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Bariatric SurgeryMINIBHONCT03482895

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

An observational study of Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bariatric Surgery
What is being tested?
Blood sampling and Feces sampling
How many people
30 participants
Where
1 siteFrance
Study dates
4 Apr 2018to 14 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • allergy to Carmin (E120)
  • participation to another clinical trial
  • patient under legal protection

Trial locations and contacts

1 site in 1 country.

France1 site

  • AP-HP - Hôpital Européen Georges-Pompidou

    Paris, Île-de-France Region, 75015

Other trials in France

About this study

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.

Read the 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.

Being tested
Blood sampling, Feces sampling
Keywords
Gastric Bypass, Intestinal Absorption, Gastrointestinal Hormones, Enteroendocrine Cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingBiological

    Quantitative analysis of enterohormones, citrulline and ApoB48

  • Feces samplingBiological

    Intestinal absorption assessment

Study groups in NCT03482895
Study groupRoleWhat they receive
Patient: Blood sampling & Feces samplingBlood samplings at different times after a meal test: 0, 15, 30, 60, 90 and 120 minutes. Feces sampling: collection during 24 hours
Receives: Biological: Blood sampling; Biological: Feces sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinetic of GLP-1 secretion

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

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

Secondary outcomes (12)

  1. Plasmatic dosage of citrulline

    Plasmatic concentration of Citrulline versus enterocyte mass function

    Measured: Baseline

  2. Plasmatic dosage of Apolipoprotein B48

    Plasmatic concentration of Apolipoprotein B48 versus enterocyte mass function

    Measured: Baseline

  3. Lipidic Absorptive Coefficient

    Percentage between lipidic food intakes and lipidic excretion in feces

    Measured: 1 day

  4. Protein Absorptive Coefficient

    Percentage between protein food intakes and protein excretion in feces

    Measured: 1 day

  5. Glucidic Absorptive Coefficient

    Percentage between carbohydrate food intakes and carbohydrate excretion in feces

    Measured: 1 day

  6. kinetic of GLP-2 secretion

    Area under the plasma concentration versus time curve of GLP-2

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

  7. Kinetic of GIP secretion

    Area under the plasma concentration versus time curve of GIP

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

  8. Kinetic of Peptide C secretion

    Area under the plasma concentration versus time curve of Peptide C

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

  9. Kinetic of Insulin secretion

    Area under the plasma concentration versus time curve of Insulin

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

  10. Kinetic of Glucagon secretion

    Area under the plasma concentration versus time curve of Glucagon

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

  11. Kinetic of Glicentin secretion

    Area under the plasma concentration versus time curve of Glicentin

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

  12. Kinetic of Glycemia

    Area under the plasma concentration versus time curve of glucose

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start4 Apr 2018
  3. Primary completion14 May 2019
  4. Study completion14 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03482895
Sponsor's protocol ID
K171007J
Other IDs
2017-A02816-47
Acronym
MINIBHO
Status last verified
Sep 2019
First submitted
23 Mar 2018
Last updated
23 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34993850

Questions about this trial

What is this clinical trial studying?

An observational study of Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinetic of GLP-1 secretion (time frame: 0, 15, 30, 60, 90 and 120 minutes after a meal test). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03482895, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.

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