Effect of Biliopancreatic Diversion on Glucose Homeostasis (BPD-Mingrone)
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|ClinicalTrials.gov Identifier: NCT03111953|
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Morbid||Procedure: Roux-en-Y Gastric Bypass Surgery Procedure: Biliopancreatic Diversion Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|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|
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.
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.
- 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
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
|Catholic University of the Sacred Heart|
|Rome, Italy, 00128|
|Principal Investigator:||Samuel Klein, MD||Washington University School of Medicine|
|Principal Investigator:||Geltrude Mingrone, MD, PhD||Catholic University of the Sacred Heart|