Bariatric Surgery and Reactive Hypoglycemia
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|ClinicalTrials.gov Identifier: NCT01581801|
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : February 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity With Complications Morbid Obesity Reactive Hypoglycemia Bariatric Surgery||Procedure: Gastric Bypass Procedure: Sleeve Gastrectomy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RANDOMIZED CLINICAL STUDY COMPARING THE EFFECT OF ROUX-en-Y GASTRIC BYPASS AND SLEEVE GASTRECTOMY ON REACTIVE HYPOGLYCEMIA|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2016|
60 subjects obese subjects with complications or morbidly obese subjects will be assigned randomly to this arm to undergo gastric bypass
Procedure: Gastric Bypass
Roux-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.
60 subjects obese subjects with complications or morbidly obese subjects will be assigned randomly to this arm to undergo sleeve gastrectomy
Procedure: Sleeve Gastrectomy
Sleeve 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.
- incidence reactive hypoglycemia [ Time Frame: up to 12 months ]The Primary Endpoint of the study is the incidence reactive hypoglycemia within 1 year after the bariatric surgery.
- insulin resistance [ Time Frame: 0,1,3,6,9, and 12 months ]
Changes at 1 year of insulin sensitivity and insulin secretion measured after an OGTT.
Changes at 1 year of body weight, BMI, abdominal circumference, body composition, lipid profile and cardiovascular system abnormalities.
the incidence of severe hypoglycemia or related symptoms (shakiness, sweating, dizziness or light-headedness, confusion, difficulty speaking, weakness, confusion, syncope, epilepsy, seizures) within 5 years after the operation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581801
|Catholic University School of Medicine|
|Rome, Italy, 00168|
|Principal Investigator:||Geltrude Mingrone, MD||Catholic University, Italy|