Leszek Czupryniak

Randomized clinical trial of postoperative hernia prophylaxis in open bariatric surgery.

Postoperative hernia following bariatric procedures is more common than in other groups of surgical patients, and remains a serious problem. Gastric bypass is the most often performed bariatric procedure and, despite the increasing popularity of a laparoscopic approach, many morbidly obese patients are still offered open procedures. The aim of this study was to assess the effects of prophylactic polypropylene mesh in morbidly obese patients undergoing gastric by‐pass surgery.

The use of polypropylene mesh in midline incision closure following gastric by-pass surgery reduces the risk of postoperative hernia

Abstract Background. Incisional hernia is a common problem following Roux-en-Y gastric bypass for morbid obesity. Patients and materials. We report the preliminary results of nonrandomized prophylactic use of polypropylene mesh in a group of 60 consecutive patients. The patients with highest body mass index, and/or history of abdominal hernias and profound liver damage had abdominal wall reinforced with mesh during an operation. A year later the wound was assessed in all patients. Results. In standard wound closure group (n=48) incisional hernia was found in 9 cases (20%). None of the patients with inserted mesh (n=12) developed hernia. The length of hospital stay in mesh group was similar to that in the nonmesh group and shorter than in patients with hernia occurrence. Mesh insertion was complicated with wound discharge in three patients. Conclusions. In our opinion prophylactic use of polypropylene mesh in bariatric patients is highly effective in postoperative hernia prevention.

Concordance between fasting and 2-h post-glucose challenge criteria for the diagnosis of diabetes mellitus and glucose intolerance in high risk individuals.

SUMMARY

Self-Monitoring of Blood Glucose in Diabetes: From Evidence to Clinical Reality in Central and Eastern Europe—Recommendations from the International Central-Eastern European Expert Group

Self-monitoring of blood glucose (SMBG) is universally considered to be an integral part of type 1 diabetes management and crucial for optimizing the safety and efficacy of complex insulin regimens. This extends to type 2 diabetes patients on intensive insulin therapy, and there is also a growing body of evidence suggesting that structured SMBG is beneficial for all type 2 diabetes patients, regardless of therapy. However, access to SMBG can be limited in many countries in Central and Eastern Europe. A consensus group of diabetes experts from 10 countries in this region (with overlapping historical, political, and social environments)--Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, Slovakia, Slovenia, and Ukraine--was formed to discuss the role of SMBG across the spectrum of patients with diabetes. The group considered SMBG to be an essential tool that should be accessible to all patients with diabetes, including those with non-insulin-treated type 2 diabetes. The current article summarizes the evidence put forward by the consensus group and provides their recommendations for the appropriate use of SMBG as part of individualized patient management. The ultimate goal of these evidence-based recommendations is to help patients and providers in Central and Eastern Europe to make optimal use of SMBG in order to maximize the efficacy and safety of glucose-lowering therapies, to prevent complications, and to empower the patient to play a more active role in the management of their diabetes.

Hand exercise test for the assessment of endothelium-dependent vasodilatation in subjects with type 1 diabetes.

BACKGROUND At present, endothelial dysfunction is best assessed in vivo with measurement of flow-mediated dilatation (FMD) with Doppler ultrasound scanning. This test, however, does not account for the subjects age and is uncomfortable for patients. The aim of the study was to compare a new test for endothelium function assessment using hand exercise load. METHODS The study group comprised 31 male patients with type 1 diabetes and 72 healthy men as controls. The subjects in both groups were subdivided into three age groups: 18-30 (subgroup A), 31-45 (subgroup B), and 46-60 (subgroup C) years. FMD of the brachial artery with induction of hand ischemia was conducted in all the subjects. Afterwards, an originally designed test using standardized hand exercise with the use of a training device was performed. RESULTS In the youngest group of type 1 diabetes patients the effect of hand ischemia on brachial artery diameter was greater than in the two older age subgroups: baseline artery diameter increased by 0.23 +/- 0.11 mm (5.7%), 0.19 +/- 0.09 mm (4.3%), and 0.13 +/- 0.02 mm (2.8%), respectively (P < 0.01). In the hand exercise test, artery diameter increased in the youngest subjects by 0.39 +/- 0.11 mm (9.5%) and in the two older groups by 0.26 +/- 0.07 mm (5.6%) and 0.18 +/- 0.09 mm (4.5%) (P < 0.05), respectively. In subgroups A, B and C, vasodilation after hand exercise test was greater by 67%, 30%, and 32% (P < 0.01), respectively, compared with the effect of the ischemic test. In the controls similar effects and relationship between ischemic and hand exercise tests were noted, however, with a smaller difference between the two tests. CONCLUSIONS The hand exercise test results in a greater difference in vessel diameter before and after the test stimulus, which might substantially improve its feasibility. The hand exercise test could be a useful alternative tool for endothelial function assessment, especially in type 1 diabetes subjects.

Mild Elevation of Fasting Plasma Glucose is a Strong Risk Factor for Postoperative Complications in Gastric Bypass Patients

Background: Bariatric surgery may be associated with surgical complications. The aim of the study was to identify significant risk factors for postoperative complications in patients undergoing Roux-en-Y gastric bypass (RYGBP). Methods: The study consisted of 75 consecutive patients undergoing RYGBP. Full medical examination was performed, and the following parameters were assessed in the fasting state: plasma glucose, insulin, leptin, serum lipids, liver function tests, and lipoprotein Lp(a). All subjects had oral 75 g glucose tolerance test before the surgery. All complications occurring within 6 months after the RYGBP were recorded. The patients were divided into Group 1 - patients in whom complications occurred, and Group 2 - patients with no complications in the 6-month period. Results: Postoperative complications occurred in 16 patients (wound infection, hernia, splenic injury, gastro-jejunal obstruction, duodenal ulcer, lower limb deep vein thrombosis). 3 significant risk factors for postoperative complications within 6 months after gastric bypass were found: 1) fasting plasma glucose ≥ 6.0 mmol/l (OR 11.0; 95% confidence interval (CI) 2.1-77.3), 2) age ≥40 years (OR 5.89, 95% CI 1.35-29.4), and 3) BMI ≥45 kg/m2 (OR 4.1, 95% CI 1.04-17.2). Conclusion: RYGBP is associated with increased risk of developing early postoperative complications in subjects with even slightly elevated fasting plasma glucose, age ≥40 and BMI ≥45 kg/m2.

Diabetes screening after gestational diabetes mellitus: poor performance of fasting plasma glucose

Abstract.Gestational diabetes mellitus (GDM) is an established risk factor for the development of overt diabetes. Since the change in diagnostic criteria for diabetes in 1997, it is unclear whether there should be any preference for fasting or post-glucose challenge blood glucose in diagnosing diabetes after GDM. The study aimed at assessing the usefulness of both diagnostic methods in women after GDM. The study enrolled 193 women with previous GDM. Women who did not have a current diagnosis of diabetes were screened for impaired fasting glucose (IFG) and for glucose intolerance with an oral 75-g glucose tolerance test. A total of 45 (23.3%) subjects declared to be already diabetic. Of the 148 non-diabetic subjects, 141 (95.3%) had normal fasting plasma glucose, whereas four (2.8%) had IFG (i.e. FPG≥6.1 and <7.0 mmol/l) and 3 (2.5%) had FPG≥7.0 mmol/l. Upon OGTT, among the 141 subjects with normal FPG, 6 (4.3%) were diagnosed with diabetes and 23 (16.3%) with impaired glucose tolerance (IGT); the remaining 112 (79.5%) had normal glucose tolerance. Three out of four subjects with IFG had IGT. The sensitivities of fasting criteria for diagnosis of diabetes and IFG/IGT were 14.3% (95% CI, 8.0%–37.2%) and 17.1% (95% CI, 8.6%–19.8%), respectively. The specificities were 98.6% (95% CI, 97.9%–99.7%) and 99.1% (95% CI, 96.5%–100%), respectively. The kappa for diabetes diagnosis was 0.177 (95% CI, 0.018–0.507). For women with previous GDM, the sensitivity of the new criteria based upon fasting plasma glucose is unacceptably low. In addition, the two sets of criteria are not interchangeable. Therefore, we suggest full glucose tolerance diagnostic procedures in women after GDM, including assessment of post-glucose challenge values.

Role of adipocytokines and its correlation with endocrine pancreatic function in patients with pancreatic cancer.

INTRODUCTION Some authors suggest that adipocytokines contribute to the induction of pancreatic carcinogenesis as well as the development of endocrine insufficiency. AIMS We evaluate the circulating concentrations of leptin, resistin and visfatin in patients with newly diagnosed pancreatic cancer (PC) and relationship between serum adipocytokines level and clinicopathological features of PC. Moreover the usefulness of those adipocytokines as possible biomarkers of endocrine pancreatic function in PC has been assessed. METHODS The pilot study group consisted of 45 individuals (mean age 65.6 ± 11.5 years, BMI 21.8 ± 3.4 kg/m(2)) with newly diagnosed PC (within last 1-3 months) and 13 healthy individuals with age, gender and BMI matched to the study group. Among PC patients 18 (40%) had recently diagnosed diabetes. Fasting plasma leptin, resistin, visfatin concentrations were determined with ELISA (R&D Systems, Phoenix Pharmaceuticals) and insulin by RIA (DakoCytomation). RESULTS Patients with PC as compared to controls had significantly lower plasma leptin (40.6 ± 21.3 vs 63.2 ± 16.3 pg/mL; p < 0,0008). In contrast PC patients showed more than six fold higher level of resistin (126.2 ± 143.2 vs 18.9 ± 7.2 ng/mL; p < 0.009) than controls. The median plasma visfatin was 2.8 ± 1.8 ng/mL, which was not significantly different from the controls (3.8 ± 1.1 ng/mL). When PC patients with and without diabetes were considered separately, plasma leptin concentrations among nondiabetic patients were slightly, but not significantly higher (44.6 ± 21.0) as compared to diabetics (34.5 ± 20.7). Moreover there was no difference between visfatin and resistin level in PC, among patients with and without diabetes. No significant differences between serum level of leptin, visfatin and resistin and age, gender, BMI, smoking status, tumor localization, distant metastases and pain has been found. CONCLUSION The results of this study confirm previous findings that patients with newly diagnosed pancreatic cancer are characterized with lower level of leptin. This pilot study showed significantly higher resistin concentrations in patients with PC in comparison to healthy controls, which may be helpful in PC early diagnosis. Changes in leptin and resistin level in PC are not likely related to endocrine disorders.

Sleep disordered breathing in REM sleep reverses the downward trend in glucose concentration

OBJECTIVE Regulation of glucose concentration depends on sleep stages with interstitial glucose concentration (IGC) declining in REM vs. stable IGC in NREM sleep. Apneas and hypopneas constituting sleep disordered breathing (SDB) are implicated in impaired glucose metabolism. Therefore, the aim of the study was to investigate whether SDB can influence IGC in REM and NREM sleep. METHODS Thirty-two patients underwent standard polysomnography with continuous glucose monitoring system (CGMS) and a morning fasting glucose measurement. Eleven subjects were eligible due to the periodic occurrence of SDB in sleep; thus the presence of REM and NREM sleep with and without SDB (REM-, NREM-no-SDB and REM-, NREM-SDB, respectively). RESULTS The IGC in REM-no-SDB declined, and its mean change was lower than that of NREM-no-SDB by almost 10-fold: -0.047±0.051 vs. -0.005±0.022 mmol/l · 5 min(-1), respectively (P=0.019, n=11). The occurrence of SDB in REM abolished this decline: 0.002±0.022 vs. -0.053±0.049 mmol/l · 5 min(-1) for REM-no-SDB (P=0.006; n=10). There was no difference between NREM-no-SDB and NREM-SDB in respect to IGC. CONCLUSION Occurrence of SDB in REM reversed the decline of IGC, while in NREM sleep SDB had no effect on IGC. SDB may affect neuro-endocrine regulations in REM sleep.

A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction with the SoloSTAR Insulin Injection Device in Type 1 and Type 2 Diabetes

Objective: This study evaluated patient satisfaction with SoloSTAR® (sanofi-aventis), a prefilled insulin pen device for injection of insulin glargine or insulin glulisine. Methods: This was a 6–8-week multicenter (n = 652), observational, prospective Pan-European and Canadian registry study in patients with diabetes mellitus (n = 6542) who recently switched to or started treatment with insulin glargine and/or insulin glulisine using SoloSTAR or were insulin naïve. At the baseline visit, patients were asked to evaluate their satisfaction with their previous device, if applicable. After 6–8 weeks of SoloSTAR use, patients were asked to rate their satisfaction. Results: Overall, 6481 patients (mean age 54 years, 48.7% male, 72% type 2 diabetes) were analyzed in this study. Of these, 4995 (77.1%) patients had used insulin before the study and 1641 (32.9%) and 3395 (68.0%) patients had previously used prefilled and/or reusable pens, respectively. During the study, SoloSTAR was used to administer insulin glargine and/or insulin glulisine by 97.3% and 36.0% of patients, respectively (both: 27.0%). Most patients rated SoloSTAR as “excellent/good” for ease of use (97.9%), learning to use (98.3%), selecting the dose (97.6%), and reading the dose (95.1%). Most patients rated ease of use (88.4%) and injecting a dose (84.5%) with SoloSTAR as “much easier/easier” versus their previous pen. Overall, 98% planned to continue using SoloSTAR. No safety concerns were reported. Conclusion: This European and Canadian survey shows that SoloSTAR was well accepted in this large patient population. Most patients preferred SoloSTAR to their previous pen and planned to continue SoloSTAR use.