Bariatric Surgery and Reactive Hypoglycemia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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: | January 2014 |
| Estimated Primary Completion Date: | September 2013 (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 |
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| Contact: Geltrude Mingrone, MD | 00390630154395 | gmingrone@rm.unicatt.it |
| Contact: Caterina Guidone, MD | 00390630155323 | caterinaguidone@gmail.com |
| Italy | |
| Catholic University School of Medicine | Recruiting |
| Rome, Italy, 00168 | |
| Contact: Geltrude Mingrone, MD 00390630154395 gmingrone@rm.unicatt.it | |
| Principal Investigator: Geltrude Mingrone, MD | |
| 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: | October 8, 2012 |
| 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 Glucose Metabolism Disorders Metabolic Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013