1.1 [0.5, 1.9] U/kg/day). Among those with DM, the rapid responders had higher daily use of insulin vs slow responders 1.9 [1.4, 2.3] vs 1.6 [1.1, 1.8] U/kg/day. All results significant. In multivariable analysis, predictors of faster TG response were absence of DM, lower BMI and initial TG. CONCLUSION: CII was effective in reaching TG-goal in 95% of patients with HTGP. Half achieved TG-goal within 36 hours. Presence of DM, higher BMI and initial TG slowed the time to reach TG-goal. These baseline parameters and rate of decline to TG-50% may be real-time indicators to initiate and adjust the CII for quicker response.

Insulin management in hospitalized patients with diabetes mellitus on high-dose glucocorticoids: Management of steroid-exacerbated hyperglycemia.

BACKGROUND: Glucocorticoid (GC)-exacerbated hyperglycemia is prevalent in hospitalized patients with diabetes mellitus (DM) but evidence-based insulin guidelines in inpatient settings are lacking. METHODS AND FINDINGS: Retrospective cohort study with capillary blood glucose (CBG) readings and insulin use, dosed with 50% basal (glargine)-50% bolus (lispro) insulin, analyzed in hospitalized patients with insulin-treated DM given GC and matched controls without GC (n = 131 pairs). GC group (median daily prednisone-equivalent dose: 53.36 mg (IQR 30.00, 80.04)) had greatest CBG differences compared to controls at dinner (254±69 vs. 184±63 mg/dL, P<0.001) and bedtime (260±72 vs. 182±55 mg/dL, P<0.001). In GC group, dinner CBG was 30% higher than lunch (254±69 vs. 199±77 mg/dL, P<0.001) when similar lispro to controls given at lunch. Bedtime CBG not different from dinner when 20% more lispro given at dinner (0.12 units/kg (IQR 0.08, 0.17) vs. 0.10 units/kg (0.06, 0.14), P<0.01). Despite receiving more lispro, bedtime hypoglycemic events were lower in GC group (0.0% vs. 5.9%, P = 0.03). CONCLUSIONS: Since equal bolus doses inadequately treat large dinner and bedtime GC-exacerbated glycemic excursions, initiating higher bolus insulin at lunch and dinner with additional enhanced GC-specific insulin supplemental scale may be needed as initial insulin doses in setting of high-dose GC.

Effect of short-term prednisone on beta-cell function in subjects with type 2 diabetes mellitus and healthy subjects.

OBJECTIVE: For those with type 2 diabetes mellitus (T2DM), impact of short-term high-dose glucocorticoid exposure on beta-cell function is unknown. This study aims to compare the impact on beta-cell function and insulin resistance of prednisone 40 mg between adults with newly diagnosed T2DM and healthy adults. METHODS: Five adults with T2DM and five healthy adults, all between 18-50 years, were enrolled. T2DM diagnosis was less than one year prior, HbA1c<75 mmol/mol (9.0%), with metformin treatment only. Pre- and post-therapy testing included 75-g oral glucose tolerance, plasma glucose, C-peptide, and insulin. Intervention therapy was prednisone 40mg daily for 3 days. RESULTS: Upon therapy completion, HOMA-IR did not increase or differ between groups. Percentile difference for HOMA-%B and insulinogenic index in those with T2DM was significantly lower statistically (50.4% and 69.2% respectively) compared to healthy subjects (19% and 32.2%). CONCLUSIONS: Contrary to the assumption that insulin resistance is the main driver of glucocorticoid-induced hyperglycemia, results indicate that decreased beta-cell insulin secretion is the more likely cause in those with T2DM. This is evidenced by significant drops in C-peptide AUC and HOMA-%B and increased glucose AUC in T2DM group only. These results may be caused by increased beta-cell fragility along with reduced recovery ability after glucocorticoid exposure. ClinicalTrials.gov NCT03661684.

Legacy effect in combined diabetic-renal multifactorial intervention in patients with advanced diabetic nephropathy.

AIM: Evaluate legacy effect on renal outcomes after the end of a multifactorial-multidisciplinary intervention in patients with advanced diabetic nephropathy (ADN trial) CKD 3-4. METHODS: A retrospective electronic review was conducted of 72 patients who completed the ADN trial ESRD-free with subsequent follow-up of two years or until ESRD development. RESULTS: At baseline, reflecting ADN trial end, 38 post-intervention and 34 post-control patients were similar except for lower HbA1c, SBP and age in the post-intervention group. In post-trial follow-up, ESRD developed in both groups at similar rates (23 vs 20%). ESRD occurred mainly in baseline CKD 4 (75%). In CKD 3, only those in post-control developed ESRD (28.6%, p = 0.067). A significant decline in eGFR occurred within both groups. In multivariate analyses, ESRD was associated with baseline yearly eGFR decline. Greater yearly eGFR decline was associated with higher albumin/creatinine ratio at follow-up, lower age, and baseline SBP not being at target (p = 0.005, with an R2 of 0.197). CONCLUSIONS: There was no significant post-intervention effect on ESRD progression in the two groups. Minimal legacy effect was observed in less advanced nephropathy (CKD 3). These renal and risk outcomes emphasize the importance and potential benefits of continuous and long-term multifactorial care.

Newly diagnosed type 2 diabetes in an ethnic minority population: clinical presentation and comparison to other populations.

OBJECTIVE: To characterize the clinical presentation of newly diagnosed type 2 diabetes of ethnic minority adults in Chicago and compare with other populations. RESEARCH DESIGN AND METHODS: Cross-sectional study examining the data of 2280 patients newly diagnosed with type 2 diabetes treated between 2003 and 2013 in a large Chicago public healthcare system. RESULTS: Mean age of the patients was 49±11.3 years, men 54.4%, African-Americans 48.1%, Hispanics 32.5%, unemployed 69.9%, uninsured 82.2%, English-speaking 75.1%, and body mass index was 32.8±7.4 kg/m2. Microvascular complications were present in 50.1% and macrovascular complications in 13.4%. There was a presence of either macrovascular or microvascular complications correlated with older age, hypertension, dyslipidemia, inactivity, speaking English, and being insured (p<0.01). Glycosylated hemoglobin A1c (HbA1c) at presentation did not correlate with diabetes complications. In our cohort, when compared with a diverse population in the UK and insured population in the USA, HbA1c at presentation was 10.0% (86 mmol/mol), 6.6% (49 mmol/mol), and 8.2% (66 mmol/mol); nephropathy was 22.2%, 16.7%, and 5.7%; retinopathy was 10.7%, 7.9%, and 1.4%; and neuropathy was 27.7%, and 6.7% in the UK (p<0.001). There were no significant differences between groups in the prevalence of macrovascular complications. CONCLUSION: These results show the vulnerability of underserved and underinsured patients for developing diabetes complications possibly related to a delayed diagnosis.

Combined diabetes-renal multifactorial intervention in patients with advanced diabetic nephropathy: Proof-of-concept.

AIMS: To evaluate efficacy of a multifactorial-multidisciplinary approach in delaying CKD 3-4 progression to ESRD. METHODS: Two-year proof-of-concept stratified randomized control trial conducted in an outpatient clinic of a large public hospital system. This intervention, led by a team of endocrinologists, nephrologists, nurse practitioners, and registered dietitians, integrated intensive diabetes-renal care with behavioral/dietary and pharmacological interventions. 120 low-income adults with T2DM and CKD 3-4 enrolled; 58% male, 55% African American, 23% Hispanic. RESULTS: Primary outcome was progression rate from CKD 3-4 to ESRD. Fewer intervention (13%) than control (28%) developed ESRD, p<0.05. Intervention had greater albumin/creatinine ratio (ACR) decrease (62% vs. 42%, p<0.05) and A1C<7% attainment (50% vs. 30%, p<0.05) and trended toward better lipid/blood pressure control (p=NS). Significant differences between 25 ESRD and 95 ESRD-free patients were baseline eGFR (28 vs. 40ml/min/1.73m2), annual eGFR decline (15 vs. 3ml/min/year), baseline ACR (2362 vs. 1139mg/g), final ACR (2896 vs. 1201mg/g), and final A1C (6.9 vs. 7.8%). In multivariate Cox analysis, receiving the intervention reduced hazard ratio to develop ESRD (0.125, CI 0.029-0.54) as did higher baseline eGFR (0.69, CI 0.59-0.80). Greater annual eGFR decline increased hazard ratio (1.59, CI 1.34-1.87). CONCLUSIONS: The intervention delayed ESRD. Improved A1C and ACR plus not-yet-identified variables may have influenced better outcomes. Multifactorial-multidisciplinary care may serve as a CKD 3-4 treatment paradigm.

Academy of Nutrition and Dietetics: Standards of professional performance for Registered Dietitian Nutritionists (Competent, Proficient, and Expert) in Sustainable, Resilient, and Healthy Food and Water Systems.

Sustainability is the ability of a system to be maintained over the long term. Resilience is the ability of a system to withstand disturbances and continue to function in a sustainable manner. Issues of sustainability and resilience apply to all aspects of nutrition and dietetics practice, can be practiced at both the program and systems level, and are broader than any one specific practice setting or individual intervention. Given an increasing need to apply principles of sustainability and resilience to nutrition and dietetics practice, as well as growing interest among the public and by Registered Dietitian Nutritionists of health issues related to food and water systems, the Hunger and Environmental Nutrition Dietetic Practice Group, with guidance from the Academy of Nutrition and Dietetics Quality Management Committee, has developed the Standards of Professional Performance as a tool for Registered Dietitian Nutritionists working in sustainable, resilient, and healthy food and water systems to assess their current skill levels and to identify areas for further professional development in this emerging practice area. This Standards of Professional Performance document covers six standards of professional performance: quality in practice, competence and accountability, provision of services, application of research, communication and application of knowledge, and utilization and management of resources. Within each standard, specific indicators provide measurable action statements that illustrate how sustainable, resilient, and healthy food and water systems principles can be applied to practice. The indicators describe three skill levels (competent, proficient, and expert) for Registered Dietitian Nutritionists working in sustainable, resilient, and healthy food and water systems.

Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers.

The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress toward behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group.