NCT03482895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

March 23, 2018

Last Update Submit

September 20, 2019

Conditions

Bariatric Surgery

Keywords

Gastric BypassIntestinal AbsorptionGastrointestinal HormonesEnteroendocrine Cells

Outcome Measures

Primary Outcomes (1)

  • Kinetic of GLP-1 secretion

    Area under the plasma concentration versus time curve of GLP-1

    0, 15, 30, 60, 90 and 120 minutes after a meal test

Secondary Outcomes (12)

  • Plasmatic dosage of citrulline

    Baseline

  • Plasmatic dosage of Apolipoprotein B48

    Baseline

  • Lipidic Absorptive Coefficient

    1 day

  • Protein Absorptive Coefficient

    1 day

  • Glucidic Absorptive Coefficient

    1 day

  • +7 more secondary outcomes

Study Arms (1)

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 samplingBiological: Feces sampling

Interventions

Blood samplingBIOLOGICAL

Quantitative analysis of enterohormones, citrulline and ApoB48

Patient: Blood sampling & Feces sampling
Feces samplingBIOLOGICAL

Intestinal absorption assessment

Patient: Blood sampling & Feces sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient recruited 2 years (+/- 6 months) after Omega-loop Gastric Bypass or Roux-en-Y Gastric Bypass

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP - Hôpital Européen Georges-Pompidou

Paris, Île-de-France Region, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 34993850DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Claire Carette, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 29, 2018

Study Start

April 4, 2018

Primary Completion

May 14, 2019

Study Completion

May 14, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)