RESUMEN
BACKGROUND: The BioEnterics Intragastric Balloon (BIB) has been proposed as an adjuvant therapy for the short-term treatment of obesity. The temporal pattern of BIB-induced satiety and whether this effect is mediated by modification of ghrelin levels is unknown. METHODS: Patients with treatment-resistant morbid obesity were invited to participate in a randomized, double-blind, sham-controlled trial of 4-month duration. Anthropometric and biochemical parameters, estimation of energy intake, and pre- and postprandial evaluation of satiety were required monthly. Ghrelin response after a standard mixed meal was scheduled prior to and 4 weeks after the endoscopic procedure. RESULTS: 21 out of 22 enrolled patients completed the study (17 women, 5 men; 35.9 +/- 9.9 years; BMI 50.4 +/- 7.8 kg/m2). Pre-intervention weight decreased from 143.8 +/- 31.2 kg to 131.1 +/- 32.6 kg in Group Balloon (P < 0.001) and from 138.8 +/- 24.5 kg to 129.9 +/- 25.6 kg in Group Sham (P < 0.01) at the end of the study. Weight loss was not significantly different in Group Balloon and Group Sham at any time-point of the follow-up. Only patients from Group Balloon showed a temporary increased pre- and postprandial satiety, which was maximal at 4 weeks after the intervention. Total area under the curve, fasting and postprandial plasma ghrelin were not significantly different between groups at inclusion or 4 weeks after follow-up. No correlation was found between any of the satiety scores at any time-point with their comparable ghrelin levels. CONCLUSION: BIB induces a temporary sense of satiety in morbidly obese patients which is not mediated by modification of fasting or postprandial levels of plasma ghrelin.