1. comparison between pre- and postoperative serum levels incretines and bile acids (after RYGB).2. comparison between S-RYGB and LBPL-RYGB with respect to incretines and bile acids.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pre- and postoperative (after 4 weeks) measurement of incretin and bile acid
concentration in patients that undergo a RYGB (S-RYGB and LBPL-RYGB)
Secondary outcome
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Background 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 (LBPL-RYGB: AL of 75cm and a BPL of
150cm). Not yet published outcomes of this study showed 10% more excess weight
loss (EWL) in favour of the LBPL-RYGB after 12 months follow-up. Additionally,
the LBPL-RYGB might have a slight advance on reduction of T2DM and the number
of complications are comparable.
However, 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.
We hypothesize that incretin and bile acid levels are different between
patients receiving a S-RYGB and LBPL-RYGB.
Study objective
1. comparison between pre- and postoperative serum levels incretines and bile
acids (after RYGB).
2. comparison between S-RYGB and LBPL-RYGB with respect to incretines and bile
acids.
Study design
A prospective randomized trial in which incretine and bile acid concentrations
will be measured.
Study burden and risks
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Wagnerlaan 55
Arnhem 6800TA
NL
Wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51154.091.14 |