Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity
| Autor: | J M Swain, Annick M. E. Alleleyn, Nicole D. Bouvy, David Williams, Givan F. Paulus, M. van Avesaat, Adrian A. M. Masclee, T L Abell, S. van Rijn |
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| Přispěvatelé: | Surgery, MUMC+: MA Med Staf Artsass Interne Geneeskunde (9), RS: NUTRIM - R2 - Liver and digestive health, Interne Geneeskunde, MUMC+: MA AIOS Heelkunde (9), RS: NUTRIM - R1 - Obesity, diabetes and cardiovascular health, MUMC+: MA Heelkunde (9), MUMC+: MA Maag Darm Lever (9) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
Quality of life medicine.medical_specialty Weight loss FOOD-INTAKE Original Contributions Endocrinology Diabetes and Metabolism medicine.medical_treatment Gastric motility Electric Stimulation Therapy 030209 endocrinology & metabolism Stimulation Gastric emptying Gastroenterology Morbid obesity 03 medical and health sciences 0302 clinical medicine Food intake Internal medicine medicine Humans Prospective Studies Lead (electronics) Prospective cohort study Meal Nutrition and Dietetics business.industry Insulin Gastric electrical stimulation Electric Stimulation Electrodes Implanted Obesity Morbid Female 030211 gastroenterology & hepatology Surgery WEIGHT medicine.symptom business TRIGLYCERIDES PREDICT |
| Zdroj: | Obesity Surgery, 30(5), 1952-1960. Springer, Cham Obesity Surgery |
| ISSN: | 0960-8923 |
| Popis: | Background and Aims To assess safety of the Exilis™ gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Gastric emptying and motility and meal intake were evaluated. Method In a multicenter, phase 1, open prospective cohort study, 20 morbidly obese subjects (17 female, mean BMI of 40.8 ± 0.7 kg/m2) were implanted with the Exilis™ system. Amplitude of the Exilis™ system was individually set during titration visits. Subjects underwent two blinded baseline test days (GES ON vs. OFF), after which long-term, monthly follow-up continued for up to 52 weeks. Results The procedure was safe, and electrical stimulation was well tolerated and comfortable in all subjects. No significant differences in gastric emptying halftime (203 ± 16 vs. 212 ± 14 min, p > 0.05), food intake (713 ± 68 vs. 799 ± 69 kcal, p > 0.05), insulin AUC (2448 ± 347 vs. 2186 ± 204, p > 0.05), and glucose AUC (41 ± 2 vs.41 ± 2, p > 0.05) were found between GES ON and OFF. At week 4, 13, and 26, a significant (p Conclusion Gastric electrical stimulation with the Exilis™ system can be considered as safe. No significant effect on food intake, gastric emptying, or gastric motility was observed. The reduction in weight loss with Exilis™ GES was significant but short lasting. Further electrophysiological research is needed to gain more insight in optimal stimulation parameters and lead localization. |
| Databáze: | OpenAIRE |
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