Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes.

OBJECTIVES: Evaluate effects of a theoretically-based, semi-intensive (Face-to-Face; F2F) exercise intervention and minimum-contact (Home) exercise intervention to the standard care (Control) on exercise, its motivational determinants, blood glucose levels, and insulin use of pregnant women with gestational diabetes mellitus (GDM). DESIGN: Randomized control trial with two intervention arms and control (standard care). METHOD: Participants (N=65) were randomized to a Control (standard prenatal care/GDM dietary counseling), Home (standard care + phone education/support + home exercise), or F2F (standard care + on-site education/support + guided exercise with instructor on 2 days/week) group from ~20 weeks gestation to delivery. Assessments of exercise and motivational determinants were obtained at baseline (20-weeks gestation) and follow-up (32-weeks gestation). Blood glucose levels (fasting/postprandial mg/dL) and insulin use were extrapolated from medical records. RESULTS: At the 32-week follow-up, the F2F group had significantly higher exercise min, pedometer steps/day, and motivational determinants (attitude, subjective norm, perceived control, intention) than controls (p's < .05) and significantly higher exercise min and subjective norm than the Home group (p's < .05); these effect sizes were medium-large (η2 = .11-.23). There was a medium effect (η2 = .13) on postprandial blood glucose at 36-weeks gestation with the F2F group having lower values than controls. Although not significant, the F2F group started insulin later (33 weeks gestation) than the Home (27 weeks) and Control (31 weeks) groups. CONCLUSION: A theoretically-based, F2F exercise intervention has multiple health benefits and may be the necessary approach for promoting exercise motivation and behavior among GDM women.

Attributing discrimination to weight: associations with well-being, self-care, and disease status in patients with type 2 diabetes mellitus.

This study examined the association between attributing self-reported discrimination to weight and diabetes outcomes (glycemic control, diabetes-related distress, and diabetes self-care). A community dwelling sample of 185 adults (mean age 55.4; 80 % White/Caucasian 65 % female) with poorly controlled type 2 diabetes (HbA1c level ≥ 7.5 %) provided demographic and several self-report measures (including diabetes-related distress, diabetes self-care activities, discrimination, and attributions of discrimination), and had height, weight, and glycated hemoglobin (HbA1c) assessed by trained research staff as part of a larger research study. Individuals who attributed self-reported discrimination to weight had significantly higher HbA1c levels, higher levels of diabetes-related distress, and worse diabetes-related self-care behaviors (general diet, exercise, and glucose testing). These relationships persisted even when controlling for BMI, overall discrimination, depressive symptoms, and demographic characteristics. Results indicate that the perception of weight stigma among individuals with type 2 diabetes is strongly associated with a range of poor diabetes outcomes. Efforts to reduce exposure to and/or teach adaptive coping for weight stigma may benefit patients with type 2 diabetes.

Prevalence of diabetes and associated obesity in Pennsylvania adults, 1995-2010.

INTRODUCTION: This study examined trends in the prevalence and sociodemographic distributions of diabetes and the associations of diabetes with obesity over time in adult Pennsylvanians from 1995 through 2010. METHODS: We used Behavioral Risk Factor Surveillance Survey data collected from 1995 through 2010. Diabetes prevalence was assessed by self-report of physician diagnosis. Obesity was assessed by body mass index computed from self-report of height and weight. State-level data for diabetes and associated obesity prevalence from 1995 through 2010 were collected for each year. Data on sociodemographic factors (age, sex, race, income, education) and 1 known disease risk factor (obesity) were also collected. Logistic regression modeling was used to examine associations between diabetes, sociodemographic factors, and obesity. RESULTS: Diabetes prevalence in Pennsylvania, which increased from 5.6% in 1995 to 10.5% in 2010, followed national trends but exceeded the national prevalence each year by approximately 0.6 percentage points for 12 of the 16 years. The increase in prevalence was not equal across all socioeconomic groups. Obesity became a more dominant risk factor for diabetes during these 16 years. CONCLUSION: The burden of diabetes and obesity in Pennsylvania is substantial and increasing. Program managers and policy makers in Pennsylvania should consider these trends when allocating limited resources and designing programs for reducing diabetes-related illness. Other states may consider similar studies to monitor the prevalence of diabetes and determine whether disparities are changing and whether programs and resources should also shift.

Baclofen reduces binge eating in a double-blind, placebo-controlled, crossover study.

Baclofen has shown promise in treating substance use disorders and also reduced binge frequency in an open-label trial. This placebo-controlled, double-blind, crossover study further assessed the effects of baclofen on binge eating. Twelve individuals who self-reported binge eating completed the study. Data were collected during a run-in period (no drug or placebo), placebo phase (48 days), and baclofen phase (titrated up to 60 mg daily or the maximum tolerated dose, 48 days). All the participants were exposed to all conditions. Participants completed a binge diary daily, and the Binge Eating Scale (BES), Food Craving Inventory-II (FCI-II), and Hospital Anxiety and Depression Scale (HADS) at regular intervals throughout the study. Baclofen significantly reduced binge frequency relative to placebo and run-in (P<0.05). This confirms results from the previous open-label trial. Baclofen also produced slight, but significant, increases in depression symptomatology as assessed by the HADS. Binge severity (BES scores) and craving (FCI-II scores) were significantly reduced during placebo and baclofen phases, that is both measures exhibited significant placebo effects. Tiredness, fatigue, and upset stomach were the most commonly reported side-effects. These results indicate that baclofen may be a useful treatment for binge eating in some patients.

Consumption of a legume-enriched, low-glycemic index diet is associated with biomarkers of insulin resistance and inflammation among men at risk for colorectal cancer.

The Legume Inflammation Feeding Experiment is, to our knowledge, the first randomized crossover feeding trial testing the effects of a legume-enriched, low-glycemic index (GI) diet among men characterized for colorectal adenomas and insulin resistance (IR) status. This study was designed to test the effects of a legume-enriched diet compared with a healthy American (HA) diet under weight-stable conditions. The primary objective was to assess effects on C-reactive protein (CRP) and C-peptide levels. The secondary objective was to assess changes by IR status or history of adenomas. A total of 64 men who completed a colonoscopy within the previous 2 y consumed 2 diets in random order each for 4 wk separated by a washout period. The diets were a legume-enriched (250 g/d), low-GI (GI 38) diet and a high-GI (GI 69) HA diet. We measured fasting glucose, insulin, C-peptide, CRP, and soluble tumor necrosis factor-alpha receptors I and II (sTNFRI/II) at the beginning and end of the diet periods. Participants who consumed both the legume and HA diets had favorably improved CRP (-20.2 and -18.3%) and sTNFRI (-3.7 and -4.4%) concentrations, respectively. The sTNFRII concentrations declined marginally during the legume diet period (-3.8%; P = 0.060) and significantly during the HA diet period (-5.1%; P < 0.001). Fasting glucose increased significantly during both the legume (+1.8%) and HA (-2.2%) diet periods. Only the changes in glucose differed between the diet periods. Serum C-peptide and plasma insulin levels did not change in participants consuming either diet. Healthful dietary changes can improve biomarkers of IR and inflammation.

Identifying barriers that hinder onsite parental involvement in a school-based health promotion program.

We investigated whether barriers to onsite parental involvement in the Bienestar Health Program Parent Component could be identified and whether participation rates could be increased by addressing these barriers. All nonparticipating parents of fourth-grade students of San Antonio Independent School District from 4 schools, which were selected randomly from 20 intervention schools in Bienestar, were invited to take part in this study. A total of 47 of 223 (21%) parents engaged in one of four focus groups offered. Parents identified barriers to their involvement in Bienestar that fit into five descriptive categories: (a) low value, (b) high cost, (c) competing family demands, (d) concerns about the program design, and (e) social role norms. The Bienestar Parent Component was then modified according to the focus group findings, which resulted in a marked increase in parental involvement from 17% to 37% overall. These findings suggest that even when parents are involved in the initial design of parent-friendly and culturally sensitive programs, as was the case for Bienestar, maximizing parental involvement may require additional assessment, identification, and remediation of barriers.

Unique relations between post-traumatic stress disorder symptoms and patient functioning in type 2 diabetes.

This study examined reported post-traumatic stress disorder symptoms in adults with poorly controlled type 2 diabetes who had no history of psychiatric diagnosis or treatment (n = 184, MHbA1c = 9.13%, standard deviation = 1.68). Participants reported moderate to severe intensity of post-traumatic stress disorder symptoms (M = 19.17, SD = 17.58). Together, depressive and post-traumatic stress disorder symptoms accounted for 10-40 percent of the variance in type 2 diabetes outcomes; post-traumatic stress disorder symptoms were associated with elevated diabetes distress and more frequent exercise and self-blood glucose testing (unique R2 ~ 3%). Post-traumatic stress disorder symptoms may be overlooked in type 2 diabetes among patients without formal psychiatric diagnoses, and warrant increased attention.

The Charcot foot: medical and surgical therapy.

Charcot neuro-osteoarthropathy (CN) is among the most devastating complications of neuropathy and now most commonly occurs in the feet of diabetic patients. Because it is relatively rare and because most patients and practitioners do not expect major bone pathology in the absence of significant pain, CN is often misdiagnosed as cellulitis, deep venous thrombosis, or gout. Also, radiographs early in the process are often relatively unremarkable. Although MRI findings are characteristic, treatment should not wait for the MRI result. The hot swollen erythematous neuropathic foot suspected to be CN should be emergently mechanically protected, usually in an irremovable total contact cast. Mechanical protection is the mainstay of conservative therapy, but surgical reconstruction of a deformed foot can usually also be successful. Unless diagnosed very early, significant decrements in quality of life result. Controlled studies are urgently needed to identify best practices.

Understanding exercise beliefs and behaviors in women with gestational diabetes mellitus.

OBJECTIVE: The purpose of this study was to examine the exercise beliefs and behaviors of postpartum women who had gestational diabetes mellitus (GDM) during a recent pregnancy. RESEARCH DESIGN AND METHODS: Postpartum women with GDM (n = 28) completed a mail survey assessing their self-reported exercise beliefs (advantages, barriers, and important social influences) and behaviors. RESULTS: We found that 1) the strongest perceived advantage of exercise during pregnancy was controlling blood glucose and postpartum it was controlling weight, 2) the most common barrier to exercise during pregnancy was fatigue and postpartum it was a lack of time, 3) women's husband/partner most strongly influenced their exercise during pregnancy and postpartum, 4) women exercised more during the postpartum period than before or during pregnancy, and 5) the number of exercise advantages was positively associated with women's pregnancy and postpartum exercise behavior. CONCLUSIONS: To increase exercise behavior and reduce the risk of type 2 diabetes in women with GDM, researchers and health care professionals are encouraged to use women's exercise beliefs, that is, advantages, social influences, and perceived barriers to exercise, as a framework for designing effective diabetes treatment and prevention programs.

Patient Interpretation of Neuropathy (PIN) questionnaire: an instrument for assessment of cognitive and emotional factors associated with foot self-care.

OBJECTIVE: Using the common-sense model of illness behavior, we developed and validated a self-report instrument for assessment of patients' cognitive and emotional representations of diabetic peripheral neuropathy (DPN) influencing foot self-care. RESEARCH DESIGN AND METHODS: The Patient Interpretation of Neuropathy (PIN) questionnaire, generated from discussions with clinicians and interviews with patients with DPN, was administered to patients with DPN attending U.K. (n = 325) and U.S. (n = 170) diabetes centers. Psychometric tests of the PIN questionnaire comprised factor analysis, internal consistency, and test-retest reliability. Partial correlations and multivariate regressions established construct and criterion-related validity. The associations of PIN scales to past foot ulceration and foot self-care behaviors were compared with those using a generic measure of illness perception and emotion, the Revised Illness Perception Questionnaire (IPQ-R), which was adapted to neuropathy. RESULTS: Factor analysis of the PIN questionnaire produced 11 scales, which explained 69% of item variance. Nine factors measured patients' common-sense beliefs about DPN and their levels of understanding of DPN-related medical information. Two factors assessed the emotions of worry about potential consequences and anger at practitioners. Most scales demonstrated adequate internal (Cronbach's alpha = 0.62-0.90) and test-retest reliability (Pearson's r = 0.51-0.64). Partial correlations between the PIN and IPQ-R scales in corresponding domains were significant but modest (rp = 0.15-0.26). Finally, PIN scales showed significant associations with past foot ulceration and foot self-care behaviors, thereby confirming criterion validity. CONCLUSIONS: The 39-item PIN questionnaire is a reliable and valid measure of patients' cognitive and emotional representations of neuropathy affecting foot self-care.

The role of disease management in pay-for-performance programs for improving the care of chronically ill patients.

To date, pay-for-performance programs targeting the care of persons with chronic conditions have primarily been directed at physicians and provide an alternative to health plan-sponsored chronic disease management (DM) programs. Both approaches require similar infrastructure, and each has its own advantages and disadvantages for program implementation. Pay-for-performance programs use incentives based on patient outcomes; however, an alternative system might incorporate measures of structure and process. Using a conceptual framework, the authors explore the variation in 50 diabetes DM programs using data from the 2002 National Business Coalition on Health's eValue8 Request for Information (RFI). The authors raise issues relevant to the assignment of accountability for patient outcomes to either health plans or physicians. They analyze the association between RFI scores measuring structures and processes, and HEDIS diabetes intermediate outcome measures. Finally, the strengths and weaknesses of using the RFI scores as an alternative metric for pay-for-performance programs are discussed.

An inverse finite-element model of heel-pad indentation.

A numerical-experimental approach has been developed to characterize heel-pad deformation at the material level. Left and right heels of 20 diabetic subjects and 20 nondiabetic subjects matched for age, gender and body mass index were indented using force-controlled ultrasound. Initial tissue thickness and deformation were measured using M-mode ultrasound; indentation forces were recorded simultaneously. An inverse finite-element analysis of the indentation protocol using axisymmetric models adjusted to reflect individual heel thickness was used to extract nonlinear material properties describing the hyperelastic behavior of each heel. Student's t-tests revealed that heel pads of diabetic subjects were not significantly different in initial thickness nor were they stiffer than those from nondiabetic subjects. Another heel-pad model with anatomically realistic surface representations of the calcaneus and soft tissue was developed to estimate peak pressure prediction errors when average rather than individualized material properties were used. Root-mean-square errors of up to 7% were calculated, indicating the importance of subject-specific modeling of the nonlinear elastic behavior of the heel pad. Indentation systems combined with the presented numerical approach can provide this information for further analysis of patient-specific foot pathologies and therapeutic footwear designs.

Diabetic peripheral neuropathy and depressive symptoms: the association revisited.

OBJECTIVE: We examined the association between severity of diabetic peripheral neuropathy and depressive symptoms and investigated the potential mediators of this association. RESEARCH DESIGN AND METHODS: The Hospital Anxiety and Depression Scale (HADS) was used to assess depressive symptoms in 494 patients (mean age 62 years; 70% male; 72% type 2 diabetic) with diabetic neuropathy diagnosed by the Neuropathy Disability Score (NDS) and the Vibration Perception Threshold (VPT). Diabetic neuropathy symptoms, activities of daily living (ADLs), and social self-perception were measured by the neuropathy and foot ulcer-specific quality-of-life instrument, NeuroQoL; perceptions of diabetic neuropathy symptom unpredictability and the lack of effective treatment were assessed by the revised Illness Perception Questionnaire. RESULTS: Both the NDS and VPT were significantly associated with the HADS after controlling for demographic and disease variables. Although diabetic neuropathy symptoms mediated this association, with unsteadiness being most strongly associated with HADS, the relationship between foot ulceration and depression was nonsignificant. The association between diabetic neuropathy symptoms and HADS was partially mediated by two sets of psychosocial variables: 1) perceptions of diabetic neuropathy symptom unpredictability and the lack of treatment control and 2) restrictions in ADLs and changes in social self-perception. CONCLUSIONS: These findings establish the association between diabetic neuropathy and depressive symptoms and identify potential targets for interventions to alleviate depressive symptoms in persons affected by diabetic peripheral neuropathy.

Local plantar pressure relief in therapeutic footwear: design guidelines from finite element models.

A major goal of therapeutic footwear in patients with pain or those at risk for skin injury is to relieve focal loading under prominent metatarsal heads. One frequent approach is to place plugs of compliant material into the midsole of the shoe. This study investigated 36 plug designs, a combination of three materials, six geometries, and two placements using a two-dimensional (2D) finite element model. Realistic loading conditions were obtained from plantar pressures (PP) recorded during walking in five subjects who wore control midsoles manufactured using Microcell Puff. Measured peak pressures underneath the second metatarsal head were similar to the results of the control model. PP obtained from simulations with the plugs built into a firm midsole were compared to the simulation results of the control midsole. Large plugs (e.g. 40 mm width), made out of Microcell Puff Lite or Plastazote Medium, placed at peak pressure sites, resulted in highest reductions in peak pressures (18-28%). Smaller plugs benefited from tapering when placed at high pressure areas. Case studies were completed on a healthy male subject and a diabetic female patient to address the efficacy of a plug design favored by our simulations (pressure based placement, 40 x 20 mm, Plastazote Medium). Successful reductions of second metatarsal head pressures were observed with a mediolateral load redistribution that was not represented by our model. 2D computer simulations allowed systematic investigation of plug properties without the need for high volume experimentation on human subjects and established basic guidelines for plug selection. In particular, plugs that are placed based on plantar pressure measurements were proven to be more effective when compared to those positioned according to the projection of the bony landmark on the foot-shoe plantar contact area.

Effects of pistachios on the lipid/lipoprotein profile, glycemic control, inflammation, and endothelial function in type 2 diabetes: A randomized trial.

OBJECTIVE: The health benefits of regular nut consumption have been well-documented; however, effects on cardiovascular risk in diabetes are emerging. This study examined the effects of daily pistachio consumption on the lipid/lipoprotein profile, glycemic control, markers of inflammation, and endothelial function in adults with type 2 diabetes. MATERIALS/METHODS: We enrolled 30 adults (40-74 years) with well-controlled type 2 diabetes (mean glycated hemoglobin 6.2%) in a randomized, crossover, controlled feeding study. After a 2-week run-in period, participants consumed nutritionally-adequate diets with pistachios (contributing 20% of total energy) or without pistachios for 4 weeks each, separated by a 2-week washout. We assessed fasting lipids/lipoproteins, glycemic measures (while fasted and during a 75 g oral glucose tolerance test), inflammatory markers, and endothelial function after each diet period. RESULTS: Total cholesterol and the ratio of total to HDL cholesterol were significantly lower (p<0.05) following the pistachio diet (4.00 mmol/L and 4.06 mmol/L, respectively) compared to the control diet (4.15 mmol/L and 4.37 mmol/L, respectively). Triglycerides were significantly lower (p=0.003) following the pistachio diet (1.56 mmol/L) compared to the control diet (1.84 mmol/L). There were no treatment differences in fasting glucose and insulin, but fructosamine was significantly lower (p=0.03) following the pistachio diet (228.5 µmol/l) compared to the control diet (233.5 µmol/l). Inflammatory markers and endothelial function were unchanged. CONCLUSION: Daily pistachio consumption can improve some cardiometabolic risk factors in adults with well-controlled type 2 diabetes. Our findings support recommendations that individuals with diabetes follow healthy dietary patterns that include nuts.

Noninvasive assessment of hemodynamics: a comparative analysis of fingertip pulse contour analysis and impedance cardiography.

OBJECTIVE: Systemic hemodynamic assessment is useful for characterizing the underlying physiology of hypertension, selecting individualized treatment approaches, and understanding the underlying mechanisms of action of interventions. Invasive methods are not suitable for routine clinic or research use, and noninvasive methods such as impedance cardiography have technical and practical limitations. Fingertip pulse contour analysis using the Nexfin device is a novel alternative to noninvasive assessment of blood pressure and hemodynamics. Although both impedance cardiography and the Nexfin have been validated against invasive methods, the extent to which they are correlated with each other is unknown. This study is a comparative analysis of data simultaneously obtained by impedance cardiography and using the Nexfin device. METHODS: As part of a larger clinical trial, 13 adults with type 2 diabetes completed cardiovascular reactivity testing on three occasions: at study baseline and after two 4-week dietary treatment periods. Blood pressure, hemodynamics, and heart rate variability were assessed at rest and during acute mental stress. RESULTS: Blood pressure, heart rate, and heart rate variability data were significantly correlated between the two devices, but hemodynamic data (stroke volume, cardiac output, total peripheral resistance) were not significantly correlated. Both techniques detected treatment-related changes in blood pressure and total peripheral resistance, but significantly differed in the magnitude and/or direction of treatment effects. CONCLUSION: We conclude that Nexfin is not an appropriate alternative to impedance cardiography for measurement of underlying hemodynamics in psychophysiological research, but may be useful for beat-to-beat monitoring of blood pressure and heart rate variability.

Foot problems in diabetes: an overview.

Diabetes is the leading cause of nontraumatic lower-extremity amputations in the United States. Most amputations are preceded by an ulcer, and ulcers are costly in their own right. Most ulcers are neuropathic in etiology and plantar in location. They occur typically at sites of high mechanical loading because of repetitive trauma in people with loss of pain sensation. In an adequately perfused limb, such ulcers are not difficult to heal. When they are properly mechanically off-loaded, approximately 90% of these wounds heal in approximately 6 weeks. The reference standard off-loading device is the total contact cast, but other reasonably efficacious methods exist. Screening and implementation of preventive measures in the high-risk patient are highly recommended and can reduce the incidence of ulceration. All patients with diabetes should be screened annually for loss of protective sensation, with the 10-g Semmes-Weinstein monofilament being the easiest tool to use. Education to prevent complications should be implemented for all patients with loss of protective sensation.

Pressure relief and load redistribution by custom-made insoles in diabetic patients with neuropathy and foot deformity.

OBJECTIVE: To study the effects of custom-made insoles on plantar pressures and load redistribution in neuropathic diabetic patients with foot deformity. DESIGN: Cross-sectional. BACKGROUND: Although custom-made insoles are commonly prescribed to diabetic patients, little quantitative data on their mechanical action exists. METHODS: Regional in-shoe peak pressures and force-time integrals were measured during walking in the feet of 20 neuropathic diabetic subjects with foot deformity who wore flat or custom-made insoles. Twenty-one feet with elevated risk for ulceration at the first metatarsal head were analysed. Load redistribution resulting from custom-made insoles was assessed using a new load-transfer algorithm. RESULTS: Custom-made insoles significantly reduced peak pressures and force-time integrals in the heel and first metatarsal head regions; pressures and integrals were significantly increased in the medial midfoot region compared with flat insoles. Custom-made insoles successfully reduced pressures in and integrals at the first metatarsal head in 7/21 feet, were moderately successful in another seven, but failed in the remaining seven. Load transfer was greatest from the lateral heel to the medial midfoot regions. CONCLUSIONS: Custom-made insoles were more effective than flat insoles in off-loading the first metatarsal head region, but with considerable variability between individuals. Most off-loading occurred in the heel (not a region typically at risk). The load transfer algorithm effectively analyses custom-made-insole action. RELEVANCE: Because similar insole modifications apparently exert different effects in different patients, a comprehensive evaluation of custom designs using in-shoe pressure measurement should ideally be conducted before dispensing insoles to diabetic patients with neuropathy and foot deformity.

Single stage correction with external fixation of the ulcerated foot in individuals with Charcot neuroarthropathy.

The ulcerated foot in individuals with Charcot neuroarthropathy presents a complex problem when correction of the deformity is necessary but the presence of infection precludes the use of internal fixation. We reviewed 11 patients with midfoot Charcot neuroarthropathy, collapse, and ulceration who were at risk for amputation. These patients underwent operative debridement, corrective osteotomy, external skeletal fixation and culture-directed antibiotic therapy as a limb salvage procedure. Patients were transitioned from the external fixator (average 57 days) to total contact casting (average 131 days) and all subsequently progressed to therapeutic footwear in 12 to 49 months of follow-up (average 24 months), except one patient whose medical decline resulted in bedrest. We believe that when performed in properly selected patients, this procedure presents an alternative to amputation and, via corrective osteotomy, results in a shoe-able, functional foot that is potentially less prone to ulceration.