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Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.

NCT ID: NCT03821636

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-16

Study Completion Date

2026-06-30

Brief Summary

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In patients with type 2 diabetes, Roux-en-Y gastric bypass (RYGB), which excludes a portion of the stomach and the proximal intestine from the alimentary circuit, improves glucose metabolism more rapidly and more extensively than is expected from weight loss. The mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have not yet been clarified. A recent study unveil that intestinal uptake of ingested glucose is diminished by RYGB and restricted to the common limb, where food meets bile and other digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion. the hypothesize that reducing the length of the common limb, which is rarely measured and highly variable in clinical practice, may significantly affect the metabolic outcome of gastrointestinal surgical procedures. The aim of the present study is to compare the impact of two variants of Roux-en-Y gastric bypass with a short common limb, the long alimentary limb or the long biliary limb Roux-en-Y gastric bypass, on type 2 diabetes remission in severely obese patients.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2 in Obese

Keywords

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Obesity Diabetes Mellitus Type 2 Bariatric Surgery Roux-en-Y gastric bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Roux-en-Y

Group Type SHAM_COMPARATOR

Standard Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Standard Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 25 % of total length of the intestine (150 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 65 % of total length of the intestine (400 cm).

Long alimentary limb Roux-en-Y

Group Type ACTIVE_COMPARATOR

Long alimentary limb Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Long alimentary limb Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 45 % of total length of the intestine (280 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 45 % of total length of the intestine (280 cm

Interventions

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Standard Roux-en-Y gastric bypass

Standard Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 25 % of total length of the intestine (150 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 65 % of total length of the intestine (400 cm).

Intervention Type PROCEDURE

Long alimentary limb Roux-en-Y gastric bypass

Long alimentary limb Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 45 % of total length of the intestine (280 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 45 % of total length of the intestine (280 cm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI ≥ 35 kg/m2
* All patient with type 2 diabetes
* Patients who were candidates for obesity surgery in accordance with French recommendation

Exclusion Criteria

* Severe cognitive or mental disorders
* patient who have already undergone obesity surgery
* Severe and non-stabilised eating disorders
* The likely inability of the patient to participate in lifelong medical follow-up
* Alcohol or psychoactive substances dependence
* The absence of identified prior medical management of obesity
* Diseases that are life-threatening in the short and medium term;
* Contraindications to general anaesthesia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grégory BAUD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Chu Amiens Picardie

Amiens, , France

Site Status RECRUITING

Ch Boulogne-Sur-Me

Boulogne-sur-Mer, , France

Site Status RECRUITING

Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Ch de Valenciennes

Valenciennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Grégory BAUD, MD

Role: CONTACT

Phone: 3.20.44.42.73

Email: [email protected]

Facility Contacts

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Role: primary

Role: primary

Other Identifiers

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2017-A01761-52

Identifier Type: OTHER

Identifier Source: secondary_id

PHRCI-16-090

Identifier Type: OTHER

Identifier Source: secondary_id

2017_02

Identifier Type: -

Identifier Source: org_study_id