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MINI Bypass Versus Roux-en-Y Bypass: Differences in HOrmonal Secretions at 2 Years of Surgery (MINIBHO)

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ClinicalTrials.gov Identifier: NCT03482895
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Société Francophone Nutrition Clinique et Métabolisme
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Bariatric Surgery Biological: Blood sampling Biological: Feces sampling

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.


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Estimated Study Start Date : April 3, 2018
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient: Blood sampling & Feces sampling

Blood samplings at different times after a meal test: 0, 15, 30, 60, 90 and 120 minutes.

Feces sampling: collection during 24 hours

Biological: Blood sampling
Quantitative analysis of enterohormones, citrulline and ApoB48

Biological: Feces sampling
Intestinal absorption assessment




Primary Outcome Measures :
  1. Kinetic of GLP-1 secretion [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of GLP-1


Secondary Outcome Measures :
  1. Plasmatic dosage of citrulline [ Time Frame: Baseline ]
    Plasmatic concentration of Citrulline versus enterocyte mass function

  2. Plasmatic dosage of Apolipoprotein B48 [ Time Frame: Baseline ]
    Plasmatic concentration of Apolipoprotein B48 versus enterocyte mass function

  3. Lipidic Absorptive Coefficient [ Time Frame: 1 day ]
    Percentage between lipidic food intakes and lipidic excretion in feces

  4. Protein Absorptive Coefficient [ Time Frame: 1 day ]
    Percentage between protein food intakes and protein excretion in feces

  5. Glucidic Absorptive Coefficient [ Time Frame: 1 day ]
    Percentage between carbohydrate food intakes and carbohydrate excretion in feces

  6. kinetic of GLP-2 secretion [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of GLP-2

  7. Kinetic of GIP secretion [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of GIP

  8. Kinetic of Peptide C secretion [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of Peptide C

  9. Kinetic of Insulin secretion [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of Insulin

  10. Kinetic of Glucagon secretion [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of Glucagon

  11. Kinetic of Glicentin secretion [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of Glicentin

  12. Kinetic of Glycemia [ Time Frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test ]
    Area under the plasma concentration versus time curve of glucose


Biospecimen Retention:   Samples Without DNA
Blood sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient recruited 2 years (+/- 6 months) after Omega-loop Gastric Bypass or Roux-en-Y Gastric Bypass
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482895


Contacts
Contact: Claire Carette +33156095521 claire.carette@aphp.fr

Locations
France
AP-HP - Hôpital Européen Georges-Pompidou Recruiting
Paris, Île-de-France, France, 75015
Contact: Claire Carette, MD       claire.carette@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société Francophone Nutrition Clinique et Métabolisme
Investigators
Principal Investigator: Claire Carette, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03482895     History of Changes
Other Study ID Numbers: K171007J
2017-A02816-47 ( Other Identifier: France: ANSM )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Gastric Bypass
Intestinal Absorption
Gastrointestinal Hormones
Enteroendocrine Cells