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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≥ 35 kg/m2

All patient with type 2 diabetes

Patients who were candidates for obesity surgery in accordance with French recommendation

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Roux-en-Y gastric bypass

    Procedure/Surgery

    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 gastric bypass

    Procedure/Surgery

    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

Treatment groups

396 Participants
are divided into 2 treatment groups
Group A: Standard Roux-en-YSham comparator 1 intervention
Group B: Long alimentary limb Roux-en-YActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of type 2 diabetes remission

HbA1c \< 6.5% AND fasting blood glucose \< 7.0 mmol/L in absence of antidiabetic drug

Time frame
at 12 months after surgery

Secondary outcomes

1

Absolute weight loss (aWL in kg)

Time frame
at 1, 3, 6 and 12 months after surgery
2

Excess Weight Loss percentage (EWL%)

Time frame
at 1, 3, 6 and 12 months after surgery
3

Excess BMI Loss percentage (EBL%)

Time frame
at 1, 3, 6 and 12 months after surgery
4

Medical and surgical complication rates

Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia)

Time frame
During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Ministry of Health, France

Collaborator