Systematic Literature Review on the Impact of Weight Loss from Adjustable Gastric Banding on Diabetes, Hypertension, and Dyslipidemia

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1 Systematic Literature Review on the Impact of Weight Loss from Adjustable Gastric Banding on Diabetes, Hypertension, and Dyslipidemia I. Introduction Laparoscopic adjustable gastric banding (LAGB) surgery involves the use of a silicone device that contains an inflatable gastric band connected to a reservoir port. The gastric band is implanted to encircle the top portion of the upper stomach creating a smaller stomach pouch just below the esophagogastric junction. The reservoir port is placed subcutaneously and is injected with saline solution to adjust the pouch outlet for effectiveness and comfort. Gastric banding is intended to restrict the size of the stomach to promote early satiety and appetite control leading to weight loss. FDA conducted a systematic literature review to assess the effect of LAGB devices on weight loss and obesity-associated comorbidities by analyzing the clinical literature. More specifically, we sought to address the following questions: What is the evidence for the effect of weight loss from LAGB on (1) type 2 diabetes mellitus (T2DM), (2) hypertension, and (3) dyslipidemia? What are the reported adverse events associated with the use of LAGB devices for weight loss in these studies? II. Methods On March 2, 2012, FDA conducted a systematic search of the literature using PubMed, EMBASE, and CINAHL electronic databases. The search was constructed to find clinical studies with elements of each of the following three domains: 1) Use of LAGB device 2) Weight loss 3) At least one of the following three conditions: diabetes, hypertension, or dyslipidemia The following string of terms was used to characterize each domain. The three searches were combined so that an article was retrieved from the database if it included at least one term from each domain: 1. LAGB device (("REALIZE adjustable gastric band") OR ("Lap-band adjustable gastric band") OR ("lap band") OR (band*)) AND (("gastric") OR ("adjustable") OR ("laparoscopic") OR ("intragastric") OR ("Model 2200")) 1

2 2. Weight loss ("weight") OR ("weight loss") OR ("obese") OR ("obesity") OR ("BMI") OR ("body mass index") (("hyperlipidemia") OR ("cholesterol") OR ("LDL") OR ("HDL") OR ("hypercholesterolemia")) OR 3. Condition of interest (("diabetes") OR ("fasting glucose") OR ("HBA1C") OR ("oral glucose tolerance") OR ("glucose test")) OR (("hypertension") OR ("BP") OR ("Blood pressure") OR ("diastolic") OR ("systolic")) Combined search #1 AND #2 AND #3. Limits: Humans, English language, Published from January 1, 2001 Present Since the first lapband device was approved on June 5, 2001 in the United States, results were limited to human studies published in English from the beginning of that year to the present. Randomized controlled trials, observational studies, systematic literature reviews and metaanalyses were considered for inclusion. The initial search of all three databases yielded 776 results, which was reduced to 549 when duplicate articles were removed (Figure 1). Titles and abstracts were reviewed for clinical studies involving components from each of the three domains. As a result, 350 articles were excluded for the following reasons: (1) non-clinical studies (i.e., editorials, commentaries, discussions, cost-analyses, or overviews) (n=111); (2) case reports (n=54); (3) non-human studies (i.e., animal and tissue sample studies) (n=6); (4) studies not involving LAGB devices (e.g., Roux-en-Y gastric pass, biliopancreatic diversion, abdominoplasty, intragastric balloon) (n=91); (5) studies without a relevant research question or outcomes (e.g., studies on anesthesia during bariatric surgery, impact of genetic polymorphisms on weight loss, behavioral interventions such as dieting, surgical technique of band placement) (n=60); (6) studies not investigating all three components (n=22); and (6) studies which contained all three components but did not evaluate the impact of weight loss on the specific conditions of interest (n=6). After the initial review of abstracts based on the above criteria were made, the full texts of 199 articles were assessed by two reviewers for relevance. At this stage, an additional 182 articles 2

3 were excluded for the following reasons: (1) case series with sample size 20 (n=35); (2) nonsystematic literature review (n=8); (3) conference proceeding (n=1); (4) did not evaluate impact of weight loss on conditions of interest (n=99); (5) no weight loss or condition of interest data (n=10); (6) analysis not stratified by bariatric procedure type (n=7); and (7) research question or outcomes not relevant (n=22). Seventeen articles were included as part of the final qualitative synthesis. A summary of article retrieval and selection is provided in Figure 1. Test statistics and corresponding p-values are reported when available in the literature. Relationships with P<0.05 were considered statistically significant. III. Results The results of our systematic literature review are presented separately for the effect of LAGBinduced weight loss on: 1) diabetes, 2) hypertension, and 3) dyslipidemia. The review identified studies that utilized correlation estimates or statistical modeling to evaluate the impact of weight change from LAGB on either clinical classification and/or biomarkers related to one or more of the comorbidities. We provide a brief description of the studies, main findings regarding the impact of LAGB-induced weight loss on each comorbidity, reported complications and adverse events in these studies, and discussion of the critical findings. A. Overview of Published Literature Seventeen articles were included in our systematic literature review, including 1 randomized clinical trial (RCT) 1 and 16 observational studies The studies were conducted in the United States 2, 4, 5, Australia 1, 7-10, Italy 3, 11, 13-16, Germany 6, Switzerland 12, and the United Kingdom 17. Sample size ranged from 26 to 650 patients, with 47% of studies (8/17) enrolling less than 100 patients. 1, 4-6, 8, 10, 12, 15 The average follow-up period ranged from 6 months to 5 years, with , 5-9, 11-15, 17 studies reporting at least 1 year of follow-up. Prior to LAGB placement, the mean body mass index (BMI) ranged from 37.0 to 52.5 kg/m 2. The studies utilized at least one of the following measures to assess post-lagb weight loss: absolute weight loss (WL) in kilograms, total body loss (%TBL), percent excess weight loss (%EWL), and changes in BMI, waist circumference (WC), hip circumference (HC), total fat mass, visceral fat, and subcutaneous fat. B. Effectiveness 1. Type 2 Diabetes Mellitus Sixteen studies evaluated the impact of LAGB-induced weight loss on diabetes. The majority of studies evaluated diabetes-related biomarkers, including: fasting glucose, fasting insulin, hemoglobin A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), homeostatic model assessment of insulin sensitivity (HOMA %S), and beta cell activity (HOMA %β). In two studies that included only patients with diabetes 1, 10, the primary endpoints were diabetes remission and discontinuation of diabetes medications. 3

4 The literature review included one RCT that randomized patients with diabetes to either LAGB or conventional medical therapy for weight loss. 1 In this study, higher WL% was associated with T2DM remission, independent of baseline HbA1c, at 2 years follow-up (Cox-Snell r 2 =0.50, P<0.001). Moreover, weight loss alone explained most of the variance in diabetes remission (Cox-Snell r 2 =0.46, P<0.001). The relationship between weight loss and change in diabetes status or severity was also reported in two observational studies. In a study by Dolan et al., %EWL was a predictor of T2DM remission (nr, P=0.01). 10 However, Segato et al. did not find a correlation between %EWL and either reduction or suspension of diabetes medications at 3 years of follow-up (β coefficient= , P=0.076). 15 Two studies that examined the relationship between weight loss and changes in HbA1c levels reported inconsistent findings. One study found a greater reduction in HbA1c levels in patients with the largest decrease in BMI (highest quartile of BMI change) as compared to those with the smallest decrease in BMI (lowest quartile of BMI change) (nr a, P<0.05) 14. Yet, another study reported no correlation between %EWL and a decrease in HbA1c (r= -0.28, P=0.149) 17. Results were also mixed for studies evaluating the effect of weight loss on fasting plasma glucose levels. Two studies reported correlations between weight loss measures [%TBL (r= 0.161, P<0.001) 3 and change in WC (r= 0.35, P=0.04) 12 )] and change in fasting glucose; however, another study reported no association between %EWL and fasting glucose (r= , P=0.625). 17 Similarly, the correlation between loss of visceral fat and decreased fasting glucose levels was reported in one study (r= 0.211, P=0.0339) 13 but not in another study (r= 0.35, P=0.06). 4 In a study by Conroy et al., the relationship between weight loss and fasting glucose levels differed by presence of the metabolic syndrome. 5 Among patients in this study with metabolic syndrome, an inverse correlation between change in fasting glucose levels and %TBL and change in BMI was reported at 6 months follow-up (nr, P=0.019 and P=0.013, respectively) and at 12 months follow-up (nr, P=0.046 and P=0.037, respectively). In contrast, none of these relationships were present in patients with metabolic syndrome. Results were generally more consistent for the relationship between weight loss and fasting plasma insulin. Changes in BMI (r= 0.341, P= ; and nr, P< ), WC (r= 0.356, P=0.0001) 13, and visceral fat (r= 0.268, P= ; and r=0.46, P= ) were all correlated with changes in insulin levels after LAGB surgery. Moreover, the decrease in fasting insulin remained related to visceral fat loss after adjusting for age and sex (nr, P 0.001). 4 In the same study, however, total weight loss was not correlated with changes in fasting insulin (nr, P>0.05). 4 Weight loss was also largely associated with improved insulin sensitivity measures. Changes in body weight (r= -0.46, P<0.05) 11 and BMI (r= -0.48, P< ; and r=-0.43, P< ) were inversely correlated with change in insulin sensitivity. In addition, %EWL was correlated with higher HOMA %S (r= 0.28, P= ; r= 0.47, P< ; and r= 0.47, P= ) and independently associated with improved beta cell function (as indicated by higher HOMA %β levels) after controlling for a change in HOMA %S (r= -0.43, P<0.001). 7 In addition, %EWL (r= , P<0.0001) 2, changes in BMI (r= 0.283, P=0.0001; 13 and nr, P< ), WL (r= , a nr = test statistic not reported 4

5 P<0.0001) 2, and WC (r= 0.305, P=0.0001) 13 were correlated with changes in HOMA-IR. Reduced visceral fat was also associated with changes in HOMA-IR (r= 0.49, P= ; and r= 0.287, P= ). Moreover, reductions in HOMA-IR remained related to visceral fat loss after adjusting for age and sex (nr, P 0.001). 4 Total weight loss, however, was not correlated with changes in HOMA-IR (nr, P>0.05) Hypertension Four observational studies evaluated the impact of weight loss from LAGB on hypertension. In all four studies, measures of weight change were not related to changes in systolic blood pressure (SBP) or diastolic blood pressure (DBP). 3, 6, 12, 17 More specifically, %TBL (r= 0.044, P>0.05) 3, %EWL (nr, P> ; and r= , P= ), and changes in BMI (nr, P>0.05) 12, WC (nr, P>0.05) 12, and HC (nr, P>0.05) 12 were not correlated with changes in SBP after LAGB placement. Similarly, %TBL (r= 0.040, P>0.05) 3, %EWL (nr, P> ; and r= , P= ) and changes in BMI (nr, P>0.05) 12, total body fat mass (r= 0.41, P>0.05) 6, WC (nr, P>0.05) 12, and HC (nr, P>0.05) 12 were also not correlated with change in DBP. 3. Dyslipidemia Nine observational studies assessed the effect of weight loss from LAGB on dyslipidemia. These studies utilized measurement of one or more of the following lipid biomarkers: triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol (TC). Various measures of weight loss were correlated with lower TG levels, including %TBL (r= 0.172, P< ; nr, P= ) and changes in body weight (r= 0.16, P<0.05) 11, BMI (r= 0.14, P<0.05) 11, WC (r= 0.231, P=0.0017) 13, and visceral fat (r= 0.226, P=0.0216) 13. In the study by Busetto et al., the correlation between %TBL and TG was statistically significant up to %TBL >25%. 3 On the other hand, there were also studies that reported no association between change in TG levels and weight loss as measured by %EWL (r= -0.09, P= ; r= -0.24, P= ; nr, P> ; and r= , P= ) and changes in BMI (nr, P>0.05) 12, WC nr, P>0.05) 12, and HC (nr, P>0.05) 12. One study, however, did find a relationship between %EWL and TG after controlling for HOMA S% (r= -0.24, P=0.004). 9 A separate study that examined these relationships stratified by metabolic syndrome status also found correlations between weight loss (as assessed by %TBL and change in BMI) and a reduction in TG levels among patients without metabolic syndrome (nr, P=0.01 and nr, P=0.004, respectively), but not among those with the syndrome (nr, both P>0.05). 5 Measures of weight loss were related to higher HDL levels, including %TBL (r= , P< and nr, P= ), %EWL (r= 0.45, p= and nr, P= ), and changes in BMI (r= , P=0.0328) 13 and subcutaneous fat depots (r= , P=0.0138) 13. A correlation between %TBL and HDL up to %TBL >25% was reported by Busetto et al., 3 indicating that improvement in HDL level is largely present in those losing the most weight. However, there were also studies that reported that %EWL (r= 0.13, p= and nr, P> ) and changes in BMI (nr, P>0.05) 12, WC (nr, P>0.05) 12, and HC (nr, P>0.05) 12 were not associated with a change in HDL after receiving LAGB. 5

6 Only one study examined the effect of weight loss on LDL cholesterol levels. A study by Dixon et al. reported a negative correlation between %EWL and LDL cholesterol (r= -0.25, P=0.002), a relationship that remained statistically significant even after adjusting for HOMA %S (r= -0.20, P=0.01). 9 The same study by Dixon et al. also reported an association between %EWL and TC (r= -0.18, P=0.02), which remained even after adjusting for HOMA %S (r= -0.20, P=0.014). 9 However, other studies reported no correlations between change in TC and weight loss, as measured by %TBL (r= 0.070, P>0.05) 3, %EWL (nr, P> and r= 0.347, P= ), and changes in BMI (nr, P>0.05) 12, WC (nr, P>0.05) 12, HC (nr, P>0.05) 12, and fat mass (r= 0.36, P>0.05) Studies that Assessed All 3 Comorbidities There were 3 studies that assessed all three conditions of interest. 3, 12, 17 As previously noted, all 3 studies reported no association between weight loss and changes in blood pressure. However, with regard to diabetes and dyslipidemia, the findings were mixed. One study reported correlations between weight loss and both conditions of interest 3, one study found a correlation between weight loss and diabetes but not dyslipidemia 12, and one study reported no correlation between weight loss and neither condition of interest 17. C. Safety Among the included studies, only 6 reported having post-operative complications/adverse events 1, 5, 6, 8, 10, 17, one study reported having no deaths 2, and the remaining 10 did not report whether or not any complications or adverse events occurred 3, 4, 7, 9, In all, no deaths were reported in any study. Among the 553 patients in the 6 studies reporting, post-operative complications and adverse events that may or may not be attributed to the LAGB device included: 13 patients with band displacements requiring repositioning 5, 10, 17, 12 patients needing revisions for stomach prolapse/enlargement 1, 8, 6 patients with wound complications (including infections) 5, 8, 17, 5 patients with port repositionings 5, 3 patients with band erosions requiring replacement 8, 3 patients with recurrent band slippage requiring removal 10, 3 revisions for unknown reasons 6, and 2 patients with tube leaks 8. Single cases were also reported for each of the following events: exploration for bleeding 5, exploration for presumed bowel obstruction (determined to be prolonged ileus) 5, aggravation of plantar fasciitis 5, need for respiratory support 8, pulmonary embolism 10, febrile episode 1, hypoglycemic episode 1, gastrointestinal intolerance to metformin 1, band removal for eating difficulties 1, replacement of leaking port 10, and band puncture 17. D. Discussion of Strengths and Limitations A notable strength of the studies included in this review was the utilization of linear or logistic regression modeling to evaluate the effect of weight loss on the comorbidities of interest. With the exception of one study, objective markers were used to assess the comorbidity status. Fourteen studies also included or referenced strict inclusion and exclusion criteria that delineated how patients were selected for the gastric banding procedure. 6

7 However, there were a number of notable limitations. Of the 17 studies included in this systematic literature review, only one study had an RCT design and it was unmasked. The remaining sixteen studies had an observational study design, and of these, 12 studies did not have an intervention-based control group (single-arm study) 3, 5, 7-13, Moreover, all 17 studies were based on a single surgeon or institution experience, thus limiting the generalizability of the findings. As previously noted, sample size was generally small and follow-up duration was limited. IV. Conclusion In conclusion, most studies reported statistically significant correlations between weight loss and at least one biomarker associated with diabetes showing improvement/remission. With regard to dyslipidemia, results were mixed with some studies finding significant correlations between weight loss and lipid biomarkers while others reported no association. Lastly, weight loss was not found to be associated with improvements in hypertension in this systematic review of the literature. Nonetheless, information in the published literature regarding the long-term effectiveness of LAGB and whether sustained weight loss leads to sustained reductions in cardiometabolic risk is limited. Future studies with longer follow-up periods and larger sample sizes therefore are necessary to further clarify these issues. VI. Attachments Figure 1: Inclusion and exclusion of articles from literature search 7

8 Figure 1. Article Retrieval and Selection Records identified through electronic database searches (n =776) Pubmed/MEDLINE n=321 Embase n=407 CINAHL n=48 # of articles when duplicates removed (n = 549) Titles and abstracts reviewed Records excluded: (n=350) Non-clinical study (n=111) Case report (n=54) Non-human study (n=6) Does not study lap band device (n=91) Research question or outcomes not relevant (n=60) Does not address all 3 domains (n=22) Does not evaluate impact of weight loss on conditions of interest (n=6) (n = 549) Full-text articles assessed for eligibility (n =199) Studies included in qualitative synthesis (n =17) Full-text articles excluded: (n=182) Case series with n 20 (n=35) Non-systematic literature review (n=8) Conference proceeding (n=1) Does not evaluate impact of weight loss on conditions of interest (n=99) No weight loss or condition of interest data (n=10) Analysis not stratified by bariatric procedure type (n=7) Research question or outcomes not relevant (n=22) 8

9 References 1. Dixon JB, O'Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA: Journal of the American Medical Association. 2008;299(3): Ballantyne GH, Wasielewski A, Saunders JK. The surgical treatment of type II diabetes mellitus: Changes in HOMA insulin resistance in the first year following laparoscopic roux-en-y gastric bypass (LRYGB) and laparoscopic adjustable gastric banding (LAGB). Obesity Surgery. 2009;19(9): Busetto L, Sergi G, Enzi G, et al. Short-term effects of weight loss on the cardiovascular risk factors in morbidly obese patients. Obes Res. Aug 2004;12(8): Carroll JF, Franks SF, Smith AB, Phelps DR. Visceral adipose tissue loss and insulin resistance 6 months after laparoscopic gastric banding surgery: A preliminary study. Obesity Surgery. 2009;19(1): Conroy R, Lee E, Jean A, et al. Effect of laparoscopic adjustable gastric banding on metabolic syndrome and its risk factors in morbidly obese adolescents. Journal of Obesity.8p. 6. Dittmar M, Heintz A, Hardt J, Egle UT, Kahaly GJ. Metabolic and psychosocial effects of minimal invasive gastric banding for morbid obesity. Metabolism: Clinical and Experimental. 2003;52(12): Dixon JB, Dixon AF, O'Brien PE. Improvements in insulin sensitivity and (beta)-cell function (HOMA) with weight loss in the severely obese. Diabetic Medicine. 2003;20(2): Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25(2): Dixon JB, O'Brien PE. Lipid profile in the severely obese: changes with weight loss after lap-band surgery. Obes Res. Sep 2002;10(9): Dolan K, Bryant R, Fielding G. Treating diabetes in the morbidly obese by laparoscopic gastric banding. Obesity Surgery. 2003;13(3): Gastaldelli A, Perego L, Paganelli M, et al. Elevated concentrations of liver enzymes and ferritin identify a new phenotype of insulin resistance: Effect of weight loss after gastric banding. Obesity Surgery. 2009;19(1): Gasteyger C, Suter M, Calmes JM, Gaillard RC, Giusti V. Changes in body composition, metabolic profile and nutritional status 24 months after gastric banding. Obesity Surgery. 2006;16(3): Pontiroli AE, Frige F, Paganelli M, Folli F. In morbid obesity, metabolic abnormalities and adhesion molecules correlate with visceral fat, not with subcutaneous fat: Effect of weight loss through surgery. Obesity Surgery. 2009;19(6): Pontiroli AE, Pizzocri P, Librenti MC, et al. Laparoscopic adjustable gastric banding for the treatment of morbid (grade 3) obesity and its metabolic complications: A three-year study. Journal of Clinical Endocrinology and Metabolism. 2002;87(8): Segato G, Busetto L, De Luca M, et al. Weight loss and changes in use of antidiabetic medication in obese type 2 diabetics after laparoscopic gastric banding. Surgery for Obesity and Related Diseases.6(2):

10 16. Sesti G, Folli F, Perego L, Hribal ML, Pontiroli AE. Effects of weight loss in metabolically healthy obese subjects after laparoscopic adjustable gastric banding and hypocaloric diet. PLoS ONE.6(3). 17. Singhal R, Kitchen M, Bridgwater S, Super P. Metabolic outcomes of obese diabetic patients following laparoscopic adjustable gastric banding. Obesity Surgery. 2008;18(11):

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