Marek Buzga

Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study.

Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life. Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit. Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains. Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.ClinicalTrials.gov identifier: NCT 02802007.

Adipokines as Biomarkers in Health and Disease

Adipokines are important circulating factors mediating intertissue crosstalk throughout the body and thus playing a key role in maintaining endocrine homeostasis. So far, multiple associations of adipokines with widespread noncommunicable diseases, including cardiometabolic diseases, cancer, neurodegenerative diseases, and fertility problems, have been identified. However, the precise mechanisms underlying empirically observed associations are still rather poorly understood, and more research must be carried out in order to make sense of and deepen the already published data.

Short-term outcomes of the new intragastric balloon End-Ball® for treatment of obesity

Introduction Intragastric balloons (IGBs) have been successfully used to treat obesity for the last 18 years. These balloons are made of different materials and filled with either air or saline. It seems that balloons filled with saline result in more effective weight loss, but are associated with worse tolerance after implantation. In contrast, balloons filled with air are associated with excellent tolerance, but result in less effective weight loss. Aim To report the early safety and effectiveness results of the End-Ball® balloon and to encourage discussions on how to best use this new-generation IGB for endoscopic weight loss management. Material and methods Twenty obese patients (mean age: 40.5 years; mean body mass index: 34.8 kg/m2) were included in a 6-month study. Balloons were inflated with 300 ml of saline containing 5 ml of methylene blue and 300 cm3 of air. Results No serious adverse events occurred during treatment. Patients experienced varying degrees of nausea, vomiting (mean: 3.7 times the first day), and abdominal pain after implantation. Six months (23–29 weeks) after End-Ball® balloon insertion, we observed a significant decrease in body weight (13.9 ±5.1 kg) and percent excess weight loss (37.9 ±12.9%). We also found a significant decrease in the levels of glycated hemoglobin (p < 0.001), C-peptide (p < 0.002), and triacylglycerols (p < 0.001) and an increase in the concentration of high-density lipoprotein cholesterol (p < 0.025). Conclusions The End-Ball® IGB is a safe and effective treatment for morbid obesity, with positive effects on weight loss and saccharide metabolism.

Health status and physical fitness of mines rescue brigadesmen.

OBJECTIVES The aim of the study was to assess health status of regular and part-time mines rescue brigadesmen. MATERIAL AND METHODS A group of 685 mines rescue brigadesmen was examined within the preventive testing - a basic internal, biochemistry and anthropometric examination, physical fitness testing. RESULTS The average age of the subjects was 41.96±7.18 years, the average exposure in mining was 20±8.1 years, out of that 11.95±7.85 years as mines rescue brigadesmen. Elevated levels of total serum cholesterol (T-CH) and low-density lipoprotein cholesterol (LDL-CH) were found in over 1/2 of the subjects. Systolic hypertension (systolic blood pressure (SBP) ≥ 140 mm Hg) was confirmed in 34%, overweight (body mass index (BMI) ≥ 25) in 62.3% and obesity (BMI ≥ 30) in 20.4% of the examined mines rescue brigadesmen. The metabolic syndrome was found in 15.2% of persons. The highest physical fitness was found in mines rescue brigadesmen and the lowest in mine officers. Limit values of maximum oxygen uptake (VO2 max/kg) determined by the management of the mine rescue station were not reached by every 3rd of all mines rescue brigadesmen. Compared with the control group of the Czech and Slovak population, the rescuers are taller, have greater BMI, higher percentage of body fat in all age categories and proportionally to that they achieve a higher maximum minute oxygen uptake; however, in relative values per kg of body weight their physical fitness is practically the same as that of the controls. CONCLUSIONS The prevalence of risk factors of cardiovascular diseases and VO2 max/kg in the group of the mines rescue brigadesmen is comparable with that in the general untrained Czech population.

A Comment on ‘Changes in Bone Mineral Density in Women Following 1-year Gastric Bypass Surgery’ Published by Casagrande DS et al.

Sirs,In a recent issue of Obesity Surgery, a study on longitudinalchanges in bone mineral density (BMD) after gastric bypasssurgery [1] was published. The authors presented severallaboratory data and BMD measurements at the spine andproximal femur at baseline and follow-up. Generally,both laboratory variables and BMD results have changedsignificantly. However, we have comments concerningmethodology of BMD measurements and the way of theirpresentation.Firstly, in a description of densitometry, the authors didnot provide a precision expressed as coefficient of variation(CV%). This information is especially important in a longi-tudinal observation. In each densitometry unit, serial mea-surements should be performed and CV% should beestablished. Moreover, in a prospective study, it is necessaryto calculate the value of the least significant change (LSC)using a common formula: RMS_CV×2×1.41. The use ofLSC allows to establish whether the BMD change in anindividual subject exceed the value of LSC.The authors presented changes in BMD only as meanexpressed in percent. Such way of presentation does notexpress real bone changes in a satisfactory manner. Onemay expect that due to precision error BMD change not ineach patient will exceed the value of LSC. In our recentstudy, we performed measurements in 29 women after lapa-roscopic sleeve gastrectomy, and after 6 months, BMD havedecreased for femoral neck, total hip and spine by 1.24, 6.99and 5.18 %, respectively [2]. We also performed an analysisof changes in individual patients using LSC, and such wayallowstoestablishthatchangeinBMDwasnotpresentinallpatients. For spine, BMD decreased only in 38 % of allwomen, andin three of them BMD even increased. In regardto femoral neck BMD, real decrease was noted in 72 %, andfor total hip BMD, a decrease exceeding the value of LSCwas observed in 82 % of all subjects studied. For hip densi-tometric measurements, an increase was not noted but insome women a decrease was not present.Our analysis confirms that we should not expect thepresence of significant bone changes in all subjects aftersurgical method of treatment of obesity. We recommend forauthorsofthecommentedstudytopresentsuchdatathatwillhelpinbetterunderstandingofbonechangesinsubjectsaftersurgical obesity management.References