Effect of Biliopancreatic Diversion on Glucose Homeostasis

Obesity, Morbid Clinical Trial

— BPD-Mingrone  

Official title:

Effect of Biliopancreatic Diversion on Glucose Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111953
• Other study ID #: 411/14
• Status: Completed
• Phase: N/A
• First received: March 13, 2017
• Last updated: April 7, 2017
• Start date: January 9, 2014
• Est. completion date: June 28, 2016

Study information

• Verified date: April 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 28, 2016
• Est. primary completion date: June 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• Roux-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.
• Biliopancreatic 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.

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Catholic University of the Sacred Heart, Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change from Baseline up to a possible 9 months