Bariatric Surgery and Reactive Hypoglycemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01581801
First received: April 19, 2012
Last updated: March 31, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • incidence reactive hypoglycemia [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gastric Bypass
25 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
25 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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581801

Contacts
Contact: Geltrude Mingrone, MD 00390630154395 gmingrone@rm.unicatt.it
Contact: Caterina Guidone, MD 00390630155323 caterinaguidone@gmail.com

Locations
Italy
Catholic University School of Medicine Recruiting
Rome, Italy, 00168
Contact: Geltrude Mingrone, MD    00390630154395    gmingrone@rm.unicatt.it   
Principal Investigator: Geltrude Mingrone, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Geltrude Mingrone, MD Catholic University, Italy
  More Information

Publications:

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
Study First Received: April 19, 2012
Last Updated: March 31, 2014
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014