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,
- Publikační typ
- časopisecké články MeSH
Myokines represent important regulators of muscle metabolism. Our study aimed to explore the effects of a cyclical ketogenic reduction diet (CKD) vs. a nutritionally balanced reduction diet (RD) combined with regular resistance/aerobic training in healthy young males on serum concentrations of myokines and their potential role in changes in physical fitness. Twenty-five subjects undergoing regular resistance/aerobic training were randomized to the CKD (n = 13) or RD (n = 12) groups. Anthropometric and spiroergometric parameters, muscle strength, biochemical parameters, and serum concentrations of myokines and cytokines were assessed at baseline and after 8 weeks of intervention. Both diets reduced body weight, body fat, and BMI. Muscle strength and endurance performance were improved only by RD. Increased musclin (32.9 pg/mL vs. 74.5 pg/mL, p = 0.028) and decreased osteonectin levels (562 pg/mL vs. 511 pg/mL, p = 0.023) were observed in RD but not in the CKD group. In contrast, decreased levels of FGF21 (181 pg/mL vs. 86.4 pg/mL, p = 0.003) were found in the CKD group only. Other tested myokines and cytokines were not significantly affected by the intervention. Our data suggest that changes in systemic osteonectin and musclin levels could contribute to improved muscle strength and endurance performance and partially explain the differential effects of CKD and RD on physical fitness.
- Klíčová slova
- adipokines, body composition, cytokines, endurance, ketogenic diet, myokines, strength parameters, training,
- MeSH
- chronická renální insuficience * MeSH
- cytokiny MeSH
- ketogenní dieta * MeSH
- lidé MeSH
- odporový trénink * MeSH
- osteonektin MeSH
- redukční dieta MeSH
- složení těla fyziologie MeSH
- svalová síla fyziologie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- cytokiny MeSH
- osteonektin MeSH
Obesity is a significant problem worldwide. Several serious diseases that decrease patient quality of life and increase mortality (high blood pressure, dyslipidaemia, type 2 diabetes etc.) are associated with obesity. Obesity treatment is a multidisciplinary and complex process that requires maximum patient compliance. Change of lifestyle is fundamental in the treatment of obesity. While pharmacotherapeutic options are available, their efficacy is limited. Surgical treatment though highly effective, carries the risk of complications and is thus indicated mostly in advanced stages of obesity. Endoscopic treatments of obesity are less invasive than surgical options, and are associated with fewer complications and nutritional deficits. Currently, there is a large spectrum of endoscopic methods based on the principles of gastric volume reduction, size restriction and gastric or small bowel bypass being explored with only few available in routine practice. The aim of this publication is to present an up-to-date summary of available endoscopic methods for the treatment of obesity focusing on their efficacy, safety and nutritional aspects.
- Klíčová slova
- deficience, endoscopic bariatric and metabolic treatments (EBMTs), nutrition, obesity, weight loss,
- MeSH
- bariatrická chirurgie metody MeSH
- endoskopie trávicího systému metody MeSH
- lidé MeSH
- nutriční stav * MeSH
- obezita patofyziologie chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
