Effect of Biliopancreatic Diversion on Glucose Homeostasis

NCT ID: NCT03111953

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-09
• Study Completion Date: 2016-06-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

RYGB

Subjects received Roux-en-Y Gastric Bypass surgery.

Group Type: ACTIVE_COMPARATOR

Roux-en-Y Gastric Bypass Surgery

Intervention Type: 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.

BPD

Subjects received Biliopancreatic Diversion Surgery

Group Type: EXPERIMENTAL

Biliopancreatic Diversion Surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Geltrude Mingrone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

Catholic University of the Sacred Heart

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32994312 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31588013 (View on PubMed)

Other Identifiers

411/14

Identifier Type: -

Identifier Source: org_study_id