Nejvíce citovaný článek - PubMed ID 26369473
BACKGROUND: Diabetes mellitus (DM) significantly impacts global health and economies. Despite various therapies, managing DM remains challenging. Bariatric surgery has shown efficacy in obese patients with type 2 diabetes mellitus (T2DM), but its utilization remains low. Innovative, less invasive endoscopic approaches such as duodenal mucosal resurfacing show potential in treating T2DM. This article presents the results of a First in Human (FIH) study using a duodenal submucosal laser ablation investigational device for T2DM treatment. METHODS: A prospective, single-arm, open-label study evaluated the safety and efficacy of the Digma System Endoscopic procedure for duodenal submucosal laser ablation in consecutive enrolled T2DM patients. RESULTS: The study was conducted from July 2017 to December 2020 and enrolled 31 patients for the Digma System Endoscopic procedure. The Dose Escalation Cohort (DEC) used sub-therapeutic laser doses for training and safety. The Treatment Cohort (TC) of 25 patients received therapeutic doses, resulting in HbA1c reductions of -0.6% at 6 months (p = 0.014) and -0.4% at 12 months (p = 0.062). Fasting glucose dropped 17.3 mg/dL (p = 0.173) at 6 months and 28 mg/dL (p = 0.022) at 12 months. Post-prandial glucose improvements were also observed. HOMA-IR improved at 3 and 6 months. PAGI-SYM and PAGI-QOL showed stable to slightly improved GI symptoms and quality of life. Two severe adverse events were unrelated to the procedure. CONCLUSION: The study demonstrates the safety, feasibility, and potential efficacy of the Digma System Endoscopic procedure. Evidence suggests improvements in HbA1c, fasting and post-prandial glucose, and HOMA-IR levels could be attributed to the Digma System Endoscopic procedure.
- Klíčová slova
- duodenal mucosal resurfacing, endoscopy, metabolism, type 2 diabetes mellitus,
- MeSH
- diabetes mellitus 2. typu * chirurgie krev MeSH
- dospělí MeSH
- duodenum * chirurgie MeSH
- glykovaný hemoglobin analýza metabolismus MeSH
- krevní glukóza analýza metabolismus MeSH
- kvalita života MeSH
- laserová terapie * metody škodlivé účinky přístrojové vybavení MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- senioři MeSH
- střevní sliznice chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- hemoglobin A1c protein, human MeSH Prohlížeč
- krevní glukóza MeSH
Obesity significantly increases the risk of developing metabolic and cardiovascular diseases. The most effective management tool for both obesity and type 2 diabetes (T2D) is bariatric/metabolic surgery. Delayed postprandial plasma triglyceride clearance contributes to the development of atherosclerosis in patients with T2D. Biliopancreatic diversion (BPD) was shown to be the most effective procedure in long-term T2D remission. However, the effect of BPD on postprandial metabolic profile has not been studied so far. In this pilot study, we therefore examined the changes in postprandial glucose, insulin, and triglyceride in women with severe obesity and T2D before surgery and then two and ten years after BPD. The studied cohort included 7 women (mean age at baseline=49.3±8.2 years) with severe obesity (mean BMI= 45.7±2.9 kg/m?) and T2D. A standardized liquid mixed-meal test was carried out in all subjects and the mean postprandial levels of plasma glucose, insulin, and triglyceride were analyzed by standard laboratory procedures. For statistical evaluation, ANOVA with Bonferroni multiple comparisons was used. Ten years after BPD not only a significant reduction of an average BMI (F=32.9, p<0.001) but also significant declines in mean postprandial plasma levels of glucose (F=155.3, p<0.001), insulin (F=69.8, p<0.001), and triglyceride (F=139.9, p<0.001) were demonstrated. The observed changes in postprandial metabolic profile may contribute to improved cardiometabolic health after bariatric surgery.
- MeSH
- bariatrická chirurgie * metody MeSH
- biliopankreatická diverze * metody MeSH
- diabetes mellitus 2. typu * chirurgie MeSH
- glukosa MeSH
- inzulin MeSH
- krevní glukóza metabolismus MeSH
- lidé MeSH
- morbidní obezita * komplikace chirurgie MeSH
- obezita chirurgie MeSH
- pilotní projekty MeSH
- triglyceridy MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- glukosa MeSH
- inzulin MeSH
- krevní glukóza MeSH
- triglyceridy MeSH
The aim of this study was to determine the effect of changes in cardiopulmonary fitness on the mental health of patients with severe obesity who underwent gastric bypass surgery (prior to and 1, 3, and 6 months after surgery). Study participants were recruited from among patients of a regional hospital in Czechia who underwent gastric bypass surgery between April 2018 and October 2019. They were eligible if they (a) were between 18 and 65 years old, (b) provided written informed consent, and (c) were able to walk independently. Twenty-six patients (age 45.4 ± 9.0 years, body mass index 45.1 ± 7.4 kg·m-2, body fat 43.8 ± 4.8%) were included in the analysis. The key finding revealed that the greater the increase in cardiopulmonary fitness (i.e., longer distance walked in the six-minute walk test, 6MWT), the better the improvement in depression score among patients who underwent bariatric surgery. In particular, increments of 10 m in the 6MWT lead to the improvement of 0.5 points on the depression subscale of the Hospital Anxiety and Depression Scale (HADS) questionnaire. As the main implication, these results suggest that patients should participate in exercise training programs to increase their fitness status for optimal physical and mental outcomes of bariatric surgery.
- Klíčová slova
- comorbidity, gastric bypass, mental health, obesity, weight loss,
- MeSH
- bariatrická chirurgie * MeSH
- cvičení MeSH
- deprese epidemiologie MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- morbidní obezita * chirurgie MeSH
- senioři MeSH
- žaludeční bypass * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
BACKGROUND: Surgery for obesity and metabolic diseases has been evolved in the light of new scientific evidence, long-term outcomes and accumulated experience. EAES has sponsored an update of previous guidelines on bariatric surgery. METHODS: A multidisciplinary group of bariatric surgeons, obesity physicians, nutritional experts, psychologists, anesthetists and a patient representative comprised the guideline development panel. Development and reporting conformed to GRADE guidelines and AGREE II standards. RESULTS: Systematic review of databases, record selection, data extraction and synthesis, evidence appraisal and evidence-to-decision frameworks were developed for 42 key questions in the domains Indication; Preoperative work-up; Perioperative management; Non-bypass, bypass and one-anastomosis procedures; Revisional surgery; Postoperative care; and Investigational procedures. A total of 36 recommendations and position statements were formed through a modified Delphi procedure. CONCLUSION: This document summarizes the latest evidence on bariatric surgery through state-of-the art guideline development, aiming to facilitate evidence-based clinical decisions.
- Klíčová slova
- AGREE II, Bariatric surgery, EAES, GRADE, Guidelines, Obesity,
- MeSH
- bariatrická chirurgie metody MeSH
- endoskopie metody MeSH
- lidé MeSH
- morbidní obezita chirurgie MeSH
- směrnice pro lékařskou praxi jako téma * MeSH
- společnosti lékařské MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH