1. Outcomes with Intra-gastric Balloon Therapy in BMI < 35 Non-morbid Obesity: 10-Year Follow-Up Study of an RCT
- Author
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Wilfred Lik-Man Mui, Daniel L. Chan, Josil R Cruz, Enders K.W. Ng, and Simon Kin Hung Wong
- Subjects
medicine.medical_specialty ,Nutrition and Dietetics ,Bariatrics ,business.industry ,Endocrinology, Diabetes and Metabolism ,030209 endocrinology & metabolism ,medicine.disease ,Comorbidity ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Weight loss ,law ,Internal medicine ,Diabetes mellitus ,Medicine ,030211 gastroenterology & hepatology ,Surgery ,Metabolic syndrome ,medicine.symptom ,business ,Body mass index ,Sibutramine ,medicine.drug - Abstract
Intra-gastric balloon (IGB) therapy is the most established endoscopic treatment of obesity, but there is a paucity of literature on long-term efficacy. This study aims to evaluate the short- and long-term weight loss efficacy of IGB. Double-blinded RCT with 6-month IGB vs with sham endoscopy, in body mass index (BMI) 27–35 patients. Anthropometric, fasting glucose, and lipid profile measurement as early outcomes (up to 2 years) and 10-year follow-up. Primary outcomes were total body weight loss (kg) and BMI. Secondary outcomes were new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention. Initial RCT recruited 99 patients (50 IGB vs 49 sibutramine group). Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6%). Total body weight loss at 6 (9.75 vs 7.48 kg, p = 0.03), 12 (6.52 vs 4.42 kg, p = 0.05), 18 (5.42 vs 3.57, p = 0.32), and 24 months (4.07 vs 2.93 kg, p = 0.56) favored the IGB group. Total weight loss (TWL) at 10 years (0.03 vs − 2.32 kg, p = 0.05) and %TWL (− 0.16 ± 12.8% vs − 2.84 ± 5.6%, p = 0.39) were not significantly different between groups. Follow-up BMI (30.97 ± 1.6 vs 30.38 ± 1.8 kg/m2, p = 1.00) was similar. At 10 years, new-onset diabetes mellitus, sleep apnoea, metabolic syndrome, and arthralgia were not significant (p > 0.05). Twenty-three (81%) IGB group vs 13 (56%) control expressed a willingness for further intervention (p
- Published
- 2020
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