Bariatric Surgery and Reactive Hypoglycemia

NCT01581801 | Completed DMC

• 2 other identifiers: UCSC-2012-V012012-bariatric-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity With Complications; Morbid Obesity; Reactive Hypoglycemia; Bariatric Surgery

Keywords

gastric bypass; sleeve gastrectomy; reactive hypoglycemia

Outcome Measures

Primary Outcomes (1)

• incidence reactive hypoglycemia

  The Primary Endpoint of the study is the incidence reactive hypoglycemia within 1 year after the bariatric surgery.

  up to 12 months

Secondary Outcomes (1)

• insulin resistance

  0,1,3,6,9, and 12 months

Study Arms (2)

Gastric Bypass

OTHER

60 subjects obese subjects with complications or morbidly obese subjects will be assigned randomly to this arm to undergo gastric bypass

Procedure: Gastric Bypass

Sleeve Gastrectomy

OTHER

60 subjects obese subjects with complications or morbidly obese subjects will be assigned randomly to this arm to undergo sleeve gastrectomy

Procedure: Sleeve Gastrectomy

Interventions

Gastric Bypass PROCEDURE

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.

Gastric Bypass

Sleeve Gastrectomy PROCEDURE

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.

Sleeve Gastrectomy

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University School of Medicine

Rome, 00168, Italy

Location

Related Publications (26)

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• Laferrere 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. doi: 10.2337/dc06-1549. Epub 2007 Apr 6.

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• 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.

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• 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.

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• Marsk R, Jonas E, Rasmussen F, Naslund 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.

  PMID: 20495972 BACKGROUND

• Grande R, Dovizio M, Marcone S, Szklanna PB, Bruno A, Ebhardt HA, Cassidy H, Ni Ainle F, Caprodossi A, Lanuti P, Marchisio M, Mingrone G, Maguire PB, Patrignani P. Platelet-Derived Microparticles From Obese Individuals: Characterization of Number, Size, Proteomics, and Crosstalk With Cancer and Endothelial Cells. Front Pharmacol. 2019 Jan 22;10:7. doi: 10.3389/fphar.2019.00007. eCollection 2019.

  PMID: 30723407 DERIVED

• Capristo E, Panunzi S, De Gaetano A, Spuntarelli V, Bellantone R, Giustacchini P, Birkenfeld AL, Amiel S, Bornstein SR, Raffaelli M, Mingrone G. Incidence of Hypoglycemia After Gastric Bypass vs Sleeve Gastrectomy: A Randomized Trial. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2136-2146. doi: 10.1210/jc.2017-01695.

  PMID: 29590421 DERIVED

• Mingrone G, Panunzi S, De Gaetano A, Guidone C, Raffaelli M, Callari C, Lombardi PC, Bellantone R. Protocol for a randomised clinical study comparing the effect of Roux-en-Y gastric bypass and sleeve gastrectomy on reactive hypoglycaemia in morbidly obese subjects. BMJ Open. 2012 Nov 19;2(6):e002184. doi: 10.1136/bmjopen-2012-002184. Print 2012.

  PMID: 23166141 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Hypoglycemia

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Geltrude Mingrone, MD

  Catholic University, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

IT (1)