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

Sponsor

Rijnstate Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03384303

Collaborator

University College Dublin (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Other: Standardized meal test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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