Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Biliopancreatic Diversion on Glucose Homeostasis (BPD-Mingrone)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03111953
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborators:
Catholic University of the Sacred Heart
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: Roux-en-Y Gastric Bypass Surgery Procedure: Biliopancreatic Diversion Surgery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Biliopancreatic Diversion on Glucose Homeostasis
Actual Study Start Date : January 9, 2014
Actual Primary Completion Date : June 28, 2016
Actual Study Completion Date : June 28, 2016

Arm Intervention/treatment
Active Comparator: RYGB
Subjects received Roux-en-Y Gastric Bypass surgery.
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.

Experimental: BPD
Subjects received Biliopancreatic Diversion Surgery
Procedure: 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.




Primary Outcome Measures :
  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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111953


Locations
Layout table for location information
Italy
Catholic University of the Sacred Heart
Rome, Italy, 00128
Sponsors and Collaborators
Washington University School of Medicine
Catholic University of the Sacred Heart
Barnes-Jewish Hospital
Investigators
Layout table for investigator information
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
Principal Investigator: Geltrude Mingrone, MD, PhD Catholic University of the Sacred Heart

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03111953     History of Changes
Other Study ID Numbers: 411/14
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Bariatric Surgery
Roux-en-Y gastric bypass
Biliopancreatic Diversion
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms