Momentary Partner Involvement in Diabetes Self-Care and Continuously Measured Glucose: A Dynamic Analysis.

OBJECTIVE: This study examined the dynamic, real-time associations between partner involvement in diabetes self-care and continuous glucose monitor (CGM) metrics in adults with type 2 diabetes. METHODS: For 1 week, 63 participants wore Dexcom G4 CGMs and provided momentary reports of partner involvement in diabetes self-care five times per day. Dynamic structural equation models were used to estimate the reciprocal lagged effects of partner involvement on next-hour CGM metrics (and vice versa). RESULTS: Partner involvement predicted improved next-hour glucose control for five of six CGM metrics in analyses adjusted for time-varying covariates. The hour after partner involvement, the model predicted a 26.34 mg/dl decrease in glucose level (standardized ß = -0.19), 30% greater odds of meeting target time in target range ( ß = 0.07), 48% higher odds of target time below target range (TBR; ß = 0.04; the only nonsignificant effect), 47% greater odds of target time above target range (ß = 0.11), a 4.20 unit decrease in glucose standard deviation ( ß = -0.19), and a 0.01 unit decrease in glucose coefficient of variation ( ß = -0.08; all p values < .05). There was less consistent support for the reverse pathway, with only two metrics significantly related to next-hour partner involvement: glucose level ( ß = 0.15) and TBR ( ß = 0.21), such that having higher levels and meeting target TBR were significantly predictive of next-hour partner involvement. CONCLUSIONS: This is the first study showing that partner involvement in daily diabetes management predicts short-term glucose control. More research is needed to understand how partners influence glycemic control and evaluate interventions that promote their involvement in diabetes care.

Effect of parathyroidectomy on osteopontin and undercarboxylated osteocalcin in patients with primary hyperparathyroidism.

PURPOSE: Surgical treatment for primary hyperparathyroidism (PHPT) improves bone metabolism. Osteocalcin (OC) and its undercarboxylated form (ucOC) are associated with bone and energy metabolism. Osteopontin (OPN), a multifunctional protein expressed in bone, is involved in resorption, along with ß-carboxyl-terminal cross-linking telopeptide of type 1 collagen (ß-CTX), and osteoprotegerin (OPG). Our aim was to investigate these biomarkers of bone metabolism in patients with PHPT. METHODS: We examined 30 individuals with PHPT, in a clinical research facility, before and 1 month following parathyroidectomy. Circulating levels of OC, ucOC, OPN, ß-CTX, and OPG were examined as bone biomarkers along with inflammatory markers (e.g., interleukin-6 [IL-6], lipocalin-2), insulin resistance (i.e., homeostasis model assessment for insulin resistance [HOMA-IR]), adiposity (i.e., leptin, adiponectin), PTH, calcium, 25-hydroxyvitamin D, creatinine, and demographics. RESULTS: Participants (27 females/3 males) were 60 ± 9 (mean±SD) years old. There was a significant reduction of ucOC (7.9 ± 5.1 [median±SIQR] vs. 6.6 ± 3.7 ng/mL, p = 0.022) and OPN (75.4 ± 14.5 vs. 54.5 ± 9.2 ng/mL, p < 0.001) pre- versus post-parathyroidectomy. There were no univariate differences postoperatively for IL-6, HOMA-IR, leptin, or adiponectin. Regression analysis showed that postoperative levels of adiponectin, IL-6, and OPN were significantly associated with ucOC, while adjusting for PTH and albumin corrected calcium levels (model R2 = 0.610, p = 0.001). With OPN as the dependent variable, higher adiponectin and lower ucOC were significantly associated with lower OPN levels postoperatively (model R2 = 0.505, p = 0.010). CONCLUSION: The lower 1-month postoperative OPN and ucOC levels in PHPT seem to indicate reduced bone resorption. Decreased ucOC levels may also suggest lower energy demands postoperatively.

Osteopontin and clusterin levels in type 2 diabetes mellitus: differential association with peripheral autonomic nerve function.

Osteopontin (OPN) and clusterin are secreted glycoproteins potentially associated with nerve function. Sudomotor dysfunction is associated with the development of foot ulcerations. The purpose of this study was to investigate the potential relationship of OPN and clusterin with sudomotor function (i.e., autonomic nerves that control sweating) in participants with type 2 diabetes mellitus (T2DM). Sudomotor function was assessed using SUDOSCAN® which measures electrochemical skin conductance (ESC) of the hands and feet. Demographics (e.g., age, gender, race, body mass index (BMI)), HbA1c, 25-hydroxyvitamin D, creatinine, OPN, and clusterin were also determined for the participants. Fifty individuals with T2DM (age = 59±11 years; 23/27 male/female; 13 African Americans) participated in this study. Lower ESC for the hands and feet were observed in African Americans versus Caucasians/Asians (p < 0.05). No significant ESC differences were observed for good [HbA1c <7%] versus poor [HbA1c ≥7%] glycemic control. With regard to gender, ESC values were lower for the hands for females (p < 0.05). In linear regression with ESC for the hands or feet as the dependent variable, increased OPN levels, but not clusterin, were independently associated with reduced sudomotor function while adjusting for age, gender, race, BMI, and glycemic control (ESC hands model R 2 = 0.504, p < 0.001; ESC feet model R 2 = 0.534, p < 0.001). The association between OPN and reduced sudomotor function found in our study warrants further investigation to delineate the underlying mechanisms and determine if OPN is neuroprotective, involved in the pathogenesis of sudomotor dysfunction, or simply a bystander.

A Uniform Approach in the Use of U-500 Regular Insulin in the Management Of Patients with Obesity and Insulin Resistance: The Clinician's View.

BACKGROUND: As patients with diabetes continue to have greater problems with obesity, the need for more medications and higher doses of insulin has increased. Some patients are so insulin resistant that they require U-500 insulin. QUESTIONS/PURPOSES: All insulins carry the risk of hypoglycemia. Despite being the most potent insulin available, the methodology for describing U-500 insulin administration varies. This paper examines the properties of U-500 insulin and suggests a unified method of defining how it is administered. METHODS: A literature search for English language articles that reference U-500 insulin was performed. The 51 articles, and additional websites as applicable, were independently reviewed. RESULTS: Now that U-500 insulin has a specific syringe and a pen, all patients who use this should be converted to one of these two devices. The insulin dose should be described as the number of units administered. CONCLUSION: U-500 insulin is a potent formulation and carries the risk of hypoglycemia. A unified method of administration is now available, and the description of its use should reflect the number of units administered.

Vitamin D Insufficiency is Associated with Reduced Parasympathetic Nerve Fiber Function in Type 2 Diabetes.

OBJECTIVE: Vitamin D insufficiency is prevalent in subjects with type 2 diabetes mellitus (T2DM) and is associated with peripheral neuropathy. However, there are little data regarding vitamin D status in patients with cardiovascular autonomic neuropathy. Our objective was to evaluate the association of cardiovascular autonomic function, 25-hydroxyvitamin D (25[OH]D) insufficiency (i.e., levels <30 ng/mL), and multiple metabolic parameters in subjects with T2DM. METHODS: We examined 50 individuals with T2DM. Cardiovascular autonomic function (i.e., parasympathetic function) was assessed by RR-variation during deep breathing (i.e., mean circular resultant [MCR] and expiration/inspiration [E/I] ratio). Metabolic parameters included measures of adiposity, glycemic control, insulin resistance, calcium metabolism, and 25(OH)D. RESULTS: Participants with 25(OH)D insufficiency (n = 26) were younger (66 ± 9 vs. 60 ± 10 years, P<.05), more insulin resistant, had a higher body mass index (BMI) and lower adiponectin levels. The MCR (39.5 ± 26.3 vs. 27.6 ± 17.2, P<.01) and E/I ratio (1.21 ± 0.17 vs. 1.15 ± 0.09, P<.01) were lower for those with 25(OH)D insufficiency after controlling for age. A stepwise selection procedure regressing MCR and E/I ratio on a number of metabolic parameters resulted in a model identifying age and 25(OH)D insufficiency as significant determinants for both measures. The interaction of age x 25(OH)D insufficiency was also included (MCR model, R2 = 0.491, P<.001; E/I ratio, R2 = 0.455, P<.001). Neither glycemic control nor other metabolic parameters were selected. CONCLUSION: Our results suggest that 25(OH)D insufficiency is associated with reduced parasympathetic function, with a stronger association in younger persons with T2DM. Studies are needed to determine if vitamin D supplementation into the sufficient range could prevent or delay the onset of cardiovascular autonomic dysfunction.

Osteoprotegerin is a Better Serum Biomarker of Coronary Artery Calcification than Osteocalcin in Type 2 Diabetes.

OBJECTIVE: Coronary artery calcification (CAC) is a prominent feature of atherosclerosis and is associated with cardiovascular events. In vitro studies have suggested that osteoprotegerin (OPG) and osteocalcin (OC) exert anticalcification potential in the vessel wall. The objective of this study was to investigate the association of CAC and serum bone biomarkers in persons with type 2 diabetes. METHODS: We examined 50 individuals with type 2 diabetes. CAC imaging was performed by multidetector computed tomography. CAC scores ≥10, expressed in Agatston units, were considered abnormal. OC, undercarboxylated OC (ucOC), and OPG levels were determined by enzyme-linked immunosorbent assay. RESULTS: Abnormal CAC scores were found for 64% of the study cohort. OPG levels were significantly elevated (5.5 ± 2.0 pmol/L vs. 4.2 ± 1.7 pmol/L; P = .026) for those with abnormal CAC scores. No univariate differences were found for OC or ucOC. Logistic regression analyses revealed that an increase in serum OPG level was significantly associated with an increase in CAC score (odds ratio, 3.324; 95% confidence interval, 1.321 to 8.359; P = .011). Longer duration of diabetes was a significant covariate (P = .026), whereas nonsignificant covariates in the final model were age, gender, systolic blood pressure, body mass index, insulin resistance determined by the homeostasis model assessment for insulin resistance, leptin, adiponectin, and glycemic control. The Nagelkerke R2 for the model was 0.66. Neither OC nor ucOC were significantly associated with elevated CAC scores. CONCLUSION: Our results suggest that OPG is a more useful serum biomarker than OC or ucOC for identifying those at increased risk of arterial calcification in type 2 diabetes.

Neighborhood Environment and Poor Maternal Glycemic Control-Associated Complications of Gestational Diabetes Mellitus.

Introduction: Risk of complications due to gestational diabetes mellitus is increasing in the U.S., particularly among individuals from racial minorities. Research has focused largely on clinical interventions to prevent complications, rarely on individuals' residential environments. This retrospective cohort study aims to examine the association between individuals' neighborhoods and complications of gestational diabetes mellitus. Methods: Demographic and clinical data were extracted from electronic health records and linked to American Community Survey data from the U.S. Census Bureau for 2,047 individuals who had 2,164 deliveries in 2014-2018. Data were analyzed in 2021-2022 using Wilcoxon rank sum test and chi-square test for bivariate analyses and logistic regression for analysis of independent effects. All census tract-based variables used in the model were dichotomized at the median. Results: Bivariate analysis showed that the average percentage of adults earning <$35,000 was higher in neighborhoods where individuals with complications were living than in neighborhoods where individuals without complications were living (30.40%±12.05 vs 28.94%±11.71, p=0.0145). Individuals who lived in areas with ≥8.9% of residents aged >25 years with less than high school diploma had a higher likelihood of complications than those who lived in areas with <8.9% of such residents (33.43% vs 29.02%, p=0.0272). Individuals who lived in neighborhoods that had ≥1.8% of households receiving public assistance were more likely to have complications than those who lived in areas where <1.8% of households received public assistance (33.33% vs 28.97%, p=0.0287). Logistic regression revealed that the odds of deliveries with complications were 44% higher for individuals with obesity (OR=1.44; 95% CI=1.17, 1.77), 35% greater for individuals residing in neighborhoods with higher percentages of households living below the poverty level (OR=1.35; 95% CI=1.09, 1.66), and 28% lower for individuals from neighborhoods where a higher percentage of households had no vehicles available for transportation to work (OR=0.72; 95% CI=0.59, 0.89). Conclusions: Clinical interventions in concert with environmental changes could contribute to preventing maternal and neonatal complications of gestational diabetes mellitus.

Romantic relationships and type 2 diabetes: The role of invisible social control.

OBJECTIVE: This study aimed to determine whether invisible social control provided by a romantic partner is associated with improved objective glucose outcomes for patients with Type 2 diabetes. Social control reflects a partner's attempt to modify or influence a patient's health behaviors. We hypothesized that the best outcome for all continuous glucose monitoring measures would be captured by an interaction condition reflecting invisible social control. METHOD: Patients with Type 2 diabetes and their partners (N = 63 couples) completed an 8-day daily diary period between 2016 and 2017. Self-report measures of social control receipt and provision were obtained each evening from patients and partners and patients wore a continuous glucose monitor throughout the diary period. Outcomes of daily glucose mean, standard deviation, time in range, and coefficient of variation were computed and two-way interactions between social control receipt and social control provision were probed and plotted. RESULTS: The two-way interaction significantly predicted daily glucose mean, standard deviation, and time in range, such that when patients reported no social control receipt, but partners reported social control provision, patients showed improvements in objective glucose measures. We found no significant effect for coefficient of variation. CONCLUSIONS: This study was the first to use an invisible social control framework to examine the daily dyadic associations between partner social control provision, patient social control receipt, and four objectively measured continuous glucose monitoring outcomes. Findings suggest that the visibility of social control provided by a romantic partner may be predictive of glycemic control in patients with Type 2 diabetes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Screening blood donors for diabetes: analysis of use, accuracy, and cost.

BACKGROUND: The objective was to determine if a free, voluntary diabetes screening program as a part of the blood donation process might be cost-effective. STUDY DESIGN AND METHODS: During the first 6 months of the program, 26,415 donors were screened using a single random plasma glucose (RPG) level. All donors were asked to eat before donation. Low-, moderate-, and high-risk groups were formed based on RPG levels (<140, 140-200, and >200 mg/dL). Contact with a telephone questionnaire was made with 139 of 178 (78%) of the persons in the high-risk group with 33 new cases of diabetes diagnosed by the donor's physician and 26 donors indicating that they were not diagnosed with diabetes. Sex- and age-matched donors in the low- and moderate-risk groups were contacted and administered the same questionnaire. RESULTS: The three risk groups were similar, except for body mass index (28.1 ± 5.4 kg/m2 vs. 29.9 ± 5.5 kg/m2 vs. 32.7 ± 5.6 kg/m2 , p < 0.001). The discriminative effectiveness of screening was evaluated by the area under the receiver operating characteristics (AROC) curve. The AROC curve was 0.950 (95% confidence interval, 0.920-0.979) for the identification of diabetes. Using a RPG cutoff of 200 mg/dL, sensitivity was 100%, specificity was 82%, and positive predictive value was 56%. Cost analyses showed that the mean cost to screen, per donor, was less than $1. Cost per case identified was estimated to be less than $500 for a RPG cutoff of 200 mg/dL. CONCLUSIONS: Screening during the blood donation process appears to be accurate, convenient, and inexpensive.

Direct renin inhibition improves parasympathetic function in diabetes.

AIM: The renin-angiotensin-aldosterone system (RAAS) and autonomic nervous system regulate the cardiovascular system. Blockade of the RAAS may slow the progression of end-organ damage. Direct renin inhibition offers a means for blocking the RAAS. The objective of this study was to examine the effect of direct renin inhibition on cardiovascular autonomic function. METHODS: In this double-blind, placebo-controlled trial, 60 individuals with diabetes were randomly assigned to 300 mg of aliskiren or placebo once daily for 6 weeks. The primary end point was a change in tests of cardiovascular autonomic function. Autonomic function was assessed by power spectral analysis and RR-variation during deep breathing [i.e. mean circular resultant (MCR), expiration/inspiration (E/I) ratio]. The MCR and E/I ratio assess parasympathetic function. Secondary measures included change in biochemical parameters [e.g. plasma renin activity, leptin and interleukin-6]. Change in cardiovascular autonomic function and blood analytes were analysed by a mixed effects model for repeated measures. RESULTS: Baseline characteristics were similar between treatment groups. In response to aliskiren compared with placebo, blood pressure was reduced as well as plasma renin activity [from 2.4 ± 3.8 (mean ± standard deviation) to 0.5 ± 0.4 µg/l/h, p < 0.001]. There was a significant interaction (aliskiren × visit) for MCR (p = 0.003) and E/I ratio (p = 0.003) indicating improvement in MCR and E/I ratio for those on aliskiren. MCR means, baseline vs. follow-up, were 41.8 ± 19.7 vs. 50.8 ± 26.1 (aliskiren) and 38.2 ± 23.6 vs. 37.5 ± 24.1 (placebo). CONCLUSIONS: Parasympathetic function (i.e. MCR and E/I ratio) was enhanced by downregulation of the RAAS.

Hip strength in adults with type 1 diabetes is associated with age at onset of diabetes.

We investigated the association of age at onset of type 1 diabetes with areal bone mineral density (aBMD), estimates of bone strength, and outer diameter. Using dual-energy X-ray absorptiometry (DXA), aBMD, axial strength (cross-sectional area [CSA]), bending strength (section modulus [SM]), and outer diameter at the narrow neck, intertrochanter, and shaft of the proximal femur were determined for 60 adults. Analysis of covariance (ANCOVA) was used to determine if the DXA-based measures of bone were related to age at onset and if this relationship differed by gender. Age at onset, gender, and the interaction of age at onset by gender were included in the ANCOVA models along with current age, duration, height, lean soft tissue mass, and hemoglobin A1c as covariates. In the adjusted models with CSA, SM, or outer diameter as the dependent variable, age at onset (p<0.01) and gender (p<0.0001) were significant with no interaction. For shaft aBMD, there was a significant age at onset by gender interaction (p=0.0285), where an earlier onset was associated with lower aBMD in the femoral shaft of females but not males. The findings suggest that an earlier onset of type 1 diabetes is associated with lower measures of bone strength and outer diameter.

The use of porcine acellular dermal matrix in silicone implant-based breast reconstruction.

INTRODUCTION: The most frequently occurring long-term complication in implant-based breast reconstruction is fibrotic capsule formation at the recipient site, with concurrent dysesthesia and poor aesthetic results. Using porcine acellular dermal matrix (PADM) as a connective tissue graft material is supposed to improve the quality and quantity of soft tissue in implant-based breast reconstruction. This study investigates the indications for and the results and the costs of using PADM for the correction or prevention of implant-associated breast deformities. MATERIALS AND METHODS: This study reviewed a single surgeon's experience in the correction or prevention of implant-associated breast deformities with PADM in breast cancer-related breast reconstruction from 2009 to 2011. A total of 23 patients (27 breasts) were included in the study. The aesthetic outcome, the incidence and the type of complication were analysed. Twenty-three women underwent breast cancer-related breast reconstruction: 19 women underwent single-breast reconstruction and four women underwent bilateral reconstruction. RESULTS: Of the 23 patients who underwent breast reconstruction, 18 (78%) were "satisfied" with the aesthetic and haptic outcome after implant-based reconstruction with PADM. One patient (one breast) required another breast operation because of ipsilateral breast cancer recurrence during the follow-up period. PADM-assisted implant-based breast reconstruction has a satisfactory safety profile. CONCLUSION: The use of PADM as an interface matrix for implant-based breast reconstruction yielded predictable and acceptable aesthetic and haptic results by preventing capsular contracture, rippling, implant malposition, soft-tissue thinning and failure of the silicone implant-based breast augmentation.

PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel ± darbepoetin alfa in primary breast cancer--results at the time of surgery.

BACKGROUND: Preoperative chemotherapy is a recommended treatment of both primary operable and locally advanced breast cancer. Strategies to improve efficacy include the use of anthracyclines, taxanes, and intensified dose with bone marrow support. PATIENTS AND METHODS: Patients received neoadjuvant epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) followed by paclitaxel 175 mg/m(2) (EC→T), each 3-weekly for four cycles (n = 370), or epirubicin 150 mg/m(2) followed by paclitaxel 225 mg/m(2) with pegfilgrastim followed by CMF (cyclophosphamide 500 mg/m(2), methotrexate 40 mg/m(2), fluorouracil 600 mg/m(2)) on days 1 and 8 (E(dd)→T(dd)→CMF), each 2-weekly and for three cycles (n = 363). Patients were randomly allocated to either simultaneous darbepoetin alfa (DA) (n = 356) or none (n = 377). RESULTS: Pathological complete response (pCR) rate (breast) was higher with E(dd)→T(dd)→CMF, 18.7% versus 13.2% with EC→T; P = 0.043, ypT0/Tis; ypN0 was reported in 20.9% versus 14.3% respectively; P = 0.019. Patients with grade 3 tumors and negative hormone receptor status had a significantly higher pCR rate. Mean hemoglobin values maintained higher with DA (13.6 versus 12.6 g/dl). E(dd)→T(dd)→CMF regimen showed more grade 3-4 mucositis, sensory neuropathy, and neurological complaints. Thromboembolic events were more frequent on DA (3% versus 6%; P = 0.055). CONCLUSION: Dose-dense and -intensified neoadjuvant chemotherapy with E(dd)→T(dd)→CMF was potentially superior to EC→T in terms of pCR. Primary use of DA did not affect pCR.

PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel, and CMF versus a standard-dosed epirubicin-cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer--outcome on prognosis.

BACKGROUND: The objective of this study was to compare the effect of dose-intensified neoadjuvant chemotherapy with that of standard epirubicin plus cyclophosphamide followed by paclitaxel in combination with or without darbepoetin on survival in primary breast cancer. PATIENTS AND METHODS: A total of 733 patients received either four cycles of neoadjuvant epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks followed by four cycles of paclitaxel 175 mg/m(2) every 3 weeks (EC→T), or three cycles of epirubicin 150 mg/m(2) every 2 weeks followed by three cycles of paclitaxel 225 mg/m(2) every 2 weeks followed by three cycles of combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (E(dd)→T(dd)→CMF). The patients were randomly assigned to receive darbepoetin or none. The primary objective was to demonstrate a superior disease-free survival (DFS) of E(dd)→T(dd)→CMF compared with EC→T. RESULTS: Estimated 3-year DFS was 75.8% with EC→T versus 78.8% with E(dd)→T(dd)→CMF [hazard ratio (HR) 1.14; P = 0.37] and overall survival (OS) 88.4% versus 91.5% (HR 1.26; P = 0.237). Three-year DFS was 74.3% with darbepoetin versus 80.0% without (HR 1.31; P = 0.061) and OS 88.0% versus 91.8% (HR 1.33; P = 0.139). Patients with a pathologically documented complete response [pathological complete response (pCR)] had a significantly better DFS compared with those without achieving a pCR (estimated 3-year DFS: 89.2% versus 74.9%; HR 2.27; P = 0.001). CONCLUSION: Neoadjuvant dose-intensified chemotherapy compared with standard chemotherapy did not improve DFS, whereas the addition of darbepoetin might have detrimental effects on DFS.

Off-label use in Germany - a current appraisal of gynaecologic university departments.

OBJECTIVE: The off-label use, referring to the applicability of pharmaceutical drugs beyond the submitted and from the Federal Institute for Drugs and Medical Devices (BfArM, Bundesamt für Arzneimittel und Medizinprodukte) certified and approved administration, is the subject of controversial discussions. The application can be considered in case of severe illness - if no therapeutic alternatives are available - or it exists as a founded perspective for achieving therapeutic success. METHODS: A latitudinal study for evaluating the application of off-label use supplements was performed at 43 German university and academic teaching hospitals. Five doctors at each hospital applied off-label pharmaceutical drugs and were called upon to share their personal experience to the application of those medications. RESULTS: 75 (35%) questionnaires were returned out of 22 (51%) medical centres with 215 contacted physicians. Off-label use was common for 65 (91%) of the physicians. Only 9% of them obviate the application of off-label drugs. About a half of the medication is related to application in obstetrics (54%) and in most cases on an every day basis. Uterotonics were the most commonly used off-label medications (34%). The main part of information about off-label use is obtained from personal information of colleagues (66%) and personal experience (58%). 34% of physicians think that off label use is risky. Interestingly, the view about off label use of medication varies considerably among physicians from various hospitals. CONCLUSIONS: The application of off-label pharmaceutical drugs in Germany seems to be a well established practice. More than 90% of participators of our trial use at least one medication outside the administration. This includes particularly prostaglandins, anti-hypertonic therapeutics and chemotherapeutics.

Supraclavicular lymph node metastases of unknown origin: HPV-typing identifies the primary tumour.

Cancers of unknown primary origin (CUP) account for 0.5-10% of all malignancies. CUP patients with metastases have a median survival of approximately 6 months, despite therapy. Identification of the primary tumour site may offer the opportunity of a specific and more efficient treatment. The case of a 45-year-old woman with supraclavicular lymph node metastases of a squamous cell CUP is reported. A staging laparoscopy with multiple biopsies and a loop diathermy excision of the cervix were performed. Human papillomavirus (HPV)-testing in the tissues revealed the tumour cells as metastases of an occult cervical cancer. Primary platin-based chemotherapy combined with paclitaxel leads to a complete apparative remission. Twelve months later, staging positron emission tomography with 2-[18F]fluoro-2-deoxy-D-glucose in combination with computed tomography identified an isolated left renal lymph node metastasis. The patient received targeted radiation therapy, combined with cisplatin. To date, 19 months after diagnosis, she is doing well without any evidence of disease. The presented case report addresses the difficulties involving the identification of CUP. HPV-DNA is found in over 95% of cervical cancers. As the presented case illustrates, testing for this virus DNA in human tissues can be a useful diagnostic tool in patients with CUP where cervical cancer is the possible primary tumour.

[An unusual breast tumor]. / Ein ungewöhnlicher Mammatumor.

The presented case shows how difficult it can be to diagnose rare diseases if they present with masses in atypical locations. In an extensive further diagnostic workup other characteristic findings then point to the correct diagnosis.

Continuous positive airway pressure therapy improves cardiovascular autonomic function for persons with sleep-disordered breathing.

BACKGROUND: Sleep-disordered breathing (SDB) is an independent risk factor for cardiovascular morbidity. Dysfunction of the cardiovascular autonomic nervous system may be a potential mechanism whereby SDB is linked to cardiovascular disease. Repetitive sympathetic activation during apneic episodes may impair cardiovascular reflex function, and increased sympathetic activity can stimulate renin release. Given that patients with SDB may have reduced cardiovascular autonomic function, the purpose of this study was to determine whether treatment with continuous positive airway pressure (CPAP) for 6 weeks would improve autonomic function. METHODS: Twenty-nine participants with a diagnosis of SDB, who completed 6 weeks of CPAP therapy, were evaluated for cardiovascular autonomic nerve fiber function at baseline and post therapy. Autonomic function tests included the following: R-R interval variation during deep breathing measured by vector analysis (ie, mean circular resultant [MCR]) and expiration/inspiration (E/I) ratio; and the Valsalva maneuver. Participants were also evaluated prior to CPAP therapy for plasma renin activity levels. RESULTS: Participants in this study showed improved cardiovascular autonomic function after 6 weeks of treatment (baseline vs follow-up) as assessed by the mean (+/- SD) MCR (33.2 +/- 22.5 vs 36.9 +/- 24.2, respectively; p < 0.05) and E/I ratio (1.20 +/- 0.12 vs 1.24 +/- 0.14, respectively; p < 0.01). Improved vagal tone was also noted for subjects with elevated renin levels. CONCLUSIONS: Treatment of SDB with CPAP for 6 weeks improved vagal tone and may be beneficial in reducing the risk of developing clinical manifestations of cardiovascular autonomic dysfunction (eg, increased risk of mortality).

Adherence to outpatient program postoperative appointments after bariatric surgery.

BACKGROUND: Surgery is the only treatment that has been proved to have beneficial long-term effects for the morbidly obese (body mass index >40 kg/m(2)). One of the requirements for the Centers for Excellence program instituted by American Society for Bariatric Surgery is to have a system in place to provide comprehensive follow-up care. A recent study showed that the complication rate after bariatric surgery is 39.6% during the 180 days after discharge. Inadequate adherence to follow-up care has been recognized as contributory to the development of complications after bariatric surgery. The purpose of this study was to examine the variables that relate to patients' adherence to scheduled appointments after bariatric surgery. METHODS: A block entry logistic regression analysis was done from a database of an outpatient bariatric program that contained cross-sectional data collected for 1 year. Patient adherence to follow-up was defined as having 1 postoperative follow-up appointment within 90 days of undergoing surgery. A total of 375 subjects completed the preoperative program and underwent either laparoscopic Roux-en-Y gastric bypass (84.3%) or gastric banding (15.7%). RESULTS: Of the 14 variables used in the analysis, 5 were statistically significant (P <.05) predictors of adherence: age, body mass index, marital status, employment status, and insurance coverage. CONCLUSION: Incorporation of the identified predictors into preoperative screening tools to flag patients at risk of nonadherence might improve follow-up care. Additional research is needed on possible interventions to decrease complications after bariatric surgery.