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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Obesity With Complications Morbid Obesity Reactive Hypoglycemia Bariatric Surgery Procedure: Gastric Bypass Procedure: Sleeve Gastrectomy

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : October 2012
Primary Completion Date : March 2015
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.



Eligibility Criteria

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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:

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 Posted: April 20, 2012    Key Record Dates
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