Clinical trial NCT03482895: MINI Bypass Versus Roux-en-Y Bypass: Differences in HOrmonal Secretions at 2 Years of Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Keywords: Gastric Bypass
Intestinal Absorption
Gastrointestinal Hormones
Enteroendocrine Cells
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Société Francophone Nutrition Clinique et Métabolisme
First posted: 2018-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient recruited 2 years (+/- 6 months) after Omega-loop Gastric Bypass or Roux-en-Y Gastric Bypass

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Roux en Y gastric bypass or omega loop gastric bypass at two years of the surgery (6 months more or less)
* 18 years minimum
* weight \> 40kg

Exclusion Criteria:

* Type 1 diabetes diagnosed with the positivity of anti Glutamate Acid Decarboxylase (GAD) or anti Ia2
* Treatment with Insulin, Glucagon Like Peptide 1 (GLP1) or anti-DiPeptidyl Peptidase-4 (DPP4) during the study
* Unbalanced type 2 diabetes : HbA1c \> 8%
* Anemia with hemoglobin \< 7g/dl
* Gut inflammatory disease ; infectious disease, cancer, iatrogenic disease, auto-immune disease
* Pregnant or breastfeeding women
* allergy to Carmin (E120)
* participation to another clinical trial
* patient under legal protection

Primary outcomes:
measure: Kinetic of GLP-1 secretion
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
Secondary outcomes:
measure: Plasmatic dosage of citrulline
timeFrame: Baseline
measure: Plasmatic dosage of Apolipoprotein B48
timeFrame: Baseline
measure: Lipidic Absorptive Coefficient
timeFrame: 1 day
measure: Protein Absorptive Coefficient
timeFrame: 1 day
measure: Glucidic Absorptive Coefficient
timeFrame: 1 day
measure: kinetic of GLP-2 secretion
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
measure: Kinetic of GIP secretion
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
measure: Kinetic of Peptide C secretion
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
measure: Kinetic of Insulin secretion
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
measure: Kinetic of Glucagon secretion
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
measure: Kinetic of Glicentin secretion
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
measure: Kinetic of Glycemia
timeFrame: 0, 15, 30, 60, 90 and 120 minutes after a meal test
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hôpital Européen Georges-Pompidou
state: Île-de-France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claire Carette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Bandt D, Rives-Lange C, Frigout Y, Bergerot D, Blanchard A, Le Gall M, Lacorte JM, Chevallier JM, Czernichow S, Poghosyan T, Carette C, Le Beyec J. Similar Gut Hormone Secretions Two Years After One Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass: a Pilot Study. Obes Surg. 2022 Mar;32(3):757-762. doi: 10.1007/s11695-021-05837-5. Epub 2022 Jan 7.