OBES SURG (2009) 19:1084–1088DOI 10.1007/s11695-009-9879-6 Improvement of Metabolic Syndrome Following IntragastricBalloon: 1 Year Follow-up Analysis Nicola Crea & Giacomo Pata & Domenico Della Casa &Luigi Minelli & Giovanni Maifredi & Ernesto Di Betta &Francesco Mittempergher Received: 9 March 2009 / Accepted: 7 May 2009 / Published online: 9 June 2009 # Springer Science + Business Media, LLC 2009 16.7%, and 30.4% at t0 and 21.3%, 17.4%, 18.9%, and Objective This study aimed to assess the impact of intra- 34.8% at t12. HbA1c blood concentration shifted from an gastric balloon (IGB)-induced body weight loss on meta- initial value of 7.5±2.1% to 5.7±1.9% (t0), 5.6±0.7% (t6), bolic syndrome in obese patients and evaluate what and 5.5±0.9% (t12). Patients suffering from DM or BH stopped or diminished relative drug consumption at t12.
Methods To this end, data were collected on 143 obese Negligible modifications were reported as regards HDL patients (body mass index (BMI) 36.2±5.7 kg/m²) who underwent IGB insertion between January 2000 and Conclusion Weight regain is commonly observed during December 2005. Outcomes were recorded at BioEnterics long-term follow-up after IGB removal. Nevertheless, the Intragastric Balloon removal time (t0) and at 6-month (t6) maintenance of at least 10% of the BWL%, as reported at 1-year follow-up, is associated with an improvement in Results Significant BMI, excess body weight loss percent- age, and body weight loss percentage (BWL%) wereobserved at t0 (29.6±4.6 kg/m²; 29.3±4.8%; 14.1±5.7%), Keywords Intragastric balloon . Obesity . Metabolic followed by partial weight regain at t12 (32.4±4.3 kg/m²; 26.1±4.9%; 11.2±4.6%). Incidence of metabolic syndromedropped from 34.8% (pre-IGB value) to 14.5% (t0) and11.6% (t12). Likewise, type 2 diabetes mellitus (DM), hypertriglyceridemia, hypercholesterolemia, and blood hy-pertension (BH) incidence decreased from 32.6%, 37.7%, Although intensive research has demonstrated that the 33.4%, and 44.9% (pre-IGB values) to 20.9%, 14.5%, weight gain is often associated with a cluster of metabolicalterations such as diabetes mellitus, blood hypertension, N. Crea (*) : G. Pata : E. Di Betta : F. Mittempergher dyslipidemia, heart and brain vascular diseases, degenera- Department of Medical and Surgical Sciences, General Surgery, tive diseases of the joints, hepatic steatosis (with or without cirrhosis), and sleep apnea –], no study has been reported so far assessing the impact of intragastric balloon 25123 Brescia, Italye-mail: (IGB)-induced body weight loss on obesity-related meta-bolic syndrome in long-term follow-up.
Currently, intragastric balloons (air- or liquid-filled) are Department of Medical and Surgical Sciences, applied in patients with body mass index (BMI)>30 kg/m² Surgical Endoscopy, University of Brescia, associated with obesity-related illnesses who failed torespond to conservative management and in subjects whose cardiocirculatory or respiratory conditions preclude any Department of Experimental and Applied Medicine, Institute of Hygiene, Epidemiology and Public Health, University of Brescia, exploiting the improvement of comorbidities expected after balloon removal and to minimize surgical and anesthetic hypertensive patients as high as 161 ± 13.7 and 94 ± risks [, Tolerance and efficacy in terms of body weight 12.3 mmHg, respectively. Type 2 DM was found in loss have been the most frequently assessed aspects of this 32.6% of patients, with values of HBA1C as high as 7.5± 2.1% among the 45 DM cases. Hyperuricemia (values ≥ The aim of this study was to evaluate whether the 7 mg/dL) was reported in 26.1% of patients. Hyper- intragastric-balloon-induced body weight loss might have triglyceridemia, hypercholesterolemia, and low HDL cho- an impact on the metabolic syndrome and its protagonists, lesterol levels were present in 37.7%, 33.4%, and 31.9% of such as diabetes mellitus, blood hypertension, and dyslipi- the patients, respectively (Table No case of micro- demia and to discover what the trend of these modifications Our indications for the BIB placement were: BMI> 30 kg/m² without the criteria for a surgical treatment,superobese patients for reducing perioperative risk, and selection of patients for a gastric restrictive surgery.
The absolute contraindications taken into consideration for Between January 1, 2000 and December 31, 2005, 143 patient selection were voluminous hiatus hernia (>5 cm), consecutive obese patients were admitted to our Depart- abnormalities of the pharynx and esophagus, esophagus ment of General Surgery for bariatric treatment by means of varicose veins, use of anti-inflammatory or anticoagulant IGB insertion (Bioenteric Intragastric Balloon (BIB)® drugs, pregnancy and psychiatric disorders. We considered as Inamed Health, Santa Barbara, CA, USA). We treated 41 relative contraindications esophagitis, ulceration, and acute males (28.7%) and 102 females (71.3%). The mean age was lesions of the gastric mucous membrane. The BIB was placed 36.2±9.7 years; the mean weight at admission was 98.5± under sedation with endoscopic control and removed after an 16.3 kg and the mean BMI 36.2±5.7 kg/m². The mean average period of 6 months with the same procedure. It was excess weight was 39.1 ± 5.1 kg (Table Particular filled with 500 ml of saline and the addition of 0.1% of attention was paid to patients’ obesity-related comorbidities methylene blue as a means of alerting patients should (i.e., blood hypertension, type 2 diabetes mellitus, dyslipi- unexpected premature rupture of the balloon occur. Patients demia, and hyperuricemia), which were recorded at the first followed a fluid diet from the second day after procedure, with a regular diet (1,200-kcal/day diet) gradually introduced after Before balloon insertion (IGB0), 34.8% of patients 1 week. Proton pump inhibitor (esomeprazole 40 mg daily) showed the cluster of metabolic alterations known as was given for the entire treatment period to prevent gastric metabolic syndrome. The diagnosis of metabolic syndrome was made according to WHO criteria [(BMI≥30 kg/ All patients were closely followed for 12 months after m², waist to hip circumference ratio >0.90 in men and balloon removal with a standardized follow-up protocol.
>0.85 in women, fasting blood glucose≥110 mg/dL, overt The blood glucose and HbA1c values, triglycerides, total diabetes mellitus (DM), triglycerides≥150 mg/dL, high- cholesterol, HDL cholesterol, uric acid, and the blood density lipoprotein (HDL)-cholesterol <40 mg/dL in men pressure were evaluated for each patient at BIB removal and <50 mg/dL in women, arterial blood pressure≥140/ time (t0) and then after 6 months (t6) and 12 months (t12) 90 mmHg, and presence of microalbuminuria). Patients during routine follow-up investigations. The body weight should have at least three of these criteria to be diagnosed loss percentage (BWL%), BMI reduction, and excess of body weight loss percentage (EWL%) were recorded.
The incidence of hypertension was 44.9%, with the Statistical analysis was performed with software for values of systolic and diastolic blood pressure in 62 biomedical research (McCalc® Software for Window;version The paired-samples t test was used toanalyze differences in continuous data (presented as mean ± Table 1 Body weight changes in terms of BMI (body mass index), standard deviation) between two groups of patients (before EWL% (excess weight loss percentage), and BWL% (body weight and after treatment), while the chi-squared test was used for loss percentage) at balloon removal time (T0) and during follow-up (t6:6 months; was considered as statistically significant.
In two (1.4%) patients, BIB removal was performed just a Values are expressed as mean±standard deviation.
few days after its insertion due to persistent vomiting Table 2 Metabolic modifications following intragastric balloon treatment: outcomes at removal time (t0), 6-month follow-up (t6), and 1-yearfollow-up (t12) IGB0 before intragastric balloon positioning, DM diabetes mellitus despite antiemetic drugs. We observed two cases of balloon (difference = 18 mmHg; 95% CI = 13–23; p<0.001 for migration and one case of rupture, which required prema- systolic; difference =19 mmHg; 95% CI=14.7–23.3; p< ture balloon extraction. In the 138 remaining patients, the 1- 0.001 for diastolic blood pressure, respectively). Likewise year follow-up after balloon removal was completed and with results reported by DM patients, all subjects who they were therefore eligible for the study. A significant BMI failed to reach a normalization of blood pressure values at t0 reduction was achieved at BIB removal time 29.6±4.6 kg/ (42 cases) did improve their pressure condition, thereby m² (difference=6.6; 95% confidence interval (CI)=5.37– reducing their need for antihypertensive drugs. The meta- 7.83; p<0.001). Likewise, we observed a BWL% as high as bolic modifications which we recorded at t6 and t12 were 14.1±5.7%, with an EWL% as high as 29.3±4.8% (p< similar to the results observed at t0, while they significantly 0.001). Compared with values recorded at t0, patients’ BMI improved when compared with those observed at IGB0 showed a significant gain 6 and 12 months after balloon (Figs. and ). Blood hypertension, hypertriglyceridemia, extraction 31.1±3.7 and 32.4±4.3 kg/m2, respectively (p= and hypercholesterolemia were present, respectively, in 0.0031 and <0.001), although this remained significantly 32.6%, 15.2%, and 16.7% of cases at t6 (p=0.79; 0.99 lower than the BMI recorded at IGB0 (p<0.0001). The and 1, respectively), which did not differ much from values EWL% measured at the same time intervals displayed a observed at t12 (34.8%, 17.4%, and 18.9%, respectively; p= similar trend: 27.4±4.7% and 26.1±4.9%, respectively (p= 0.79, 0.74, and 0.75, respectively). Patients who were 0.001 and <0.001 when compared with values at T0; classified as hypertensive at IGB0 reported systolic and Fig. ). At IGB removal time (after a mean treatment diastolic blood pressure values as high as 138 ± 15.3 and period of 178±21 days), metabolic syndrome incidence had 73 ± 12.6 mmHg, respectively, at t6 and 142±13.1 and 72± dropped to 14.5% (difference=20.3%; 95% CI=10.42– 11.4 mmHg, respectively, at t12 (difference=4 mmHg; 30.18; p<0.001); the incidence of DM had been reduced to20.9% (difference=11.7%; 95% CI=1.35–22.05; p=0.039),while there was a decrease in insulin or metforminrequirement in the remaining diabetic patients (Table ).
Among DM patients, the mean HbA1c improved signifi-cantly compared with baseline values (5.7±1.9%; differ-ence=1.8%; 95% CI 0.96–2.64; p=0.0001; Fig. ). As fortotal cholesterol and triglyceride levels, only 16.7% and14.5% of patients continued suffering from such metabolicalterations at t0 (p=0.0022 and <0.0001, respectively). Nosignificant change was observed in HDL levels afterballoon removal nor in uric acid blood concentration. Theincidence of blood hypertension dropped to 30.4% aftertreatment (difference =14.5%; 95% CI=3.2–25.8; p=0.018;Fig. The systolic and diastolic blood pressure of Fig. 1 Body weight changes in terms of body mass index (BMI, kg/m²), excess weight loss percentage (EWL%), and body weight loss hypertensive patients decreased to 143±14.4 and 75± percentage (BWL%) at balloon removal time (T0) and during follow- 11.7 mmHg, respectively, after 6 months of IGB treatment Fig. 2 Metabolic modificationsfollowing intragastric-balloon-induced body weight loss:outcomes are expressed asincidence (%) at balloonremoval time (T0), 6-monthfollow-up (T6), 1-year follow-up(T12). IGB0=before intragastricballoon positioning;DM=diabetes mellitus;Hypert=blood hypertension;Hypercol=hypercholesterol-emia; Hypertr=hypertriglyceri-demia; Met Syndr=metabolicsyndrome 95% CI = −1.06–9.06; p=0.12 for systolic; difference= 1 mmHg; 95% CI = −3.05–5.05; p=0.626 for diastolicblood pressure). The incidence of DM was 22.5% at t6 and Obese patients show a higher risk of mortality []. In 21.3% at t12 (p=0.86 and 0.92, respectively, as compared the long term, more than 95% of obese patients who are with t0). Also, blood concentration of HbA1c in patients submitted to conventional treatments (diet therapy, in- presenting DM at IGB0 displayed further reduction, creased physical activity, behavior change, and drug although not statistically significant 5.6 ± 0.7% at t6 (p= therapy) undergo the “rubber effect,” which means that 0.67) and 5.5 ± 0.9% at t12 (p=0.422). No significant they cannot maintain the optimal weight and drop back to change was observed in HDL levels at T6 and T12, nor in the previous weight –Treatment for obesity should uricemia. We observed an average BWL% as high as 11.2 ± aim for the improvement and well-being of patients as well 4.6% at the end of follow-up. At t6 and t12, the overall as the metabolic health of the individual, decreasing the risk incidence of the metabolic syndrome continued to be of future diseases. With the failure of conservative treat- inferior to values measured prior to the treatment, showing ments in producing permanent weight loss, other further improvement (although scarcely significant) when approaches have to be considered, such as bariatric surgery.
compared with data recorded at balloon removal time The intragastric balloon is the mildest nonmedical treatment (13% and 11.6%, respectively; p=0.85 and 0.59).
of obese patients and it should be usefully included in thetherapeutic strategies of the obesity surgeon.
Several studies have evaluated the efficacy of the IGB placement in terms of weight loss at 6 months or, atmost, 12 months of follow-up. Most of them concludedthat this procedure cannot be considered as the onlytreatment for the disease because the results obtainedneed to be consolidated by a definitive surgical procedure, Herve and Mathus-Vliegen [evaluated the weight regain 1 year after IGB removal and reported that theirpatients regained 41% and 28%, respectively, of the weightloss. Furthermore, Herve reported that only 56% of patientshad ≥20% excess weight loss after 1 year, as compared with74% at removal time; Mathus-Vliegen detailed that thepercentage of patients with a weight loss ≥10% decreasedfrom 75% at the BIB removal to 47% after 1 year.
Fig. 3 Trend of HbA1c blood concentration (mean ±95% confidence Beside the weight loss, only a few studies have been interval CI) following intragastric balloon-induced body weight loss: performed so far to assess the effect of the BIB positioning outcomes are evaluated at balloon removal time (T0), 6-month follow- on obesity related comorbidities. A large retrospective up (T6), 1-year follow-up (T12). IGB0=before intragastric balloonpositioning study by the Italian group for Lap-Band has shown that the weight loss induced by the BIB, though modest, caused 3. Doldi SB, Micheletto G, Perrini MN, et al. Treatment of morbid obesity with intragastric balloon in association with diet. Obes most comorbidities associated with obesity to be either resolved or improved, in particular respiratory disorders, 4. De Waele B, Reynaert H, Urbain D, et al. Intragastric balloons for hypertension, type 2 diabetes, and osteoarthropathy ].
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They reported a resolution of comorbidities in 44.3% of 5. Wahlen CH, Bastens B, Herve J, et al. The BioEnterics Intra- gastric Balloon (BIB): how to use it. Obes Surg. 2001;11:524–7.
subjects at the end of the treatment and an improvement of 6. Spyropoulos C, Katsakoulis E, Mead N, et al. Intragastric balloon comorbidities with reduced pharmacological dosage in for high-risk super-obese patients: a prospective analysis of 44.8% of cases, while no change was observed in 10.9% efficacy. Surg Obes Relat Dis. 2007;3:78–83.
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8. Imaz I, Martinez-Cervell C, Garcia-Alvarez EE, et al. Safety and No study is actually available assessing the long-term effectiveness of the intragastric balloon for obesity. A meta- evolutions (at 1 year or more) of metabolic syndrome analysis. Obes Surg. 2008;18:841–6.
following intragastric-balloon-induced body weight loss.
9. Mittempergher F, Di Betta E, Pata G, et al. The obstructive sleep apnea in bariatric surgery. Ann Ital Chir. 2008;79:165–70.
This lack prompted us to estimate what happens to our 10. Alberti KG, Zimmet PZ. Definition, diagnosis and classification obese patients in a long-term follow-up protocol. We of diabetes mellitus and its complications. Part 1: diagnosis and observed an average body weight loss as high as 14.1± classification of diabetes mellitus provisional report of a WHO 5.7% at BIB removal time and a partial weight regain at consultation. Diabet Med. 1998;15:539–53.
11. Strazzullo P, Barbato A, Siani A, et al. Diagnostic criteria for 1-year follow-up (average weight loss > 10%). Such metabolic syndrome: a comparative analysis in an unselected maintenance of the body weight loss, although partial, sample of adult male population. Metabolism. 2008;57:355–61.
proved sufficient in preserving the benefits obtained for 12. Pischon T, Boeing H, Hoffmann K, et al. General and abdominal obesity-related comorbidities at the end of the treatment adiposity and risk of death in Europe. N Engl J Med.
(t0). HDL cholesterol and uric acid blood concentration 13. Ammar KA, Redfield MM, Mahoney DW, et al. Central obesity: have been the only parameters which remain largely association with left ventricular dysfunction and mortality in the unchanged in our patients, while the incidence of metabolic community. Am Heart J. 2008;156:975–81.
syndrome, blood hypertension, hypertriglyceridemia, type 2 14. Shimabukuro M. Cardiac adiposity and global cardiometabolic risk: new concept and clinical intervention. Circ J. 2008;73:27–34.
DM, and hypercholesterolemia have been clearly demon- 15. Artham SM, Lavie CJ, Patel HM. Impact of obesity on the risk of strated as diminishing at both 6 months and 1 year heart failure and its prognosis. J Cardiometab Syndr. 2008;3:155–61.
16. Franz MJ, VanWormer JJ, Crain AL, et al. Weight-loss outcomes: The crucial role of such a cutoff (10%) of body weight a systematic review and meta-analysis of weight-loss clinical trialswith a minimum 1-year follow-up. J Am Diet Assoc.
loss percentage has been previously highlighted by Deitel and colleagues ]. Likewise, Imaz et al. reported that 17. Avenell A, Brown TJ, McGee MA, et al. What interventions the loss of 10% of the weight is sufficient to improve should we add to weight reducing diets in adults with obesity? A certain morbid conditions associated with obesity (blood systematic review of randomized controlled trials of adding drugtherapy, exercise, behaviour therapy or combinations of these hypertension, diabetes, hyperlipidemia) and also to reduce interventions. J Hum Nutr Diet. 2004;17:293–316.
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balloon is an effective device for obtaining a body weight 19. Herve J, Wahlen H, Schaeken A, et al. What becomes of patients one year after the intragastric balloon has been removed? Obes loss, but long-term results are poor since weight regain is usually expected. Nevertheless, the maintenance of at least 20. Angrisani L, Lorenzo M, Borrelli V, et al. Is bariatric surgery 10% of body weight loss, as reported at 1-year follow-up, necessary after intragastric balloon treatment? Obes Surg.
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22. Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastric Balloon: the Italian Experience with 2.515 patients. Obes Surg.
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