Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric Bypass

Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric

Obesity is an increasing world wide problem. Moreover, the increase in patients who are considered morbidly obese is even higher (Sturm et al, Healt Aff 2004). Conservative approaches such as diets or medication are unsuccessful in the majority of the patients. Additionally, (morbid) obesity leads often to cardiovascular diseases, such as hypertension, dyslipidemia and type 2 diabetes (T2DM). When patients need insulin to regulate their glucose levels, their weight is even more difficult to control. Therefore, bariatric procedures are increasingly performed, with over 8.000 procedures in the Netherlands in 2013. The two most performed types of bariatric surgery in the Netherlands are the Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and the Laparoscopic Sleeve Gastrectomy (LSG). Within the LRYGB there are different variants available. In a recently initiated randomized controlled trial (RCT) from our centre, a comparison between two variants of RYGB was performed. In this RCT our standard RYGB (s-RYGB:alimentary limb (AL) of 150cm; biliopancreatic limb (BPL) of 75cm) was compared with a RYGB with an long BPL (LBPLRYGB:AL of 75cm and a BPL of 150cm). A LBPLRYGB might improve weight loss and reduction after surgery. The exact mechanism of action is still not fully understood. Stomach volume is decreased and satiety levels often increase, probably due to changes in incretin levels. Passage of foods through the gastrointestinal tract are altered after RYGB. A possible explanation might be found in different levels of incretins (such as GLP-1, PYY and ghrelin) and bile acids (FGF-19 and FGF-21) after bariatric surgery.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Other: Standardized meal test

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• General guidelines for bariatric surgery according to Fried (Fried et al, Obes Surg 2007).
• Age > 18 years
• Patients must be able to adhere to the study visit schedule and protocol requirements
• Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
• Patients who are planned for a LRYGB

Exclusion Criteria:

• Binge-eating or associated eating disorder
• Active drug or alcohol addiction
• Pregnancy and when giving breast feeding
• A medical history of bariatric surgery
• Patients with a language barrier which can inhibit patients to follow the correct medical advice
• Any kind of genetic disorder that can inhibit patients to follow the correct medical advice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: LBPL-RYGB	Other: Standardized meal test; Preoperatively and postoperatively standardized meal test
OTHER: S-RYGB	Other: Standardized meal test; Preoperatively and postoperatively standardized meal test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline incretine levels during a standardized meal test four weeks after surgery.	Preoperatively and four weeks after surgery
Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.	Preoperatively and four weeks after surgery
Change from baseline bile acid levels during a standardized meal test four weeks after surgery.	Preoperatively and four weeks after surgery

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: University College Dublin

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (ACTUAL): December 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Bariatric surgery; Gastric bypass; Gut hormones; Bile acids; Incretines; Limb lengths; Biliopancreatic limb
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2014-1359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No