Clinical trial NCT03111953: Effect of Biliopancreatic Diversion on Glucose Homeostasis
Official title: Effect of Biliopancreatic Diversion on Glucose Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: Bariatric Surgery
Roux-en-Y gastric bypass
Biliopancreatic Diversion
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
name: The Foundation for Barnes-Jewish Hospital
First posted: 2017-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: 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
timeFrame: Change from Baseline up to a possible 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Geltrude Mingrone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.