ResearchPad - Advanced and Specialised Nursing https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Role of Blood Lipids in the Development of Ischemic Stroke and its Subtypes]]> https://www.researchpad.co/product?articleinfo=5bfde5d7d5eed0c4846e1e7a

Supplemental Digital Content is available in the text.

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<![CDATA[Anxiety After Stroke]]> https://www.researchpad.co/product?articleinfo=5bfaa651d5eed0c48473a5a1

Supplemental Digital Content is available in the text.

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<![CDATA[Clinical Evaluation of a Skin Protectant for the Management of Incontinence-Associated Dermatitis]]> https://www.researchpad.co/product?articleinfo=5b379ccf463d7e6dd68542bb

PURPOSE:

The purpose of this study was to evaluate the efficacy of an investigational skin protectant product at managing severe skin breakdown associated with incontinence.

DESIGN:

Open-label, nonrandomized, prospective study.

SUBJECTS AND SETTING:

The sample comprised 16 patients; inclusion criteria were: patients older than 18 years, cared for in the intensive care unit of a level I trauma center hospital or in long-term care facilities in the northeast region of the United States, and had incontinence-associated dermatitis (IAD). Twelve of the patients had epidermal skin loss and 4 had severe redness.

METHODS:

The investigational product is a formulation based on acrylate chemistry. The skin protectant application schedule was twice weekly for up to 3 weeks for a maximum of 6 applications during the study period. The skin was evaluated via a skin assessment instrument specifically designed for use in this study; this instrument has not undergone validation studies. The main outcome measure was changes in the instrument score over time. In addition, complete reepithelialization was recorded when observed, and pain scores (associated with IAD) were noted in participants who were able to report pain.

RESULTS:

The IAD score improved in 13 of 16 patients, remained unchanged in 1 patient, and deteriorated in 2 patients. The median percent improvement in the skin assessment instrument was 96% (P = .013). Four of the patients with epidermal skin loss had complete reepithelialization of the skin surface with 4 to 6 applications of the skin protectant, and 5 had substantial improvement. The 4 patients with severe red skin returned to healthy normal skin with 2 to 4 skin protectant applications. Substantial pain reduction was reported by all 9 patients who reported pain at enrollment. No adverse events associated with the skin protectant application were reported during data collection.

CONCLUSION:

Results of this study suggest that an acrylate-based product, evaluated here for the first time in patients, may be effective as a protective barrier in the presence of continued incontinence. Additional research is needed to confirm these findings.

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<![CDATA[Keloid Management: A Retrospective Case Review on a New Approach Using Surgical Excision, Platelet-Rich Plasma, and In-office Superficial Photon X-ray Radiation Therapy]]> https://www.researchpad.co/product?articleinfo=5bccadad40307c364ce7ade7 <![CDATA[An Automated and Minimally Invasive Tool for Generating Autologous Viable Epidermal Micrografts]]> https://www.researchpad.co/product?articleinfo=5bc6d51340307c648397aabb

ABSTRACT

OBJECTIVE:

A new epidermal harvesting tool (CelluTome; Kinetic Concepts, Inc, San Antonio, Texas) created epidermal micrografts with minimal donor site damage, increased expansion ratios, and did not require the use of an operating room. The tool, which applies both heat and suction concurrently to normal skin, was used to produce epidermal micrografts that were assessed for uniform viability, donor-site healing, and discomfort during and after the epidermal harvesting procedure.

DESIGN:

This study was a prospective, noncomparative institutional review board–approved healthy human study to assess epidermal graft viability, donor-site morbidity, and patient experience.

SETTING:

These studies were conducted at the multispecialty research facility, Clinical Trials of Texas, Inc, San Antonio.

PATIENTS:

The participants were 15 healthy human volunteers.

RESULTS:

The average viability of epidermal micrografts was 99.5%. Skin assessment determined that 76% to 100% of the area of all donor sites was the same in appearance as the surrounding skin within 14 days after epidermal harvest. A mean pain of 1.3 (on a scale of 1 to 5) was reported throughout the harvesting process.

CONCLUSIONS:

Use of this automated, minimally invasive harvesting system provided a simple, low-cost method of producing uniformly viable autologous epidermal micrografts with minimal patient discomfort and superficial donor-site wound healing within 2 weeks.

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<![CDATA[Cultures of Diabetic Foot Ulcers Without Clinical Signs of Infection Do Not Predict Outcomes]]> https://www.researchpad.co/product?articleinfo=5bc262b840307c2017bbd1b2

OBJECTIVE

We examined associations between ulcer bioburden and ulcer outcomes in neuropathic diabetic foot ulcers (DFUs) that lacked clinical signs of infection.

RESEARCH DESIGN AND METHODS

Three dimensions of bioburden (i.e., microbial load, microbial diversity, and the presence of likely pathogens) were measured at baseline using swab cultures obtained by Levine’s technique. Subjects were assessed every 2 weeks for 26 weeks to determine the rate of healing and development of infection-related complications. Foot ulcers were off-loaded using total-contact casts and routinely debrided. To establish associations between bioburden and rate of healing, Cox proportional hazards and least squares regression were used after adjusting for ulcer depth, surface area, and duration.

RESULTS

A total of 77 subjects completed the study. Sixty-five (84.4%) had ulcers that healed during follow-up; weeks-to-closure ranged from 2 to 26 (median 4.0). Mean (± SD) percent reduction in surface area/week was 25.0% (± 23.33). Five (6.5%) of the DFUs developed an infection-related complication. None of the bioburden dimensions (i.e., microbial load, microbial diversity, or presence of likely pathogens) was significantly associated with weeks-to-closure or percent reduction in surface area per week. Weeks-to-closure was best predicted by ulcer duration, depth, and surface area (c-statistic = 0.75).

CONCLUSIONS

Culturing DFUs that showed no clinical signs of infection had no predictive value for outcomes of DFUs managed with total-contact casts and routine debridement. These findings support recommendations of the Infectious Disease Society of America that culturing and antibiotics should be avoided in treating DFUs that show no clinical signs of infection.

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<![CDATA[Effect of 8 Weeks of Overfeeding on Ectopic Fat Deposition and Insulin Sensitivity: Testing the “Adipose Tissue Expandability” Hypothesis]]> https://www.researchpad.co/product?articleinfo=5bc262c040307c2017bbd1b5

OBJECTIVE

The presence of large subcutaneous adipocytes in obesity has been proposed to be linked with insulin resistance and type 2 diabetes through the “adipose tissue expandability” hypothesis, which holds that large adipocytes have a limited capacity for expansion, forcing lipids to be stored in nonadipose ectopic depots (skeletal muscle, liver), where they interfere with insulin signaling. This hypothesis has, however, been largely formulated by cross-sectional findings and to date has not been prospectively demonstrated in the development of insulin resistance in humans.

RESEARCH DESIGN AND METHODS

Twenty-nine men (26.8 ± 5.4 years old; BMI 25.5 ± 2.3 kg/m2) were fed 40% more than their baseline requirement for 8 weeks. Before and after overfeeding, insulin sensitivity was determined using a two-step hyperinsulinemic-euglycemic clamp. Intrahepatic lipid (IHL) and intramyocellular lipid (IMCL) were measured by 1H-MRS and abdominal fat by MRI. Subcutaneous abdominal adipose and skeletal muscle tissues were collected to measure adipocyte size and markers of tissue inflammation.

RESULTS

Subjects gained 7.6 ± 2.1 kg (55% fat) and insulin sensitivity decreased 18% (P < 0.001) after overfeeding. IHL increased 46% from 1.5% to 2.2% (P = 0.002); however, IMCL did not change. There was no association between adipocyte size and ectopic lipid accumulation. Despite similar weight gain, subjects with smaller fat cells at baseline had a greater decrease in insulin sensitivity, which was linked with upregulated skeletal muscle tissue inflammation.

CONCLUSIONS

In experimental substantial weight gain, the presence of larger adipocytes did not promote ectopic lipid accumulation. In contrast, smaller fat cells were associated with a worsened metabolic response to overfeeding.

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<![CDATA[Effects of Weight Loss, Weight Cycling, and Weight Loss Maintenance on Diabetes Incidence and Change in Cardiometabolic Traits in the Diabetes Prevention Program]]> https://www.researchpad.co/product?articleinfo=5bc262bd40307c2017bbd1b4

OBJECTIVE

This study examined specific measures of weight loss in relation to incident diabetes and improvement in cardiometabolic risk factors.

RESEARCH DESIGN AND METHODS

This prospective, observational study analyzed nine weight measures, characterizing baseline weight, short- versus long-term weight loss, short- versus long-term weight regain, and weight cycling, within the Diabetes Prevention Program (DPP) lifestyle intervention arm (n = 1,000) for predictors of incident diabetes and improvement in cardiometabolic risk factors over 2 years.

RESULTS

Although weight loss in the first 6 months was protective of diabetes (hazard ratio [HR] 0.94 per kg, 95% CI 0.90, 0.98; P < 0.01) and cardiometabolic risk factors (P < 0.01), weight loss from 0 to 2 years was the strongest predictor of reduced diabetes incidence (HR 0.90 per kg, 95% CI 0.87, 0.93; P < 0.01) and cardiometabolic risk factor improvement (e.g., fasting glucose: β = −0.57 mg/dL per kg, 95% CI −0.66, −0.48; P < 0.01). Weight cycling (defined as number of 5-lb [2.25-kg] weight cycles) ranged 0–6 times per participant and was positively associated with incident diabetes (HR 1.33, 95% CI 1.12, 1.58; P < 0.01), fasting glucose (β = 0.91 mg/dL per cycle; P = 0.02), HOMA-IR (β = 0.25 units per cycle; P = 0.04), and systolic blood pressure (β = 0.94 mmHg per cycle; P = 0.01). After adjustment for baseline weight, the effect of weight cycling remained statistically significant for diabetes risk (HR 1.22, 95% CI 1.02, 1.47; P = 0.03) but not for cardiometabolic traits.

CONCLUSIONS

Two-year weight loss was the strongest predictor of reduced diabetes risk and improvements in cardiometabolic traits.

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<![CDATA[Blood Pressure and Pulse Pressure Effects on Renal Outcomes in the Veterans Affairs Diabetes Trial (VADT)]]> https://www.researchpad.co/product?articleinfo=5bc262c540307c2017bbd1b7

OBJECTIVE

Blood pressure (BP) control for renal protection is essential for patients with type 2 diabetes. Our objective in this analysis of Veterans Affairs Diabetes Trial (VADT) data was to learn whether on-study systolic BP (SBP), diastolic BP (DBP), and pulse pressure (PP) affected renal outcomes measured as albumin-to-creatinine ratio (ACR) and estimated glomerular filtration rate (eGFR).

RESEARCH DESIGN AND METHODS

The VADT was a prospective, randomized study of 1,791 veterans with type 2 diabetes to determine whether intensive glucose control prevented major cardiovascular events. In this post hoc study, time-varying covariate survival analyses and hazard ratios (HR) were used to determine worsening of renal outcomes.

RESULTS

Compared with SBP 105–129 mmHg, the risk of ACR worsening increased significantly for SBP 130–139 mmHg (HR 1.88 [95% CI 1.28–2.77]; P = 0.001) and for SBP ≥140 mmHg (2.51 [1.66–3.78]; P < 0.0001). Compared with a PP range of 40–49 mmHg, PP <40 was associated with significantly lowered risk of worsening ACR (0.36 [0.15–0.87]; P = 0.022) and PP ≥60 with significantly increased risk (2.38 [1.58–3.59]; P < 0.0001). Analyses of BP ranges associated with eGFR worsening showed significantly increased risk with rising baseline SBP and an interaction effect between SBP ≥140 mmHg and on-study A1C. These patients were 15% more likely than those with SBP <140 mmHg to experience eGFR worsening (1.15 [1.00–1.32]; P = 0.045) for each 1% (10.9 mmol/mol) A1C increase.

CONCLUSIONS

SBP ≥130 mmHg and PP >60 mmHg were associated with worsening ACR. The results suggest that treatment of SBP to <130 mmHg may lessen ACR worsening. The interaction between SBP ≥140 mmHg and A1C suggests that the effect of glycemic control on reducing progression of renal disease may be greater in hypertensive patients.

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<![CDATA[Do Experiences Consistent With a Medical-Home Model Improve Diabetes Care Measures Reported by Adult Medicaid Patients?]]> https://www.researchpad.co/product?articleinfo=5bc15d4e40307c11974ebc95

OBJECTIVE

The patient-centered medical home has gained much traction. Little is known about the relationship between the model and specific health care processes for chronic diseases such as diabetes. This study assesses the impact of features of a medical home on diabetes care.

RESEARCH DESIGN AND METHODS

A cross-sectional survey of 540 patients with Medicaid (Medi-Cal) health insurance and type 2 diabetes in Los Angeles County was performed. The Primary Care Assessment Tools was used to measure seven features of medical-home performance.

RESULTS

The response rate of the patient survey was 68.9%. Patient-reported medical-home performance averaged a score of 2.85 ± 0.29 (on a 1–4 scale, with 4 equaling the best care). Patients who received more timely and thorough diabetes care reported higher medical-home performance in every feature except for the comprehensiveness-services available. For example, the first-contact access feature score was higher among patients who had an HbA1c test in the past 6 months versus those who did not (2.38 vs. 2.25; P < 0.05). Before and after adjusting for sociodemographics and health status, total medical-home performance was positively associated with each diabetes care measure. A 1-point increase in total medical-home score was associated with 4.53 higher odds of an HbA1c test in the past 6 months and 1.88 higher odds of an eye exam in the past year.

CONCLUSIONS

Features consistent with higher medical-home performance are associated with improvements in patient-reported diabetes care process measures, even in this low socioeconomic status setting. The patient-centered medical-home model may help in caring for people with type 2 diabetes.

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<![CDATA[Food-Insecure Dietary Patterns Are Associated With Poor Longitudinal Glycemic Control in Diabetes: Results From the Boston Puerto Rican Health Study]]> https://www.researchpad.co/product?articleinfo=5bc15d4c40307c11974ebc94

OBJECTIVE

To determine whether dietary patterns associated with food insecurity are associated with poor longitudinal glycemic control.

RESEARCH DESIGN AND METHODS

In a prospective, population-based, longitudinal cohort study, we ascertained food security (Food Security Survey Module), dietary pattern (Healthy Eating Index–2005 [HEI 2005]), and hemoglobin A1c (HbA1c) in Puerto Rican adults aged 45–75 years with diabetes at baseline (2004–2009) and HbA1c at ∼2 years follow-up (2006–2012). We determined associations between food insecurity and dietary pattern and assessed whether those dietary patterns were associated with poorer HbA1c concentration over time, using multivariable-adjusted repeated subjects mixed-effects models.

RESULTS

There were 584 participants with diabetes at baseline and 516 at follow-up. Food-insecure participants reported lower overall dietary quality and lower intake of fruit and vegetables. A food insecurity*HEI 2005 interaction (P < 0.001) suggested that better diet quality was more strongly associated with lower HbA1c in food-insecure than food-secure participants. In adjusted models, lower follow-up HbA1c was associated with greater HEI 2005 score (β = −0.01 HbA1c % per HEI 2005 point, per year, P = 0.003) and with subscores of total vegetables (β = −0.09, P = 0.04) and dark green and orange vegetables and legumes (β = −0.06, P = 0.048). Compared with the minimum total vegetable score, a participant with the maximum score showed relative improvements of HbA1c of 0.5% per year.

CONCLUSIONS

Food insecurity was associated with lower overall dietary quality and lower consumption of plant-based foods, which was associated with poor longitudinal glycemic control.

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<![CDATA[Regression From Prediabetes to Normal Glucose Regulation Is Associated With Reduction in Cardiovascular Risk: Results From the Diabetes Prevention Program Outcomes Study]]> https://www.researchpad.co/product?articleinfo=5bc15d3f40307c11974ebc8f

OBJECTIVE

Restoration of normal glucose regulation (NGR) in people with prediabetes significantly decreases the risk of future diabetes. We sought to examine whether regression to NGR is also associated with a long-term decrease in cardiovascular disease (CVD) risk.

RESEARCH DESIGN AND METHODS

The Framingham (2008) score (as an estimate of the global 10-year CVD risk) and individual CVD risk factors were calculated annually for the Diabetes Prevention Program Outcomes Study years 1–10 among those patients who returned to NGR at least once during the Diabetes Prevention Program (DPP) compared with those who remained with prediabetes or those in whom diabetes developed during DPP (N = 2,775).

RESULTS

The Framingham scores by glycemic exposure did not differ among the treatment groups; therefore, pooled estimates were stratified by glycemic status and were adjusted for differences in risk factors at DPP baseline and in the treatment arm. During 10 years of follow-up, the mean Framingham 10-year CVD risk scores were highest in the prediabetes group (16.2%), intermediate in the NGR group (15.5%), and 14.4% in people with diabetes (all pairwise comparisons P < 0.05), but scores decreased over time for those people with prediabetes (18.6% in year 1 vs. 15.9% in year 10, P < 0.01). The lower score in the diabetes group versus other groups, a declining score in the prediabetes group, and favorable changes in each individual risk factor in all groups were explained, in part, by higher or increasing medication use for lipids and blood pressure.

CONCLUSIONS

Prediabetes represents a high-risk state for CVD. Restoration of NGR and/or medical treatment of CVD risk factors can significantly reduce the estimated CVD risk in people with prediabetes.

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<![CDATA[Metabolite Traits and Genetic Risk Provide Complementary Information for the Prediction of Future Type 2 Diabetes]]> https://www.researchpad.co/product?articleinfo=5bc15d3b40307c11974ebc8e

OBJECTIVE

A genetic risk score (GRS) comprised of single nucleotide polymorphisms (SNPs) and metabolite biomarkers have each been shown, separately, to predict incident type 2 diabetes. We tested whether genetic and metabolite markers provide complementary information for type 2 diabetes prediction and, together, improve the accuracy of prediction models containing clinical traits.

RESEARCH DESIGN AND METHODS

Diabetes risk was modeled with a 62-SNP GRS, nine metabolites, and clinical traits. We fit age- and sex-adjusted logistic regression models to test the association of these sources of information, separately and jointly, with incident type 2 diabetes among 1,622 initially nondiabetic participants from the Framingham Offspring Study. The predictive capacity of each model was assessed by area under the curve (AUC).

RESULTS

Two hundred and six new diabetes cases were observed during 13.5 years of follow-up. The AUC was greater for the model containing the GRS and metabolite measurements together versus GRS or metabolites alone (0.820 vs. 0.641, P < 0.0001, or 0.820 vs. 0.803, P = 0.01, respectively). Odds ratios for association of GRS or metabolites with type 2 diabetes were not attenuated in the combined model. The AUC was greater for the model containing the GRS, metabolites, and clinical traits versus clinical traits only (0.880 vs. 0.856, P = 0.002).

CONCLUSIONS

Metabolite and genetic traits provide complementary information to each other for the prediction of future type 2 diabetes. These novel markers of diabetes risk modestly improve the predictive accuracy of incident type 2 diabetes based only on traditional clinical risk factors.

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<![CDATA[Effect of Exenatide, Sitagliptin, or Glimepiride on β-Cell Secretory Capacity in Early Type 2 Diabetes]]> https://www.researchpad.co/product?articleinfo=5bc15d4440307c11974ebc91

OBJECTIVE

Agents that augment GLP-1 effects enhance glucose-dependent β-cell insulin production and secretion and thus are hoped to prevent progressive impairment in insulin secretion characteristic of type 2 diabetes (T2D). The purpose of this study was to evaluate GLP-1 effects on β-cell secretory capacity, an in vivo measure of functional β-cell mass, early in the course of T2D.

RESEARCH DESIGN AND METHODS

We conducted a randomized controlled trial in 40 subjects with early T2D who received the GLP-1 analog exenatide (n = 14), the dipeptidyl peptidase IV inhibitor sitagliptin (n = 12), or the sulfonylurea glimepiride (n = 14) as an active comparator insulin secretagogue for 6 months. Acute insulin responses to arginine (AIRarg) were measured at baseline and after 6 months of treatment with 5 days of drug washout under fasting, 230 mg/dL (glucose potentiation of arginine-induced insulin release [AIRpot]), and 340 mg/dL (maximum arginine-induced insulin release [AIRmax]) hyperglycemic clamp conditions, in which AIRmax provides the β-cell secretory capacity.

RESULTS

The change in AIRpot was significantly greater with glimepiride versus exenatide treatment (P < 0.05), and a similar trend was notable for the change in AIRmax (P = 0.1). Within each group, the primary outcome measure, AIRmax, was unchanged after 6 months of treatment with exenatide or sitagliptin compared with baseline but was increased with glimepiride (P < 0.05). α-Cell glucagon secretion (AGRmin) was also increased with glimepiride treatment (P < 0.05), and the change in AGRmin trended higher with glimepiride than with exenatide (P = 0.06).

CONCLUSIONS

After 6 months of treatment, exenatide or sitagliptin had no significant effect on functional β-cell mass as measured by β-cell secretory capacity, whereas glimepiride appeared to enhance β- and α-cell secretion.

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<![CDATA[Synergism Between Circulating Tumor Necrosis Factor Receptor 2 and HbA1cin Determining Renal Decline During 5–18 Years of Follow-up in Patients With Type 1 Diabetes and Proteinuria]]> https://www.researchpad.co/product?articleinfo=5bc15d3640307c11974ebc8c

OBJECTIVE

We studied the serum concentration of tumor necrosis factor receptor 2 (TNFR2) and the rate of renal decline, a measure of the intensity of the disease process leading to end-stage renal disease (ESRD).

RESEARCH DESIGN AND METHODS

A cohort of 349 type 1 diabetic patients with proteinuria was followed for 5–18 years. Serum TNFR2, glycated hemoglobin A1c (HbA1c), and other characteristics were measured at enrollment. We used a novel analytic approach, a joint longitudinal-survival model, fitted to serial estimates of glomerular filtration rate (eGFR) based on serum creatinine (median seven per patient) and time to onset of ESRD (112 patients) to estimate the rate of renal decline (eGFR loss).

RESULTS

At enrollment, all patients had chronic kidney disease stage 1–3. The mean (±SD) rate of eGFR loss during 5–18 years of follow-up was −5.2 (±4.9) mL/min/1.73 m2/year. Serum TNFR2 was the strongest determinant of renal decline and ESRD risk (C-index 0.79). The rate of eGFR loss became steeper with rising concentration of TNFR2, and elevated HbA1c augmented the strength of this association (P = 0.030 for interaction). In patients with HbA1c ≥10.1% (87 mmol/mol), the difference in the rate of eGFR loss between the first and fourth quartiles of TNFR2 was 5.4 mL/min/1.73 m2/year, whereas it was only 1.9 in those with HbA1c <7.9% (63 mmol/mol).

CONCLUSIONS

Circulating TNFR2 is a major determinant of renal decline in patients with type 1 diabetes and proteinuria. Elevated HbA1c magnifies its effect. Although the mechanisms of this synergism are unknown, our findings allow us to stratify patients according to risk of ESRD.

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<![CDATA[Association Between Impaired Cardiovascular Autonomic Function and Hypoglycemia in Patients With Type 1 Diabetes]]> https://www.researchpad.co/product?articleinfo=5bc15d4740307c11974ebc92

OBJECTIVE

We studied the association between glycemic variability (GV) reflecting hypoglycemic stress and cardiovascular autonomic function in subjects with type 1 diabetes.

RESEARCH DESIGN AND METHODS

Forty-four type 1 diabetic patients (mean age 34 ± 13 years, 40% male, 86% Caucasian, mean diabetes duration 13 ± 6 years, mean hemoglobin A1c [HbA1c] 8.0 ± 1.2% [64 ± 5 mmol/mol]) without cardiovascular disease, dyslipidemia, or hypertension participated in this pilot study. Indices of GV reflective of hypoglycemic stress (low blood glucose index [LBGI] and area under the curve [AUC] for hypoglycemia) were computed using data obtained during 5-day continuous glucose monitoring. Cardiovascular autonomic neuropathy (CAN) was assessed using standardized cardiovascular reflex testing and measures of heart rate variability (HRV), which were analyzed as time and frequency domain measures.

RESULTS

Both LBGI and AUC hypoglycemia had a significant negative association with the low-frequency power of HRV (r = −0.47, P = 0.002; r = −0.43, P = 0.005, respectively) and with the high-frequency power of HRV (r = −0.37, P = 0.018; r = −0.38, P = 0.015, respectively). These inverse associations persisted after adjusting for HbA1c, although they were attenuated in multivariable analysis after adjustment for age, diabetes duration, and several other covariates.

CONCLUSIONS

Increased GV promoting hypoglycemic stress was associated with reduced HRV independent of glycemic control as assessed by HbA1c. These pilot data suggest that glucose variability may contribute to cardiovascular autonomic dysfunction among adults with type 1 diabetes.

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<![CDATA[Corneal Confocal Microscopy Detects Neuropathy in Subjects With Impaired Glucose Tolerance]]> https://www.researchpad.co/product?articleinfo=5bc15d4240307c11974ebc90

OBJECTIVE

Impaired glucose tolerance (IGT) represents one of the earliest stages of glucose dysregulation and is associated with macrovascular disease, retinopathy, and microalbuminuria, but whether IGT causes neuropathy is unclear.

RESEARCH DESIGN AND METHODS

Thirty-seven subjects with IGT and 20 age-matched control subjects underwent a comprehensive evaluation of neuropathy by assessing symptoms, neurological deficits, nerve conduction studies, quantitative sensory testing, heart rate variability deep breathing (HRVdb), skin biopsy, and corneal confocal microscopy (CCM).

RESULTS

Subjects with IGT had a significantly increased neuropathy symptom profile (P < 0.001), McGill pain index (P < 0.001), neuropathy disability score (P = 0.001), vibration perception threshold (P = 0.002), warm threshold (P = 0.006), and cool threshold (P = 0.03), with a reduction in intraepidermal nerve fiber density (P = 0.03), corneal nerve fiber density (P < 0.001), corneal nerve branch density (P = 0.002), and corneal nerve fiber length (P = 0.05). No significant difference was found in sensory and motor nerve amplitude and conduction velocity or HRVdb.

CONCLUSIONS

Subjects with IGT have evidence of neuropathy, particularly small-fiber damage, which can be detected using skin biopsy and CCM.

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<![CDATA[Outcomes of Combined Cardiovascular Risk Factor Management Strategies in Type 2 Diabetes: The ACCORD Randomized Trial]]> https://www.researchpad.co/product?articleinfo=5bbeff9940307c38ebdd5a06

OBJECTIVE

To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.

RESEARCH DESIGN AND METHODS

ACCORD enrolled 10,251 type 2 diabetes patients aged 40–79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of <6.0% (<42 mmol/mol; intensive glycemia) or 7.0–7.9% (53–63 mmol/mol; standard glycemia) and then randomized a second time to either 1) systolic BP goals of <120 mmHg (intensive BP) or <140 mmHg (standard BP) or 2) simvastatin plus fenofibrate (intensive lipid) or simvastatin plus placebo (standard lipid). Proportional hazards models were used to assess combinations of treatment assignments on the composite primary (deaths due to CVD, nonfatal myocardial infarction [MI], and nonfatal stroke) and secondary outcomes.

RESULTS

In the BP trial, risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50–0.91), BP (HR 0.74; 95% CI 0.55–1.00), or both (HR 0.71; 95% CI 0.52–0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02–1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group.

CONCLUSIONS

In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality.

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<![CDATA[Impact of Intensive Lifestyle Intervention on Depression and Health-Related Quality of Life in Type 2 Diabetes: The Look AHEAD Trial]]> https://www.researchpad.co/product?articleinfo=5bbeffa540307c38ebdd5a0a

OBJECTIVE

We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes.

RESEARCH DESIGN AND METHODS

Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1–4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores.

RESULTS

ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75–0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores.

CONCLUSIONS

ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.

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<![CDATA[Comment on Moore et al. Increased Risk of Cognitive Impairment in Patients With Diabetes Is Associated With Metformin. Diabetes Care 2013;36:2981–2987]]> https://www.researchpad.co/product?articleinfo=5bbeffa240307c38ebdd5a09 ]]>