Effect of Biliopancreatic Diversion on Glucose Homeostasis

NCT03111953 | Completed

• 1 other identifier: 411/14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity, Morbid

Keywords

Bariatric Surgery; Roux-en-Y gastric bypass; Biliopancreatic Diversion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RYGB

ACTIVE COMPARATOR

Subjects received Roux-en-Y Gastric Bypass surgery.

Procedure: Roux-en-Y Gastric Bypass Surgery

BPD

EXPERIMENTAL

Subjects received Biliopancreatic Diversion Surgery

Procedure: Biliopancreatic Diversion Surgery

Interventions

Roux-en-Y Gastric Bypass Surgery PROCEDURE

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.

RYGB

Biliopancreatic Diversion Surgery PROCEDURE

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.

BPD

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Catholic University of the Sacred Heart: collaborator
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Catholic University of the Sacred Heart

Rome, 00128, Italy

Location

Related Publications (2)

• Angelini G, Salinari S, Castagneto-Gissey L, Bertuzzi A, Casella-Mariolo J, Ahlin S, Boskoski I, Gaggini M, Raffaelli M, Costamagna G, Casella G, Marini PL, Gastaldelli A, Bornstein S, Mingrone G. Small intestinal metabolism is central to whole-body insulin resistance. Gut. 2021 Jun;70(6):1098-1109. doi: 10.1136/gutjnl-2020-322073. Epub 2020 Sep 29.

  PMID: 32994312 DERIVED

• Harris LA, Kayser BD, Cefalo C, Marini L, Watrous JD, Ding J, Jain M, McDonald JG, Thompson BM, Fabbrini E, Eagon JC, Patterson BW, Mittendorfer B, Mingrone G, Klein S. Biliopancreatic Diversion Induces Greater Metabolic Improvement Than Roux-en-Y Gastric Bypass. Cell Metab. 2019 Nov 5;30(5):855-864.e3. doi: 10.1016/j.cmet.2019.09.002. Epub 2019 Oct 3.

  PMID: 31588013 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Geltrude Mingrone, MD, PhD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: April 13, 2017
• Study Start: January 9, 2014
• Primary Completion: June 28, 2016
• Study Completion: June 28, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)