Obesity is escalating, projected to affect 17.5% of adults globally and afflict 400 million children by 2035. Managing this intricate and chronic condition demands personalized, multidisciplinary approaches. While dietary changes, lifestyle modifications, and medications yield short-term results, long-term outcomes are often poor, with bariatric surgery standing out as the most effective option. However, only a small fraction undergoes surgery due to various barriers. Intragastric balloon (IGB) emerges as a minimally invasive alternative, approved by major regulatory bodies. This review adresses the pivotal role of IGB in obesity management, delving into its history and technological evolution.

Non-alcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease affecting approximately 25% of adults in the western world. Intragastric balloon (IGB) is an endoscopic bariatric therapy -a therapeutic endoscopic tool that has shown promise in inducing weight loss. Its role in the treatment of NAFLD is yet to be established.

To evaluate the effect of IGB as a treatment option in NAFLD.

We searched MEDLINE (PubMed) and EMBASE from inception to September 2022. We included studies evaluating the impact of IGB on obesity with the assessment of one or more liver-related outcomes and studies primarily evaluating the impact of IGB on NAFLD. We included comparative and non-comparative studies; primary outcomes were liver-related NAFLD surrogates.

We included 19 studies with 911 patients. IGB demonstrated an effect on NAFLD parameters including NAFLD activity score (NAS): mean difference (MD): -3.0 [95% CI: -2.41 to -3.59], ALT: MD: -10.40 U/L [95% CI: -7.31 to -13.49], liver volume: MD -397.9 [95% CI: -212.78 to 1008.58] and liver steatosis: MD: -37.76 dB/m [95% CI: -21.59 to -53.92]. There were significant reductions in non-liver-related outcomes of body weight, BMI, glycated haemoglobin and HOMA-IR.

Intragastric balloons may play an important role in addressing the treatment gap in NAFLD management.

Obesity is associated with different medical conditions, such as cardiologic, respiratory, gastrointestinal, and genitourinary, and constitutes a severe health problem.

This study aimed to evaluate the use of intragastric fluid-filled balloon in the reduction of weight and other measurements related to body composition.

This is a retrospective, monocentric study involving all patients who opted for the intragastric balloon Spatz® placement from January 2018 to July 2019, with fulfillment of inclusion and exclusion criteria. The patients were analyzed after 6 and 12 months after the intragastric fluid-filled balloon placed.

A total of 121 subjects were included in this study, with 83 (68.6%) females and 38 (31.4%) males. The mean age was 36 years and height was 1.64±0.09. Weight mean and standard deviation was 89.85±14.65 kg, and body mass index was 33.05±4.03; body mass index decreased to 29.4 kg/m2 with a mean weight of 79.83 kg, after 12 months of follow-up. There were statistical differences between body mass index and the 12 months in fat percentage, fat-free mass (kg), visceral fat area, and basal metabolic rate. There was a significant variation according to gender, with males having highest reduction. The percentage of excess weight loss was 46.19, and the total weight loss was 9.24 at the end of the study.

The study demonstrated a benefit of intragastric fluid-filled balloon on weight loss after 12 months. At the end of treatment, body mass index and the measurements of body composition were significantly lower. Men benefited more than women from the treatment.

It is estimated that by 2030, 38% of the world population will be overweight, and another 20% will be people with obesity. Intragastric balloons (IGBs) are an option in conjunction with lifestyle modification for the treatment of obesity. We sought to investigate the effects of IGB therapy on hemoglobin A1c (A1c), systolic and diastolic blood pressure (SBP, DBP), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (TGs).

PubMed, Embase, and Google Scholar were queried through November 2021 to identify studies that evaluated the effects of IGB therapy on selected variables at 6 months. A total of 17 studies and 1198 patients met inclusion criteria. Results were pooled using a random-effects model.

At 6-month post-IGB insertion, patients had a significant reduction in A1c (mean difference (MD): - 0.62, 95% confidence interval (CI): - 0.884 to - 0.355, p < 0.001), SBP (MD: - 8.39, 95% CI: - 11.39 to - 5.386, p < 0.001), DBP (MD: - 5.807, 95% CI: - 8.852 to - 2.76, p < 0.001), TC (MD: - 9.189, 95% CI: - 15.763 to - 2.616, p = 0.006), LDL (MD: - 5.20, 95% CI: - 9.05 to - 1.35, p = 0.008), and TGs (MD: - 25.35, 95% CI: - 40.30 to - 10.10, p = 0.001). There was no significant difference in HDL (MD: 1.245, 95% CI: - 0.11 to 2.60, p = 0.071).

Our meta-analysis suggests that IGB therapy is associated with improvements in insulin resistance, blood pressure, and dyslipidemia at 6 months. The results of this analysis suggest that IGB placement can be a viable treatment option to improve important metabolic parameters beyond weight loss alone.

Nonalcoholic fatty liver disease (NAFLD), including advanced-stage nonalcoholic steatohepatitis (NASH), is currently the most common chronic liver disease worldwide and is projected to become the leading indication for liver transplantation (LT). However, there are no effective pharmacological therapies for NAFLD. Endoscopic bariatric and metabolic therapies (EBMTs) are less invasive procedures for the treatment of obesity and its metabolic comorbidities. Several recent studies have demonstrated the beneficial effects of EBMTs on NAFLD/NASH. In this review, we summarize the major EBMTs and their mechanisms of action. We further discuss the current evidence on the efficacy and safety of EBMTs in people with NAFLD/NASH and obese cirrhotic LT candidates. The potential utility of EBMTs in reducing liver volume and perioperative complications in bariatric surgery candidates is also discussed. Moreover, we review the development of liver abscesses as a common serious adverse event in duodenal-jejunal bypass liner implantation.

Endoscopic bariatric and metabolic therapies (EBMTs) are emerging minimally invasive therapeutic options for obesity and its related complications, including non-alcoholic fatty liver disease (NAFLD). This study aimed to evaluate the effects of EBMTs on NALFD in patients with obesity.

Four databases were searched until Nov 2021. Randomized controlled trials (RCTs) and observational studies reporting liver-related outcomes following Food and Drug Administration (FDA)-approved and non-FDA-approved EBMTs were included. Liver parameters, metabolic parameters, and weight loss were evaluated. Risk of bias was assessed using the "risk of bias" tool in the Cochrane Collaboration for RCTs and the Methodological Index for Non-Randomized Studies criteria for observational studies.

Thirty-three studies with 1710 individuals were included. Regarding the effects of EBMTs on liver fibrosis, a significant decline of NAFLD Fibrosis Score, but not transient elastography-detected liver stiffness or Fibrosis-4 Index, was observed. EBMTs significantly improved liver steatosis (control attenuation parameter and Hepatic Steatosis Index), NAFLD Activity Score, and Homeostasis Model Assessment of Insulin Resistance. EBMTs reduced serum levels of alanine transaminase, aspartate aminotransferase, and gamma-glutamyl transpeptidase considerably. Moreover, EBMTs had reducing effects on the serum levels of triglycerides and total cholesterol as well as body weight.

Our meta-analysis suggested that EBMTs could ameliorate NAFLD based on the evidence of improved liver steatosis, liver function, and insulin resistance. Large-scale, prospective, long-term studies are warranted to clarify the role of EBMTs in patients with different stages of NAFLD.

Metabolic dysfunction-associated fatty liver disease corresponds to a clinical entity that affects liver function triggered by the accumulation of fat in the liver and is linked with metabolic dysregulation.

To evaluate the effects of the intragastric balloon (IGB) in patients with metabolic dysfunction-associated fatty liver disease through the assessment of liver enzymes, imaging and several metabolic markers.

A comprehensive search was done of multiple electronic databases (MEDLINE, EMBASE, LILACS, Cochrane and Google Scholar) and grey literature from their inception until February 2021. Inclusion criteria involved patients with a body mass index > 25 kg/m2 with evidence or previous diagnosis of hepatic steatosis. Outcomes analyzed before and after 6 mo of IGB removal were alanine aminotransferase (IU/L), gamma-glutamyltransferase (IU/L), glycated hemoglobin (%), triglycerides (mg/dL), systolic blood pressure (mmHg), homeostatic model assessment, abdominal circumference (cm), body mass index (kg/m2) and liver volume (cm3).

Ten retrospective cohort studies evaluating a total of 508 patients were included. After 6 mo of IGB placement, this significantly reduced alanine aminotransferase [mean difference (MD): 10.2, 95% confidence interval (CI): 8.12-12.3], gamma-glutamyltransferase (MD: 9.41, 95%CI: 6.94-11.88), glycated hemoglobin (MD: 0.17%, 95%CI: 0.03-0.31), triglycerides (MD: 38.58, 95%CI: 26.65-50.51), systolic pressure (MD: 7.27, 95%CI: 4.79-9.76), homeostatic model assessment (MD: 2.23%, 95%CI: 1.41-3.04), abdominal circumference (MD: 12.12, 95%CI: 9.82-14.41) and body mass index (MD: 5.07, 95%CI: 4.21-5.94).

IGB placement showed significant efficacy in improving alanine aminotransferase and gamma-glutamyltransferase levels in patients with metabolic dysfunction-associated fatty liver disease as well as improving metabolic markers related to disease progression.

Nonalcoholic fatty liver disease, now renamed metabolic dysfunction-associated fatty liver disease (MAFLD), is common in obese patients. Intragastric balloon (IGB), an obesity management tool with low complication risk, might be used in MAFLD treatment but there is still unexplained heterogeneity in results across studies.

We conducted a systematic search of 152 citations published up to September 2020. Meta-analyses, stratified analyses, and meta-regression were performed to evaluate the efficacy of IGB on homeostasis model assessment of insulin resistance (HOMA-IR), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (GGT), and to identify patients most appropriate for IGB therapy.

Thirteen observational studies and one randomized controlled trial met the inclusion criteria (624 participants in total). In the overall estimate, IGB therapy significantly improved the serum markers change from baseline to follow-up [HOMA-IR: 1.56, 95% confidence interval (CI)=1.16-1.95; ALT: 11.53 U/L, 95% CI=7.10-15.96; AST: 6.79 U/L, 95% CI=1.69-11.90; GGT: 10.54 U/L, 95% CI=6.32-14.75]. In the stratified analysis, there were trends among participants with advanced age having less change in HOMA-IR (1.07 vs. 1.82). The improvement of insulin resistance and liver biochemistries with swallowable IGB therapy was no worse than that with endoscopic IGB. Multivariate meta-regression analyses showed that greater HOMA-IR loss was predicted by younger age (p=0.0107). Furthermore, effectiveness on ALT and GGT was predicted by basal ALT (p=0.0004) and GGT (p=0.0026), respectively.

IGB is effective among the serum markers of MAFLD. Younger patients had a greater decrease of HOMA-IR after IGB therapy.

Intragastric balloon (IGB) therapy has shown efficacy in weight loss but its role in NAFLD remains unknown. We conducted a systematic review and meta-analysis to evaluate the efficacy of IGB in NAFLD. Meta-analysis was performed to estimate the pooled proportion of patients with improvement in steatosis as determined by imaging and histology following IGB placement. Nine studies were included in our analysis. Four hundred forty-two IGBs were placed. Improvement in steatosis was seen in 79.2% of patients and NAS in 83.5% of patients, and HOMA-IR score improved in 64.5% of patients. A reduction in liver volume by CT scan was noticed in 93.9% of patients undergoing IGB placement. IGB is an effective and safe short-term therapeutic modality for patients with NAFLD.

Obesity is an important risk factor for several chronic diseases and also is associated with worse quality of life. Intragastric balloon (IGB) is an effective method for weight loss. Although changes in lifestyle are critical to weight loss during and after IGB therapy, only a few studies evaluated dietary intake and none evaluated changes in physical activity with a validated questionnaire during the treatment. The aim of this study was to evaluate changes in total and central body adiposity, dietary intake, physical activity, and quality of life of patients with obesity submitted to IGB treatment for 6 months.

Prospective observational study involving 42 patients with obesity using IGB for 6 months. The patients were evaluated, on the day of insertion and withdrawal or adjustment of IGB for total and central body adiposity (anthropometry and bioelectrical impedance), dietary intake, physical activity (Baecke questionnaire), and quality of life (SF-36 questionnaire).

There was a significant decrease in total and central body adiposity. The mean % total weight loss and % excess weight loss were 15.88 ± 1.42 and 56.04 ± 4.90, respectively and waist circumference decreased 13.33 ± 1.39 cm. There was a reduction in energy intake, an increase in physical activity, and an improvement of quality of life during IGB treatment.

The present study suggests that IGB treatment during 6 months in individuals with obesity is effective for decreasing total and central body adiposity being associated with reduction in energy intake, increase in physical activity, and improvement in quality of life.

Intragastric balloon (IGB) insertion leads to dietary restriction; however, its neurohormonal actions were also described. Resting metabolic rate (RMR) adjusted for body mass (RMR/mass) seems to increase after bariatric interventions, whereas it generally decreases after caloric restriction-based therapies. However, no studies have evaluated the changes in body composition and RMR over IGB treatment.

To evaluate the relationships between changes in body composition, RMR, RMR/mass, and RMR adjusted for fat-free mass (FFM) (RMR/FFM) over IGB treatment lasting 6 months.

Single-center observational study.

Twenty-one morbidly obese patients treated with IGB (143 ± 20 kg, body mass index [BMI] = 49.5 ± 7.3, 98% ± 29% percent excess weight, 43.6 ± 12.6 yr) were enrolled. Changes in body composition, RMR, RMR/mass, and RMR/FFM were evaluated between 1 month before IGB insertion (time point 1 [TP1]) and 3 months thereafter (TP2). Fourteen patients were also assessed 1 month after IGB removal (TP3).

There was a 9.5% reduction in weight, a 9.4% reduction in BMI, and 19.1% decrease in percent excess weight at TP2 (n = 21; P < .001); a further 6.5% reduction in weight and BMI and a 13.1% drop in percent excess weight (n = 14, P < .001) at TP3. They were accompanied by a 5.4% reduction in FFM between TP1 and TP2 (n = 21, P < .001). Compared with pretreatment values, at TP2 RMR was 12.5% lower (P < .001) but did not change thereafter. RMR/mass increased 12.4% between TP2 and TP3 (n = 14, P = .02) but on average did not change between TP1 and TP3. The results in the smaller cohort (n = 14) between TP1 and TP2 were consistent with results obtained for the entire cohort. Similar findings were obtained for RMR/FFM. The larger increases in RMR/mass between TP1 and TP3 were associated with more weight loss, larger drop in BMI, and more loss of excess weight (r < -.55, P < .03).

This is the first study to evaluate the relationship between changes in body composition and RMR over IGB treatment. IGB therapy leads to both fat and fat-free mass reductions and RMR decreases. More weight reduction is associated with larger increases in RMR/mass.

ObjectivesTherapies less invasive than surgery and more effective than lifestyle and pharmacotherapy are needed to contend with the obesity epidemic. Intragastric balloons (IGBs) are a minimally invasive endoscopic weight loss method recently approved for use in the US. The purpose of the study is to assess the effect of IGBs on metabolic outcomes associated with obesity.MethodsMEDLINE, Embase, and Cochrane Database were searched through July 2016. Dual extraction and quality assessment of studies using Cochrane risk of bias tool were performed independently by two authors. Primary outcomes included the change from baseline in metabolic parameters. Secondary outcomes included resolution and/or improvement in metabolic co-morbidities and association with baseline parameters.Results10 randomized controlled trials (RCT) and 30 observational studies including 5,668 subjects were analyzed. There was moderate-quality evidence for improvement in most metabolic parameters in subjects assigned to IGB therapy as compared to conventional non-surgical therapy in RCTs: mean difference (MD) in fasting glucose change: -12.7 mg/dl (95% confidence interval (CI) -21.5, -4); MD in triglycerides: -19 mg/dl (95% CI -42, 3.5); MD in waist circumference: -4.1 cm (95% CI -6.9, -1.4); MD in diastolic blood pressure: -2.9 mm Hg (95% CI -4.1, -1.8). The odds ratio for diabetes resolution after IGB therapy was 1.4 (95% CI 1.3, 1.6). The rate of serious adverse events was 1.3%.ConclusionsIGBs are more effective than diet in improving obesity-related metabolic risk factors with a low rate of adverse effects, however the strength of the evidence is limited given the small number of participants and lack of long-term follow-up.

Intragastric balloons (IGBs) are safe and effective in inducing weight loss in obese patients. The objective of this study was to review and analyze the available data of the effect of IGB on markers of nonalcoholic fatty liver disease (NAFLD) and liver enzymes.

Searches were performed of MEDLINE and Embase databases from inception through January 2016. Study inclusion criteria were the following: ≥5 overweight or obese adult patients undergoing intragastric balloon placement, with liver tests [alanine aminotransferase (ALT) or gamma-glutamyl transpeptidase (GGT)] or markers of NAFLD (e.g., imaging, biopsy) reported before balloon insertion and after balloon removal at 6 months.

Nine observational studies and one randomized trial were identified. ALT decreased by -10.02 U/l (95 % CI, -13.2, -6.8), GGT decreased by -9.82 U/l (95 % CI, -12.9, -6.8), and BMI decreased by -4.98 kg/m(2) (-5.6, -4.4) with IGB therapy. Hepatic steatosis improved from baseline after 6 months of balloon therapy by magnetic resonance imaging (fat fraction, 16.7 ± 10.9-7.6 ± 9.8, p = 0.003), ultrasound (severe liver steatosis, 52-4 %, p < 0.0001). Histological NAFLD activity score was lower after 6 months of IGB versus control with sham endoscopy and diet (2 ± 0.75 vs. 4 ± 2.25, p = 0.03).

The use of intragastric balloon decreases liver enzymes and is potentially an effective short-term treatment for NAFLD as part of a multidisciplinary approach. Larger, more rigorous trials are needed to confirm the effect of IGBs on NAFLD.

The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%–16.73%), 13.16% (95% CI, 12.37%–13.95%), and 11.27% (95% CI, 8.17%–14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.

Morbid obesity is strongly associated with nonalcoholic fatty liver disease (NAFLD), which is one of the most common causes of chronic liver disease worldwide. The present best treatment for NAFLD and nonalcoholic steatohepatitis (NASH) is weight reduction through lifestyle modification. Because of frustrating inefficiency of such a therapeutic approach, bariatric surgery is increasingly performed in adolescents as an alternative option for weight reduction. Standards of care and consensus for indications are, however, scarce. We explore the indications and limitations of bariatric surgery in children with severe obesity with and without NASH and aim to provide guidance for the exceptional indications for adolescents with extreme obesity with major comorbidity that may benefit from these controversial interventions. Present evidence suggests that bariatric surgery can decrease the grade of steatosis, hepatic inflammation, and fibrosis in NASH. Uncomplicated NAFLD is not an indication for bariatric surgery. Roux-en-Y gastric bypass is considered a safe and effective option for adolescents with extreme obesity, as long as an appropriate long-term follow-up is provided. Laparoscopic adjustable gastric banding has not been approved by the Food and Drug Administration for use in adolescents and therefore should be considered investigational. Finally, sleeve gastrectomy and other types of weight loss surgery that have grown increasingly common in adults, still need to be considered investigational. Temporary devices may be increasingly being used in pediatrics; however, future studies, including a long-term risk analysis of patients who undergo surgery, are much needed to clarify the exact indications for bariatric surgery in adolescents.

There are limited controlled data for intragastric balloons (IGB) in obesity treatment. This randomized, controlled study evaluated the efficacy and safety of an IGB in obese individuals with metabolic syndrome (MS).

Sixty-six adults (BMI: 30-40 kg/m(2)) were randomized to IGB for 6 months, with a 12 month behavioral modification (IGB Group; "IGBG"), or 12 month behavioral modification alone (Control Group; "CG"). The primary outcome was percentage change in body weight.

Thirty-one subjects (female: 68%; mean age: 43; mean BMI: 36.0) were randomized to IGBG and 35 (66%; 48; 36.7) to CG. At 6 months, there was a significantly greater weight loss in the IGBG: -14.2 vs. -4.8; P < 0.0001. This was associated with a significantly greater reduction in waist circumference, and an improvement in quality of life, with a trend for a larger %MS remission (50% vs. 30%; n.s.). At month 12, the differences in weight loss were enduring: -9.2 vs. -5.2; P = 0.007. Gastrointestinal-related adverse events were common in the IGBG, resolving predominantly within two weeks. The IGB was removed prematurely in three subjects (one for refractory gastrointestinal symptoms).

Statistically significant and clinically relevant improvements in weight loss and health outcomes were observed with the IGBG at 6 months versus behavioral modification alone. The differential weight loss was still evident 6 months after IGB removal.

Abstract Background: The surgical management of morbid obesity is faced by several challenges. Alternative therapeutic strategies could have an important role in the perioperative risk reduction. The BioEnterics(®) intragastric balloon (BIB) (Inamed Health, Santa Barbara, CA) has been described as being effective in weight reduction and is used as a bridge before bariatric surgery. This study examined the efficacy of BIB in obese Egyptian patients and the value of the extended low caloric liquid diet program in weight loss.

A retrospective review of a prospectively maintained bariatric database was conducted. Weight changes and complications data were analyzed. Indications for BIB placement were discussed.

Records of 55 patients (11 males and 44 females) were retrieved. The mean initial body mass index (BMI) was 45.3±11 kg/m(2). The mean of excess body weight percentage was 111.96±53.2%. Nausea was reported in 30 patients (54.5%). Epigastric discomfort was reported in 23 patients (41.8 %), and vomiting was reported in 27 patients (49.1%). Six patients (10.9%) had an early removal of the balloon, whereas 4 (7.2%) had delayed removal (more than 6 months). The mean excess weight loss percentage (EWL%) was 17.2%. There was significant reduction in patients' BMI from 45.3 to 38.3 kg/m(2) (P<.001). There was no significant correlation between the EWL% and the gender, age, or initial BMI. Two patients had second balloon insertions without complications. There was no significant difference in the EWL% between the 1-week liquid diet group and the extended (4-week) low caloric diet group.

The BIB is effective and safe in weight reduction in obese Egyptian patients. The impact of extended liquid dieting period is not significant.