Diabetes Mellitus Type 2 in ObesePRECI-SurgNCT03821636
Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.
A study testing Standard Roux-en-Y gastric bypass and Long alimentary limb Roux-en-Y gastric bypass in people with Diabetes Mellitus Type 2 in Obese, run by University Hospital, Lille at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese
- What is being tested?
- Standard Roux-en-Y gastric bypass and Long alimentary limb Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 4 sitesFrance
- Study dates
- 16 Jun 2019to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 35 kg/m2
- All patient with type 2 diabetes
- Patients who were candidates for obesity surgery in accordance with French recommendation
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Chu Amiens Picardie
Amiens
- Recruiting
Ch Boulogne-Sur-Me
Boulogne-sur-Mer, 62321
0321993333
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
- Recruiting
Ch de Valenciennes
Valenciennes
About this study
Official title: Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients. A Prospective, Multicentric, Randomized, Controlled 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.
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Being tested
- Standard Roux-en-Y gastric bypass, Long alimentary limb Roux-en-Y gastric bypass
- Keywords
- Obesity, Diabetes Mellitus Type 2, Bariatric Surgery, Roux-en-Y, gastric bypass
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Roux-en-Y gastric bypassProcedure or 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 bypassProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Standard Roux-en-Y | Sham comparator | Not described Receives: Procedure: Standard Roux-en-Y gastric bypass |
| Long alimentary limb Roux-en-Y | Active comparator | Not described Receives: Procedure: Long alimentary limb Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of type 2 diabetes remission
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
Measured: at 12 months after surgery
Secondary outcomes (16)
Absolute weight loss (aWL in kg)
Measured: at 1, 3, 6 and 12 months after surgery
Excess Weight Loss percentage (EWL%)
Measured: at 1, 3, 6 and 12 months after surgery
Excess BMI Loss percentage (EBL%)
Measured: at 1, 3, 6 and 12 months after surgery
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)
Measured: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
Type and severity of early and late complications for each procedure
Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification
Measured: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire
The IWQOL questionnaire to be specifically assess the effects of obesity on health-related quality of life. The five identified scales are Physical Function, Self-Esteem, Sexual Life, Public Distress, and Work.
The final 20-item IWQOL includes two primary domains: Physical (7 items) and Psychosocial (13 items)
Measured: Before surgery and at 12 after surgery
Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery.
GIQLI (gastrointestinal quality of life index) questionnaire. 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.
Measured: Before surgery and at 12 after surgery
Change in glucose homeostasis
glucose (mg/dl)
Measured: Before surgery and at 3, 6 and 12 months after surgery
Change in HbA1c
Changes in HbA1c(%) were assessed before and after surgery
Measured: Before surgery and at 3, 6 and 12 months after surgery
Change in fasting glycemia
Changes in fasting blood glucose levels (mmol/L)
Measured: Before surgery and at 3, 6 and 12 months after surgery
changes in fasting insulinemia
Changes in fasting insulinemia in microunits/mL
Measured: Before surgery and at 3, 6 and 12 months after surgery
change in fasting c-peptide
Changes in C-peptide(ng/ml) were assessed before and after the intervention.
Measured: Before surgery and at 3, 6 and 12 months after surgery
Number of antidiabetic treatments
Metabolic profile of glucose homeostasis assessment according to antidiabetic treatments, HbA1c level, fasting glycemia, fasting insulinemia fasting c-peptide
Measured: Before surgery and at 3, 6 and 12 months after surgery
Changes in blood lipids profile
Changes in blood lipids profile (LDL, HDL and triglyceride concentrations) according to anitilipidemic treatments
Measured: Before surgery and at 1, 3, 6 and 12 months after surgery
change in vitamins status assessment
vitamines profil (vitamin B1, B9, B12, and D concentration) before and 12 and 24 months after surgery
Measured: Before surgery and at 1, 3, 6 and 12 months after surgery
change in prealbumin levels
Lower levels of prealbumin are associated with malnutrition.
Measured: Before surgery and at 1, 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start16 Jun 2019
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Grégory BAUD, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821636
- Sponsor's protocol ID
- 2017_02
- Other IDs
- 2017-A01761-52, PHRCI-16-090
- Acronym
- PRECI-Surg
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients. A Prospective, Multicentric, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT03821636
- Acronym / sponsor ID
- PRECI-Surg / 2017_02
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Keywords
- Obesity, Diabetes Mellitus Type 2, Bariatric Surgery, Roux-en-Y, gastric bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Roux-en-Y | Sham comparator | Procedure: Standard Roux-en-Y gastric bypass |
| Long alimentary limb Roux-en-Y | Active comparator | Procedure: Long alimentary limb Roux-en-Y gastric bypass |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI ≥ 35 kg/m2
- All patient with type 2 diabetes
- Patients who were candidates for obesity surgery in accordance with French recommendation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Roux-en-Y gastric bypassStandard 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). | Procedure or surgery | Standard Roux-en-Y |
| Long alimentary limb Roux-en-Y gastric bypassLong 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 | Procedure or surgery | Long alimentary limb Roux-en-Y |
Primary outcome
Rate of type 2 diabetes remission
Time frame: at 12 months after surgery
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
16 secondary outcomes
Absolute weight loss (aWL in kg)
Time frame: at 1, 3, 6 and 12 months after surgery
Excess Weight Loss percentage (EWL%)
Time frame: at 1, 3, 6 and 12 months after surgery
Excess BMI Loss percentage (EBL%)
Time frame: at 1, 3, 6 and 12 months after surgery
Medical and surgical complication rates
Time frame: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
Type and severity of early and late complications for each procedure
Time frame: During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]
Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire
Time frame: Before surgery and at 12 after surgery
Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery.
Time frame: Before surgery and at 12 after surgery
Change in glucose homeostasis
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Change in HbA1c
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Change in fasting glycemia
Time frame: Before surgery and at 3, 6 and 12 months after surgery
changes in fasting insulinemia
Time frame: Before surgery and at 3, 6 and 12 months after surgery
change in fasting c-peptide
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Number of antidiabetic treatments
Time frame: Before surgery and at 3, 6 and 12 months after surgery
Changes in blood lipids profile
Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
change in vitamins status assessment
Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
change in prealbumin levels
Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grégory BAUD, MD principal investigator
University Hospital, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Roux-en-Y gastric bypass and Long alimentary limb Roux-en-Y gastric bypass in people with Diabetes Mellitus Type 2 in Obese, run by University Hospital, Lille at 4 sites 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 8 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grégory BAUD, MD (3.20.44.42.73 ext. +33, gregory.baud@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of type 2 diabetes remission (time frame: at 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.