ABSTRACT
OBJECTIVE: To assess response predictors to radioactive iodine (RAI) therapy without using thyroid uptake for dose estimate in patients pretreated with methimazole. METHODS: Retrospective analysis was performed of patients with Graves' disease treated with RAI doses determined without using uptake studies. RESULTS: In 242 patients (median age, 41.9 years; 66.1% female), initial mean free thyroxine (FT4) level was 4.7 ng/dL with an estimated thyroid size of 49.15 g. Prior to RAI therapy, average methimazole dose was 22.7 mg/day. Mean RAI dose was 737.0 ±199.4 MBq (19.9 ± 5.4 mCi). Two hundred eight patients (85.9%) responded to RAI therapy; 185 (88.9%) became hypothyroid and 23 (11.1%) became euthyroid. The majority (90.4%) responded within 6 months of therapy with a quicker response (13.9 ± 8.3 vs 17.5 ± 13.5 weeks) for those treated with doses per gram of ≥14.8 MBq (0.4 mCi). Thirty-four nonresponders had a higher initial FT4 level and larger thyroid size with a lower RAI dose per gram of thyroid tissue. In multivariate analysis, the independent response predictor to therapy was dose per gram of thyroid tissue of ≥14.8 MBq (0.4 mCi) (hazard ratio, 3.18; 95% CI, 1.1-9.7). Doses per gram of 14.8 to 18.1 MBq (0.4-0.5 mCi) achieved maximal response rate without added advantage of higher doses. Thyroid size prior to RAI therapy, FT4 levels at diagnosis, and age were inversely related to response. CONCLUSION: RAI therapy for Graves' disease without uptake studies for dose estimates is an effective treatment method. In patients pretreated with methimazole, an RAI dose per gram of thyroid tissue of ≥14.8 MBq (0.4 mCi) showed high response rate. Prospective studies are needed to confirm the viability of this simplified and cost-effective approach.
Subject(s)
Graves Disease , Thyroid Neoplasms , Humans , Female , Adult , Male , Methimazole/therapeutic use , Iodine Radioisotopes/therapeutic use , Retrospective Studies , Graves Disease/drug therapy , Graves Disease/radiotherapyABSTRACT
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.
Subject(s)
Hyperthyroidism , Thyroxine , Adult , Female , Humans , Hyperthyroidism/complications , Hyperthyroidism/epidemiology , Male , Middle Aged , Retrospective Studies , Tachycardia/complications , Tachycardia, Sinus/epidemiology , Tachycardia, Sinus/etiology , ThyrotropinABSTRACT
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.
Subject(s)
Hypertriglyceridemia , Insulin/administration & dosage , Pancreatitis , Triglycerides/blood , Adult , Female , Humans , Hypertriglyceridemia/blood , Hypertriglyceridemia/drug therapy , Hypertriglyceridemia/etiology , Male , Middle Aged , Pancreatitis/blood , Pancreatitis/complications , Pancreatitis/drug therapy , Retrospective StudiesABSTRACT
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.
Subject(s)
Blood Glucose/analysis , Diabetes Mellitus , Glucocorticoids/adverse effects , Hyperglycemia/chemically induced , Hypoglycemic Agents/adverse effects , Insulin , Aged , Chicago/epidemiology , Diabetes Mellitus/drug therapy , Diabetes Mellitus/epidemiology , Drug Administration Schedule , Female , Humans , Insulin/administration & dosage , Insulin/blood , Male , Middle Aged , Retrospective StudiesABSTRACT
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.
Subject(s)
Black or African American/psychology , Diabetes Mellitus, Type 2/ethnology , Glycemic Control/statistics & numerical data , Hispanic or Latino/psychology , Adult , Black or African American/statistics & numerical data , Blood Glucose Self-Monitoring/statistics & numerical data , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/prevention & control , Female , Glycated Hemoglobin/analysis , Hispanic or Latino/statistics & numerical data , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Longitudinal Studies , Male , Medication Adherence/ethnology , Medication Adherence/statistics & numerical data , Middle Aged , Retrospective Studies , Self-Management/psychologyABSTRACT
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.
Subject(s)
Diabetes Mellitus, Type 2/physiopathology , Insulin-Secreting Cells/drug effects , Prednisone/pharmacology , Adult , Blood Glucose/analysis , C-Peptide/blood , Case-Control Studies , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/drug therapy , Female , Humans , Insulin/blood , Insulin Resistance , Male , Metformin/therapeutic use , Middle Aged , Young AdultABSTRACT
PURPOSE: The Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) is a new patient-reported outcome (PRO) measure for patients with acromegaly receiving injectable somatostatin analogs (SSAs) to assess clinical symptoms and adverse drug reaction interference, treatment satisfaction, and convenience. We evaluated its scale structure, reliability, validity, responsiveness, and what constitutes clinically meaningful change. METHODS: Data from two longitudinal studies (N = 79 and 82) of patients receiving a stable injectable SSA dose for ≥ 6 months who completed the Acro-TSQ and other collateral measures (e.g., AcroQoL, AIS, WPAI:SHP, EQ-5D-5L) were analyzed. RESULTS: The first study demonstrated internal consistency of the Acro-TSQ. However, several items had high ceiling effects, responsiveness could not be established, and the minimally important difference (MID) was not estimable. In the second study, factor analysis revealed six scales: Symptom Interference, Treatment Convenience, Injection Site Interference, GI Interference, Treatment Satisfaction, and Emotional Reaction. Internal consistency and test-retest reliability were confirmed; most scales demonstrated significant differences in mean scores by disease severity. Correlations between Acro-TSQ scales and other collateral measures exceeded 0.30 in absolute value, confirming convergent validity. Responsiveness in Acro-TSQ scale scores reflected improved disease control. The MID was estimated for Symptom Interference (10-12 points), Treatment Convenience (9-11) and GI Interference (8-10). CONCLUSIONS: The Acro-TSQ is a brief, yet comprehensive tool to monitor important outcomes associated with injectable acromegaly SSA treatments. Its content reflects both disease and treatment burden as well as patient satisfaction, and its relevant for use in clinical studies.
Subject(s)
Acromegaly/drug therapy , Adenoma/drug therapy , Antineoplastic Agents, Hormonal/therapeutic use , Growth Hormone-Secreting Pituitary Adenoma/drug therapy , Octreotide/therapeutic use , Patient Reported Outcome Measures , Patient Satisfaction , Peptides, Cyclic/therapeutic use , Somatostatin/analogs & derivatives , Adult , Delayed-Action Preparations , Factor Analysis, Statistical , Female , Humans , Injections, Intramuscular , Injections, Subcutaneous , Male , Middle Aged , Minimal Clinically Important Difference , Netherlands , Reproducibility of Results , Somatostatin/therapeutic use , Surveys and Questionnaires , United Kingdom , United StatesABSTRACT
OBJECTIVE: Guidelines recommend withdrawing mineralocorticoid-receptor antagonists (MRAs) for 4 weeks prior to adrenal vein sampling (AVS), but this is not always feasible because of hypertension and hypokalemia. This retrospective study of primary aldosteronism (PA) patients who underwent AVS between 2008 and 2018 assessed the effect of continuing MRA on the AVS procedure. METHODS: Clinical data including antihypertensive regimen defined by the World Health Organization Daily Defined Dose (DDD) system were collected for 19 patients with adequate cannulation and lateralization during AVS. Results were compared between 5 patients who continued and 14 patients who discontinued MRA therapy (MRA and non-MRA groups). RESULTS: At diagnosis, plasma renin activity, plasma aldosterone concentration (PAC), potassium (K) doses, and DDD were not significantly different between groups. Aldosterone-renin ratio was significantly higher in the MRA group (median, 375.0; interquartile range [IQR], 224.8 to 544.3 vs. 148.7, 118.4 to 192.1; P = .034). No difference was found in lateralization index (median 48.3; IQR, 23.6 to 52.1 vs. 8.7; 4.9 to 20.2; P = .10). Contralateral suppression, defined as aldosterone-cortisol ratio of unaffected adrenal to periphery, trended lower in the MRA group (median, 0.17; IQR, 0.03 to 0.39 vs. 0.51; 0.27 to 1.1; P = .056). All five MRA patients underwent successful adrenalectomy with at least 50% reduction in DDD and PAC and normal K postoperatively. One MRA patient did not lateralize, which was confirmed on repeat AVS, after MRA withdrawal. CONCLUSION: Continuation of MRA may not interfere with AVS lateralization or affect contralateral adrenal suppression. Continuation of MRA in preparation for AVS may be considered, especially in patients with severe PA, to avoid uncontrolled hypertension and severe hypokalemia.
Subject(s)
Hyperaldosteronism , Mineralocorticoid Receptor Antagonists , Adrenal Glands , Aldosterone , Humans , Hyperaldosteronism/diagnosis , Hyperaldosteronism/drug therapy , Mineralocorticoids , Retrospective StudiesABSTRACT
PURPOSE: Somatostatin analogs (SSAs) represent a mainstay of medical treatment for acromegaly, currently available as either intramuscular or deep subcutaneous injections. Patient-reported outcomes (PROs) are increasingly common as relevant outcomes in studies of acromegaly and its treatment, but there are no validated PRO measures available that focus on the disease burden and the impact of treatment, specifically designed for use in patients with acromegaly. We sought to develop a new and unique PRO measure, the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ). METHODS: Concept elicitation (CE) interviews were conducted with acromegaly patients in the United States receiving SSA injections at a stable dose for ≥ 6 months. A questionnaire was drafted based on these interviews; combined CE and cognitive debriefing (CE/CD) interviews were then conducted to confirm the content, clarity, and relevance of the questionnaire. RESULTS: Nineteen subjects completed interviews [n = 9 CE, n = 10 CE/CD; n = 15 Lanreotide Depot/Autogel (Somatuline), n = 4 Octreotide LAR (Sandostatin LAR)]. Most subjects responded positively when asked about the effectiveness of their current treatment; however, breakthrough symptoms, injection site reactions, and side effects were commonly reported and had negative impacts on social and emotional well-being and daily activities. All 10 subjects involved in debriefing interviews found the questionnaire to be relevant, easy to complete, and found the response options to be clear. The resulting 26-item Acro-TSQ covers symptoms and symptom control, gastrointestinal side effects and their impact on daily activities, the emotional impact of treatment, convenience and ease of use, and overall satisfaction. CONCLUSIONS: The Acro-TSQ is a novel PRO, focused on both disease burden and impact of treatment; it was found to be comprehensive, clear, and relevant for patients with acromegaly receiving injectable SSA treatment.
Subject(s)
Acromegaly/drug therapy , Adult , Bromocriptine/therapeutic use , Cabergoline/therapeutic use , Female , Human Growth Hormone/analogs & derivatives , Human Growth Hormone/therapeutic use , Humans , Interviews as Topic , Male , Middle Aged , Octreotide/therapeutic use , Peptides, Cyclic/therapeutic use , Personal Satisfaction , Somatostatin/analogs & derivatives , Somatostatin/therapeutic use , Surveys and QuestionnairesABSTRACT
CONTEXT: Psychogenic adipsic hypernatremia is an exceedingly rare and life-threatening condition, occurring in those with severe psychiatric disorders. Its diagnosis requires exclusion of congenital or acquired hypothalamic pathologic entities. We present the case of a patient who experienced transient severe hypernatremia without evidence of brain pathologic features or known psychiatric disease. In our patient, the transient adipsic hypernatremia had resulted from an episode of mild depression that resolved spontaneously. CASE DESCRIPTION: A 46-year-old healthy woman who had had three recurrent admissions within 1 month had presented for evaluation of intractable nausea and vomiting with a history of a recent episode of a depressive mood change. Each admission had shown substantial hypernatremia (maximum plasma sodium, 166 mEq/L) accompanied by a strong aversion to consuming water. The findings from the diagnostic evaluation showed elevated serum osmolality and lower than expected urine osmolality (urine osmolality range, 474-501 mOsm/kg). This finding, along with an MRI scan showing the presence of a normal posterior pituitary bright spot, suggested that the osmoregulation of her thirst and arginine vasopressin (AVP) secretion were both defective during the attack. The patient was evaluated by psychiatry. Mild depression was diagnosed, and the patient started treatment with mirtazapine, which she only took for a few days. The patient's hypernatremia had completely recovered with resolution of her depression within 2 months. CONCLUSION: A mild mood disorder can cause transient dysregulation of the thirst mechanism and AVP secretion through not yet identified mechanisms.
Subject(s)
Depressive Disorder/complications , Hypernatremia/etiology , Thirst/physiology , Antidepressive Agents/therapeutic use , Depressive Disorder/drug therapy , Depressive Disorder/physiopathology , Female , Humans , Hypernatremia/diagnosis , Hypernatremia/physiopathology , Middle Aged , Mirtazapine/therapeutic use , Osmolar Concentration , Treatment OutcomeABSTRACT
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.
Subject(s)
Black or African American/psychology , Health Knowledge, Attitudes, Practice/ethnology , Renal Insufficiency, Chronic/ethnology , Cross-Sectional Studies , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/ethnology , Humans , Qualitative Research , Renal Insufficiency, Chronic/psychologyABSTRACT
Objective: We previously developed a predictive model to assess the risk of developing acute pancreatitis (AP) in patients with severe hypertriglyceridemia (HTG). In this study, we aimed to externally validate this model. Methods: The validation cohort included cross-sectional data between 2013 and 2017. Adult patients (≥18 years old) with triglyceride levels ≥1,000 mg/dL were identified. Based on our previous 4-factor predictive model (age, triglyceride [TG], excessive alcohol use, and gallstone disease), we estimated the probability of developing AP. Model performance was assessed using area under receiver operating characteristic curve (AUROC). Results: In comparison to the original cohort, patients in the validation cohort had more prevalent acute pancreatitis (16.2% versus 9.2%; P<.001) and gallstone disease (7.5% versus 2.1%; P<.001). Other characteristics were comparable and not statistically significant. The AUROCs were almost identical: 0.8337 versus 0.8336 in the validation and the original cohorts, respectively. In univariable analyses, the highest increase in odds of AP was associated with HTG, followed by gallstones, excessive alcohol use, and younger age. Conclusion: This study externally validates the 4-factor predictive model to estimate the risk of AP in adult patients with severe HTG (TG ≥1,000 mg/dL). Younger age was confirmed to place patients at high risk of AP. The clinical risk categories suggested in this study may be useful to guide treatment options. Abbreviations: AP = acute pancreatitis; ASCVD = atherosclerotic cardiovascular disease; AUROC = area under the receiver operating characteristic curve; FRAX = fracture risk assessment tool; HTG = hypertriglyceridemia; OR = odds ratio; TG = triglyceride level.
Subject(s)
Hypertriglyceridemia , Pancreatitis , Acute Disease , Cross-Sectional Studies , Humans , Risk Factors , TriglyceridesABSTRACT
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.
Subject(s)
Black or African American/ethnology , Diabetes Mellitus, Type 2/ethnology , Diabetes Mellitus, Type 2/therapy , Poverty/ethnology , Risk Reduction Behavior , Urban Population , Adult , Aged , Diabetes Mellitus, Type 2/blood , Diet, Healthy/methods , Exercise/physiology , Female , Follow-Up Studies , Health Behavior/physiology , Humans , Male , Middle Aged , Self-Management/methods , Single-Blind MethodABSTRACT
BACKGROUND: Insulin resistance contributes to the metabolic syndrome, which is associated with the development of kidney disease. However, it is unclear if insulin resistance independently contributes to an increased risk of chronic kidney disease (CKD) progression or CKD complications. Additionally, predisposing factors responsible for insulin resistance in the absence of diabetes in CKD are not well described. This study aimed to describe factors associated with insulin resistance and characterize the relationship of insulin resistance to CKD progression, cardiovascular events and death among a cohort of non-diabetics with CKD. METHODS: Data was utilized from Chronic Renal Insufficiency Cohort Study participants without diabetes (N = 1883). Linear regression was used to assess associations with insulin resistance, defined using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). The relationship of HOMA-IR, fasting glucose, hemoglobin A1c (HbA1c), and C-peptide with CKD progression, cardiovascular events, and all-cause mortality was examined with Cox proportional hazards models. RESULTS: Novel positive associations with HOMA-IR included serum albumin, uric acid, and hemoglobin A1c. After adjustment, HOMA-IR was not associated with CKD progression, cardiovascular events, or all-cause mortality. There was a notable positive association of one standard deviation increase in HbA1c with the cardiovascular endpoint (HR 1.16, 95% CI: 1.00-1.34). CONCLUSION: We describe potential determinants of HOMA-IR among a cohort of non-diabetics with mild-moderate CKD. HOMA-IR was not associated with renal or cardiovascular events, or all-cause mortality, which adds to the growing literature describing an inconsistent relationship of insulin resistance with CKD-related outcomes.
Subject(s)
Blood Glucose , Cardiovascular Diseases/epidemiology , Insulin Resistance , Kidney , Renal Insufficiency, Chronic , Blood Glucose/analysis , Blood Glucose/metabolism , Cause of Death , Cohort Studies , Disease Progression , Female , Humans , Kidney/metabolism , Kidney/physiopathology , Male , Middle Aged , Mortality , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/metabolism , Renal Insufficiency, Chronic/mortality , Renal Insufficiency, Chronic/physiopathology , Risk Factors , United States/epidemiologyABSTRACT
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.
ABSTRACT
OBJECTIVE: To investigate the prevalence and predictors of hypertriglyceridemic acute pancreatitis (HTG-AP) in a multi-ethnic minority population. METHODS: A retrospective, cross-sectional study from 2003 to 2013 of 1,157 adults with a serum triglyceride (TG) level ≥1,000 mg/dL comparing baseline characteristics and risk factors between those with and without HTG-AP. RESULTS: Mean study population age was 49.2 ± 11.5 years; 75.6% were male, 31.6% African American, 38.4% Hispanic, 22.7% Caucasian, 5.7% Asian, and 1.6% Pacific Islander. Prevalence of HTG-AP was 9.2%. Patients with HTG-AP were significantly younger (41.3 years vs. 50.0 years; P<.001) than those without HTG-AP. Excessive alcohol intake (odds ratio [OR], 3.9; 95% confidence interval [CI], 2.5 to 6.0; P<.001), gallstone disease (OR, 3.9; 95% CI, 1.4 to 10.8; P = .008), and TG >2,000 mg/dL (OR, 4.8; 95% CI, 3.1 to 7.4; P<.001) remained significant independent risk factors. TG levels for patients with HTG-AP were higher (median TG, 2,394 mg/dL; interquartile range [IQR], 1,152 to 4,339 mg/dL vs. median TG, 1,406 mg/dL; IQR, 1,180.7 to 1,876.5 mg/dL). TG levels >2,000 mg/dL were associated with higher incidence of AP (22% vs. 5%). Patients with TG levels <2,000 mg/dL and no risk factors had prevalence of 2% compared to 33.6% with one risk factor and TG >2,000 mg/dL. Patients with HTG-AP had higher incidence of diabetic ketoacidosis at admission (7.5% vs. 2.5%; P = .004). CONCLUSION: TG level ≥2,000 mg/dL is associated with higher HTG-AP prevalence in ethnic minorities. Presence of excessive alcohol intake and/or gallstones further accentuates risk. ABBREVIATIONS: AP = acute pancreatitis; CT = computed tomography; DM = diabetes mellitus; HbA1c = hemoglobin A1c; HIV = human immunodeficiency virus; HTG = hyper-triglyceridemia; HTG-AP = hypertriglyceridemic acute pancreatitis; ROC = receiver operating characteristic; TG = triglyceride.
Subject(s)
Alcohol Drinking/epidemiology , Ethnicity/statistics & numerical data , Gallstones/epidemiology , Hypertriglyceridemia/epidemiology , Minority Groups/statistics & numerical data , Pancreatitis/epidemiology , Acute Disease , Adult , Black or African American/statistics & numerical data , Age Factors , Asian/statistics & numerical data , Cross-Sectional Studies , Female , Hispanic or Latino/statistics & numerical data , Humans , Hypertriglyceridemia/blood , Hypertriglyceridemia/complications , Incidence , Male , Middle Aged , Native Hawaiian or Other Pacific Islander/statistics & numerical data , Odds Ratio , Pancreatitis/etiology , Prevalence , Retrospective Studies , Risk Factors , Severity of Illness Index , Triglycerides/blood , United States/epidemiology , White People/statistics & numerical dataABSTRACT
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%, pâ¯=â¯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 (pâ¯=â¯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.
Subject(s)
Diabetes Mellitus, Type 2/therapy , Diabetic Nephropathies/therapy , Interdisciplinary Communication , Kidney Failure, Chronic/prevention & control , Patient Care Team , Secondary Prevention/methods , Aged , Combined Modality Therapy/methods , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/pathology , Diabetic Nephropathies/diagnosis , Diabetic Nephropathies/epidemiology , Diabetic Nephropathies/pathology , Disease Progression , Female , Follow-Up Studies , Humans , Kidney Failure, Chronic/diagnosis , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/pathology , Male , Middle Aged , Patient Care Team/organization & administration , Patient Care Team/standards , Renal Insufficiency, Chronic/epidemiology , Renal Insufficiency, Chronic/pathology , Renal Insufficiency, Chronic/prevention & control , Retrospective Studies , Risk FactorsABSTRACT
African Americans experience poorer diabetes outcomes than non-Hispanic Whites. Few clinical trials of diabetes self-management interventions specifically target African Americans, perhaps due to well-documented barriers to recruitment in this population. This paper describes strategies used to successfully recruit 211 low-income African Americans from community clinics of a large, urban public hospital system to a randomized clinical trial of an 18-month diabetes self-management intervention. Diabetes-related physiological, psychosocial, and behavioral characteristics of the sample are reported. The sample was 77% female, mean age = 55, mean A1C = 8.5%, 39% low health literacy, 28.4% moderate/severe depression, and 48.3% low adherence. Participants ate a high-fat diet with low vegetable consumption. Relative to males, females had higher BMI, depression, and stress, and better glycemic control, less physical activity, and less alcohol consumption. Males consumed more daily calories, but females consumed a greater proportion of carbohydrates. Gender-specific diabetes self-management strategies may be warranted in this population.