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1.
Endosc Int Open ; 12(2): E253-E261, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38415023

ABSTRACT

Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons ( P <0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases ( P <0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists ( P <0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists ( P >0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.

2.
Clin Transl Gastroenterol ; 15(1): e00647, 2024 01 01.
Article in English | MEDLINE | ID: mdl-37787450

ABSTRACT

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) has gained popularity over the past decade and has been adopted in both academic and private institutions globally. We present outcomes of the largest cohort of patients from the United States undergoing ESG and evaluate these according to obesity class. METHODS: We performed a retrospective analysis of adult patients who underwent ESG. Medical information was abstracted from the electronic record with weight records up to 2 years after ESG. Percent total body weight loss (%TBWL) at 6, 12, 18, and 24 months was calculated based on baseline weight at the procedure. SPSS (version 29.0) was used for all statistical analyses. RESULTS: A total of 1,506 patients from 7 sites were included (501 Class I obesity, 546 Class II, and 459 Class III). Baseline demographics differed according to obesity class due to differences in age, body mass index (BMI), height, sex distribution, and race. As early as 6 months post-ESG, mean BMI for each class dropped to the next lower class and remained there through 2 years. %TWBL achieved in the Class III group was significantly greater when compared with other classes at all time points. At 12 months, 83.2% and 60.9% of patients had ≥10% and ≥15% TBWL for all classes. There were no differences in adverse events between classes. DISCUSSION: Real-world data from a large cohort of patients of all BMI classes across the United States shows significant and sustained weight loss with ESG. ESG is safe to perform in a higher obesity class with acceptable midterm efficacy.


Subject(s)
Gastroplasty , Adult , Humans , United States/epidemiology , Gastroplasty/adverse effects , Gastroplasty/methods , Retrospective Studies , Treatment Outcome , Obesity/epidemiology , Obesity/surgery , Endoscopy
3.
Gastrointest Endosc ; 99(3): 371-376, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37852330

ABSTRACT

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.


Subject(s)
Gastroplasty , Obesity, Morbid , Humans , Adult , Middle Aged , Gastroplasty/methods , Overweight/surgery , Overweight/etiology , Treatment Outcome , Obesity/surgery , Endoscopy/methods , Weight Loss , Obesity, Morbid/surgery
4.
Diabetes Technol Ther ; 12(3): 173-7, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20151766

ABSTRACT

OBJECTIVE: This study determined the optimal timing of insulin bolus administration in relation to meal consumption in adolescents and adults with type 1 diabetes. STUDY DESIGN AND METHODS: Twenty-three subjects participated in this crossover study consisting of three treatment arms: delivering an insulin glulisine bolus by insulin pump 20 min prior to a meal ("PRE"), immediately before the meal ("START"), and 20 min after meal initiation ("POST"). Blood glucose levels were measured every 30 min for a total of 240 min post-meal initiation. Mean blood glucose levels at 1 and 2 h after meal initiation, blood glucose area under the curve (AUC), and maximum blood glucose levels were analyzed. RESULTS: At both 60 and 120 min after meal initiation, the PRE arm showed significantly lower glycemic excursions than the START arm (P = 0.0029 and 0.0294, respectively) and the POST arm (P = 0.001 and 0.0408, respectively). Glycemic AUC was significantly less in the PRE arm versus both the START and POST arms (159.5 +/- 58.9 mg/dL vs. 187.0 +/- 43.1 mg/dL [P = 0.0297] and 184.5 +/- 33.2 mg/dL [P = 0.0463], respectively). Peak blood glucose levels were significantly lower in the PRE arm compared to the START arm (P = 0.0039) and the POST arm (P = 0.0027). CONCLUSIONS: A bolus of rapid-acting insulin 20 min prior to a meal results in significantly better postprandial glucose control than when the meal insulin bolus is given just prior to the meal or 20 min after meal initiation.


Subject(s)
Blood Glucose/drug effects , Diabetes Mellitus, Type 1/drug therapy , Insulin/analogs & derivatives , Adolescent , Adult , Child , Colorado , Cross-Over Studies , Diabetes Mellitus, Type 1/blood , Drug Administration Schedule , Female , Humans , Hyperglycemia/drug therapy , Insulin/administration & dosage , Insulin Infusion Systems , Male , Self Care/methods , Young Adult
5.
Diabetes Care ; 33(3): 507-8, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20032279

ABSTRACT

OBJECTIVE To evaluate the effects of missed insulin boluses for snacks in youth with type 1 diabetes. RESEARCH DESIGN AND METHODS Three months of simultaneous continuous subcutaneous insulin infusion and continuous glucose monitoring data from nine subjects were retrospectively evaluated. Glucose excursions between 1330 and 1700 h were defined as relating to snacks with insulin or snacks with no insulin administered. Area under the curve >180 mg/dl (AUC >180), average Delta glucose, and rate of change were analyzed and compared within and between groups. RESULTS A total of 94 snacks without insulin and 101 snacks with insulin were analyzed. Snacks without insulin had significantly higher log (AUC >180 + 1) (1.26 vs. 0.44 mg/dl per event; P < 0.001), Delta glucose (114 vs. 52 mg/dl; P < 0.001), and average rate of change (1.3 vs. 1.1 mg/dl per minute; P < 0.001). CONCLUSIONS This study shows that afternoon snacks without insulin boluses are common and result in significantly higher glucose excursions than snacks with insulin administration.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Eating/physiology , Insulin/administration & dosage , Adolescent , Adult , Blood Glucose/metabolism , Child , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/metabolism , Dietary Carbohydrates/administration & dosage , Drug Administration Schedule , Female , Humans , Insulin Infusion Systems , Male , Patient Compliance , Retrospective Studies , Time Factors , Young Adult
6.
Diabetes Technol Ther ; 11 Suppl 1: S83-91, 2009 Jun.
Article in English | MEDLINE | ID: mdl-19469682

ABSTRACT

Continuous glucose monitoring (CGM) is becoming increasingly popular and represents the third era of diabetes management. Currently available CGM devices have been studied in youth with type 1 diabetes and show similar accuracy across all age groups. Tolerability of these devices relates to alarm settings, sensor skin irritation, and durability of the device. Youth will be most successful on a CGM regimen if they have a personal investment in wearing the CGM device and have a stable support system for their diabetes care. Data indicate that glycemic control improves the most in youth who wear CGM devices >or=5 days per week, allowing for the ability to make more insulin dose changes. CGM has proven useful in alerting youth to hypoglycemia and may be a valuable tool with exercise. Further studies are needed to assess the utility of CGM for prevention of severe hypoglycemic events and increasing time spent in euglycemia. Fear of hypoglycemia may be ameliorated with CGM use; however, the potential for increased stress in families with continuous feedback must also be considered. In the future, CGM use in youth may couple with insulin pump technology to create a "closed-loop" system in which the CGM device will direct insulin administration without user input.


Subject(s)
Blood Glucose/analysis , Diabetes Mellitus, Type 1/blood , Monitoring, Ambulatory/methods , Adolescent , Blood Glucose/metabolism , Diabetes Mellitus, Type 1/psychology , Glycated Hemoglobin/metabolism , Glycosuria/urine , Humans , Hypoglycemia/chemically induced , Hypoglycemia/prevention & control , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Insulin/adverse effects , Insulin/therapeutic use , Monitoring, Ambulatory/psychology
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