NCT03384303

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

Completed NA Last updated 27 December 2017

What this trial tests

NA trial testing Standardized meal test in Morbid Obesity in 10 participants. Completed in 1 May 2016.

Timeline

1 October 2015

Primary endpoint
1 May 2016

1 May 2016

Quick facts

Lead sponsor	Rijnstate Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	10
Start date	1 October 2015
Primary completion	1 May 2016
Estimated completion	1 May 2016

Drugs / interventions tested

• Standardized meal test

Conditions studied

• Morbid Obesity — all drugs for Morbid Obesity →

Sponsor

Rijnstate Hospital

Who can join

18 and older, female only, with Morbid Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.