Obesity, Morbid
Conditions
Keywords
Bariatric Surgery, Roux-en-Y gastric bypass, Biliopancreatic Diversion
Brief summary
Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than all other bariatric surgical procedures, and it is hypothesized that this procedure has specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in Rome, Italy. The purpose of this study is to provide a better understanding of the effect of the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It is hypothesized that weight loss achieved with BPD surgery will have greater effects on insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric bypass (RYGB).
Interventions
PROCEDURERoux-en-Y Gastric Bypass Surgery
In Roux-en-Y Gastric Bypass Surgery a small gastric pouch is created and connected to a segment of jejunum. Bowel continuity is restored by reconnecting the Roux limb and the biliopancreatic limb approximately \ 75-150 cm distal to the gastrojejunostomy. Therefore, ingested food bypasses most of the stomach, the entire duodenum, and a short segment of the jejunum.
PROCEDUREBiliopancreatic Diversion Surgery
In Biliopancreatic Diversion Surgery a horizontal gastrectomy is conducted leaving a portion of the stomach, which is connected to the small intestine, \ 250 cm from the ileocecal valve and the biliopancreatic limb is connected to the ileum, \ 50 cm from the ileocecal valve. Digestive secretions from the biliopancreatic limb mix in the common channel, where ingested food is also delivered by the alimentary limb.
Sponsors
Catholic University of the Sacred Heart
The Foundation for Barnes-Jewish Hospital
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) ≥ 35 kg/m² * Undergoing either the RYGB or the BPD procedure. * Able to provide informed consent to participate in the research study
Exclusion criteria
* Weight \> 450 pounds * Smoke \> 7 cigarettes per day * Previous malabsorptive or restrictive intestinal surgery * Pregnant or breastfeeding * Inflammatory intestinal disease * Diabetes * Unstable dose of medications in the last 4 weeks before the pre-surgery metabolic studies * Severe organ dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in skeletal muscle insulin sensitivity will be assessed using the Hyperinsulinemic-Euglycemic Clamp (HEC) procedure, before and after weight loss induced by either BPD or RYGB surgery | Change from Baseline up to a possible 9 months | Insulin sensitivity: The HEC procedure will be used to evaluate insulin sensitivity before and after 20% weight loss induced by either BPD or RYGB surgery |
Countries
Italy
Outcome results
None listed