RANDOMIZED CLINICAL STUDY COMPARING THE EFFECT OF ROUX-en-Y GASTRIC BYPASS AND SLEEVE GASTRECTOMY ON REACTIVE HYPOGLYCEMIA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- incidence reactive hypoglycemia
Study Overview
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.
Detailed Description
INTRODUCTION Geltrude Mingrone,Simona Panunzi, Andrea De Gaetano, Caterina Guidone, Celestino Pio Lombardi, Marco Raffaelli,Rocco Bellantone Departments of Internal Medicine, Surgery and Biomathematics of the Catholic University of Rome, Italy
The overall prevalence of grade 2 and 3 adult obesity (BMI> 35 kg/m2) derived from the 2009-2010 National Health and Nutrition Examination Survey (NHANES) exceeded 15% and grade 3 obesity (BMI > 40 kg/m2) accounted for 6.3% (1). The dietary approach is modestly satisfactory in the short term and weight regain is practically the rule in the long run as a consequence of the scarce compliance to the diet shown by the obese subjects. In fact, in a recent study (2) where different types of diets were assigned to a population of overweight and obese subjects (BMI from 25 to 40 kg/m2), an average of 6 kg, corresponding to 7% of the initial body weight, was lost in the first 6 months, but the weight was regained after 1 year and at 2 years, only 31-37% of the participants had lost 5% of their initial weight.
Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2 obesity associated with complications (3) and, accordingly, the number of bariatric operations in the United States is growing over time from ca. 10,000 in the early 1990s to 103,000 in 2003 (4).
Bariatric surgery allows to type 2 diabetes remission (5,6) while improving several other serious comorbidities (7). 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 (8). 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 (9), has recently emerged as a new restrictive bariatric procedure (10). It was noticed that SG determines a weight loss similar to that achieved after RYGB (11) and larger than that following laparoscopic adjustable gastric banding (12,13).
Reactive hypoglycemia is a late complication of RYGB although it seems to occur also after SG.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- 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.
Outcomes
Primary Outcomes
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 Outcomes
- insulin resistance(0,1,3,6,9, and 12 months)
Investigators
Geltrude Mingrone
Associate Professor of Internal Medicine
Catholic University of the Sacred Heart