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Bariatric Surgery and Reactive Hypoglycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581801
First Posted: April 20, 2012
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart
  Purpose

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 Intervention
Obesity With Complications Morbid Obesity Reactive Hypoglycemia Bariatric Surgery Procedure: Gastric Bypass Procedure: Sleeve Gastrectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RANDOMIZED CLINICAL STUDY COMPARING THE EFFECT OF ROUX-en-Y GASTRIC BYPASS AND SLEEVE GASTRECTOMY ON REACTIVE HYPOGLYCEMIA

Resource links provided by NLM:


Further study details as provided by Geltrude Mingrone, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 120
Study Start Date: October 2012
Study Completion Date: March 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gastric Bypass
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.

Sleeve Gastrectomy
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Italy
Catholic University School of Medicine
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Geltrude Mingrone, MD Catholic University, Italy
  More Information

Publications:
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.
Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
Gastrointestinal surgery for severe obesity. Consens Statement. 1991 Mar 25-27;9(1):1-20. Review.
Steinbrook R. Surgery for severe obesity. N Engl J Med. 2004 Mar 11;350(11):1075-9.
Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Apr 26;366(17):1577-85. doi: 10.1056/NEJMoa1200111. Epub 2012 Mar 26.
Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
Sjöström L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjöström CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93.
Livingston EH. The incidence of bariatric surgery has plateaued in the U.S. Am J Surg. 2010 Sep;200(3):378-85. doi: 10.1016/j.amjsurg.2009.11.007. Epub 2010 Apr 20.
Regan JP, Inabnet WB, Gagner M, Pomp A. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003 Dec;13(6):861-4.
Deitel M, Crosby RD, Gagner M. The First International Consensus Summit for Sleeve Gastrectomy (SG), New York City, October 25-27, 2007. Obes Surg. 2008 May;18(5):487-96. doi: 10.1007/s11695-008-9471-5.
Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. Epub 2007 Mar 14.
Himpens J, Dapri G, Cadière GB. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg. 2006 Nov;16(11):1450-6.
Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9.
Salinari S, Bertuzzi A, Guidone C, Previti E, Rubino F, Mingrone G. Insulin sensitivity and secretion changes after gastric bypass in normotolerant and diabetic obese subjects. Ann Surg. 2013 Mar;257(3):462-8. doi: 10.1097/SLA.0b013e318269cf5c.
Laferrère B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, Hart AB, Olivan B. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1709-16. Epub 2007 Apr 6.
Laferrère B, Teixeira J, McGinty J, Tran H, Egger JR, Colarusso A, Kovack B, Bawa B, Koshy N, Lee H, Yapp K, Olivan B. Effect of weight loss by gastric bypass surgery versus hypocaloric diet on glucose and incretin levels in patients with type 2 diabetes. J Clin Endocrinol Metab. 2008 Jul;93(7):2479-85. doi: 10.1210/jc.2007-2851. Epub 2008 Apr 22.
Service GJ, Thompson GB, Service FJ, Andrews JC, Collazo-Clavell ML, Lloyd RV. Hyperinsulinemic hypoglycemia with nesidioblastosis after gastric-bypass surgery. N Engl J Med. 2005 Jul 21;353(3):249-54.
Meier JJ, Nauck MA, Butler PC. Comment to: Patti ME, McMahon G, Mun EC et al. (2005) Severe hypoglycaemia post-gastric bypass requiring partial pancreatectomy: evidence for inappropriate insulin secretion and pancreatic islet hyperplasia. Diabetologia 48:2236-2240. Diabetologia. 2006 Mar;49(3):607-8; author reply 609-10. Epub 2006 Jan 31.
Edén Engström B, Burman P, Holdstock C, Ohrvall M, Sundbom M, Karlsson FA. Effects of gastric bypass on the GH/IGF-I axis in severe obesity--and a comparison with GH deficiency. Eur J Endocrinol. 2006 Jan;154(1):53-9.
Carpenter T, Trautmann ME, Baron AD. Hyperinsulinemic hypoglycemia with nesidioblastosis after gastric-bypass surgery. N Engl J Med. 2005 Nov 17;353(20):2192-4; author reply 2192-4.
Roslin M, Damani T, Oren J, Andrews R, Yatco E, Shah P. Abnormal glucose tolerance testing following gastric bypass demonstrates reactive hypoglycemia. Surg Endosc. 2011 Jun;25(6):1926-32. doi: 10.1007/s00464-010-1489-9. Epub 2010 Dec 24.
Tzovaras G, Papamargaritis D, Sioka E, Zachari E, Baloyiannis I, Zacharoulis D, Koukoulis G. Symptoms suggestive of dumping syndrome after provocation in patients after laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jan;22(1):23-8. doi: 10.1007/s11695-011-0461-7.
Marsk R, Jonas E, Rasmussen F, Näslund E. Nationwide cohort study of post-gastric bypass hypoglycaemia including 5,040 patients undergoing surgery for obesity in 1986-2006 in Sweden. Diabetologia. 2010 Nov;53(11):2307-11. doi: 10.1007/s00125-010-1798-5. Epub 2010 May 22.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geltrude Mingrone, Associate Professor of Internal Medicine, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01581801     History of Changes
Other Study ID Numbers: UCSC-2012-V01
2012-bariatric-001 ( Other Identifier: Catholic University )
First Submitted: April 19, 2012
First Posted: April 20, 2012
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Geltrude Mingrone, Catholic University of the Sacred Heart:
gastric bypass
sleeve gastrectomy
reactive hypoglycemia

Additional relevant MeSH terms:
Obesity
Hypoglycemia
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases


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