Obesity With Complications | Bariatric Surgery and Reactive Hypoglycemia
Obesity With Complications research study
What is the primary objective of this study?
Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2 obesity associated with complications. Among the bariatric surgical procedures, roux-en-y gastric bypass (RYGB) was shown to account for 41% of all bariatric operations at least in the United Sates. Sleeve gastrectomy (SG), that was conceived as the first step before performing a RYGB or a biliopancreatic diversion with duodenal switch in patients who were super-obese, has recently emerged as a new restrictive bariatric procedure. Reactive hypoglycemia is a late complication affecting up to 72% of RYGB patients although it seems to occur also after SG, in about 3% of the cases. However, until now no prospective studies have investigated the incidence of hypoglycemia after RYGB nor randomized studies have been undertaken to compare the effect of SG to that of RYGB in terms of incidence of hypoglycemic episodes. The primary aim of the present study is to conduct a 1-year randomized trial to compare the incidence of hypoglycemia after RYGB or SG.
Who is eligible to participate?
Inclusion Criteria: - Patients are eligible if aged between 25 and 65 years, have a body mass index of 35 (in presence of complications as sleep apnea, severe coxarthritis or gonarthritis, severe hypertension) to 50 kg/m2, and are able to understand and comply with the study process. Exclusion Criteria: - History of type 1 diabetes or secondary diabetes; - Previous bariatric surgery; - History of medical problems such as mental impairment; - Major cardiovascular disease; - Major gastrointestinal disease; - Major respiratory disease; - Hormonal disorders; - Infection; - History of drug addiction and/or alcohol abuse; - Internal malignancy; - Pregnancy; - Impaired glucose tolerance; - Suspected or confirmed poor compliance; - Informed consents.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Obesity With Complications
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Gastric BypassRoux-en-Y Gastric Bypass This laparoscopic operation includes the division of the stomach in two parts. A proximal, smaller pouch (20-25 cc volume), is connected to the rest of the gastrointestinal tract through a gastro-jejunal anastomosis, whereas the distal gastric pouch is left behind but excluded from the transit of food. An entero-entero anastomosis, with a Roux-en-Y type of reconstruction, allows the bile and pancreatic juices to mix with the nutrients at about 100-150 cm from the gastro-jejunal connection.
Procedure:Sleeve GastrectomySleeve gastrectomy Laparoscopic SG involves a longitudinal resection of the stomach on the greater curvature from the antrum starting opposite of the nerve of Latarjet up to the angle of His The final gastric volume is about 100 mL.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Gastric Bypass60 subjects obese subjects with complications or morbidly obese subjects will be assigned randomly to this arm to undergo gastric bypass
Sleeve Gastrectomy60 subjects obese subjects with complications or morbidly obese subjects will be assigned randomly to this arm to undergo sleeve gastrectomy
Start Date: October 2012
Completed Date: March 2016
Primary Outcome: incidence reactive hypoglycemia
Secondary Outcome: insulin resistance
Study sponsors, principal investigator, and references
Principal Investigator: Geltrude Mingrone, MD
Lead Sponsor: Catholic University of the Sacred Heart
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.