Bariatric Surgery Clinical Trial
Official title:
Endocrine and Absorptive Intestinal Function in Patients at Two Years of Bariatric Surgery: Omega Loop Gastric Bypass Versus Roux-en-Y Gastric Bypass
Gastric bypass with omega loop technic (OLGB) seems to be as effective as gastric bypass
roux-en-Y (RYGB the reference) for the management of obesity and type 2 diabetes, but with
less early surgical complications and more undernutrition in long terms.
This study aims to explore the profile of secretion of entero-insular hormone after a meal
test in OLGB patient vs RYGB to understand the mechanisms of the improvement of type 2
diabetes after OLGB.
Secondary objectives are to better understand the absorptive function of the gut after a
gastric bypass, to understand why is there more undernutrition in long term after OLGB than
after RYGB.
In the treatment of obesity associated with type 2 diabetes, there is still few informations
comparing the gastric bypass roux-en-Y (RYGB), the reference method, and the bypass in Omega
(OLGB). The effectiveness of both interventions is comparable regarding weight loss and the
management of type 2 diabetes but the level of proof remains low. Nutritional deficiencies
and chronic diarrhea are reported in both interventions. It seems that the OLGB would cause
more malabsorption and undernutrition but the OLGB would lead to less early operative
complications because it has only one gastro-jejunal anastomosis compared to RYGB which has
two.
The success of the RYGB for the remission of diabetes, is partly associated with a change in
secretion's profile of intestinal hormones participating in the glucose homeostasis,
especially the GLP-1. There is no studies published reporting the level of secretion (fasting
or postprandial) of gastrointestinal hormones after OLGB. It is important to understand how
this surgery produces its effects, especially on diabetes.
MINIBHO main hypothesis is that the secretion's profile of entero-insular hormones, like
GLP-1, are exacerbated after OLGB just like in RYGB, that would explain the same level of
improvement of T2 diabetes after both surgery.
Kinetic study of entero-insular secretion will be assessed by some blood dosages of
entero-insular hormones (GLP-1, GLP-2, Gastric inhibitory polypeptide (GIP), glicentine,
Insulin, peptide C, Glucagon and glucose) in 30 patients (15 OLGB and 15 RYGB). These dosages
will be made at different times after a meal test (during fasting, 15 minutes, 30 minutes, 60
minutes, 90 minutes and 120 minutes after the meal) to search a significant difference in the
profile of secretion between the OLGB and RYGB patients.
Investigators also hypothesize that the editing method of the OLGB leads to a decrease in the
food absorption profile compared to RYGB. To explore this hypothesis, citrulline and
apolipoprotein B48 (ApoB48) levels will be measured, which reflect enterocyte function of the
patients, and will be compared between patients operated with RYGB vs OLGB. Functional
enterocyte mass will be correlated to the absorptive function of the gut which will be
evaluated by the examination of the 24h feces.
The main objective is to determine whether the secretion profiles of entero-insular hormone
during a meal are different or not in patients operated with OLGB compared to RYGB. The
secondary objectives are to evaluate in these patients the absorptive function and the
functional enterocyte mass.
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