<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03821636</url>
  </required_header>
  <id_info>
    <org_study_id>2017_02</org_study_id>
    <secondary_id>2017-A01761-52</secondary_id>
    <secondary_id>PHRCI-16-090</secondary_id>
    <nct_id>NCT03821636</nct_id>
  </id_info>
  <brief_title>Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.</brief_title>
  <acronym>PRECI-Surg</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with type 2 diabetes, Roux-en-Y gastric bypass (RYGB), which excludes a portion&#xD;
      of the stomach and the proximal intestine from the alimentary circuit, improves glucose&#xD;
      metabolism more rapidly and more extensively than is expected from weight loss. The&#xD;
      mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have&#xD;
      not yet been clarified. A recent study unveil that intestinal uptake of ingested glucose is&#xD;
      diminished by RYGB and restricted to the common limb, where food meets bile and other&#xD;
      digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion.&#xD;
      the hypothesize that reducing the length of the common limb, which is rarely measured and&#xD;
      highly variable in clinical practice, may significantly affect the metabolic outcome of&#xD;
      gastrointestinal surgical procedures. The aim of the present study is to compare the impact&#xD;
      of two variants of Roux-en-Y gastric bypass with a short common limb, the long alimentary&#xD;
      limb or the long biliary limb Roux-en-Y gastric bypass, on type 2 diabetes remission in&#xD;
      severely obese patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 16, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of type 2 diabetes remission</measure>
    <time_frame>at 12 months after surgery</time_frame>
    <description>HbA1c &lt; 6.5% AND fasting blood glucose &lt; 7.0 mmol/L in absence of antidiabetic drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute weight loss (aWL in kg)</measure>
    <time_frame>at 1, 3, 6 and 12 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excess Weight Loss percentage (EWL%)</measure>
    <time_frame>at 1, 3, 6 and 12 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excess BMI Loss percentage (EBL%)</measure>
    <time_frame>at 1, 3, 6 and 12 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical and surgical complication rates</measure>
    <time_frame>During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]</time_frame>
    <description>Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type and severity of early and late complications for each procedure</measure>
    <time_frame>During the month following surgery (for early complications) and from one month to 12 months postoperatively (for late complications)]</time_frame>
    <description>Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's quality of life score according to the Impact of Weight on Quality of Life (IWQOL) questionnaire</measure>
    <time_frame>Before surgery and at 12 after surgery</time_frame>
    <description>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.&#xD;
The final 20-item IWQOL includes two primary domains: Physical (7 items) and Psychosocial (13 items)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's quality of life score according to the Gastrointestinal Quality of Life Index (GIQLI) questionnaire adapted to bariatric surgery.</measure>
    <time_frame>Before surgery and at 12 after surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucose homeostasis</measure>
    <time_frame>Before surgery and at 3, 6 and 12 months after surgery</time_frame>
    <description>glucose (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>Before surgery and at 3, 6 and 12 months after surgery</time_frame>
    <description>Changes in HbA1c(%) were assessed before and after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting glycemia</measure>
    <time_frame>Before surgery and at 3, 6 and 12 months after surgery</time_frame>
    <description>Changes in fasting blood glucose levels (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in fasting insulinemia</measure>
    <time_frame>Before surgery and at 3, 6 and 12 months after surgery</time_frame>
    <description>Changes in fasting insulinemia in microunits/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in fasting c-peptide</measure>
    <time_frame>Before surgery and at 3, 6 and 12 months after surgery</time_frame>
    <description>Changes in C-peptide(ng/ml) were assessed before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of antidiabetic treatments</measure>
    <time_frame>Before surgery and at 3, 6 and 12 months after surgery</time_frame>
    <description>Metabolic profile of glucose homeostasis assessment according to antidiabetic treatments, HbA1c level, fasting glycemia, fasting insulinemia fasting c-peptide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood lipids profile</measure>
    <time_frame>Before surgery and at 1, 3, 6 and 12 months after surgery</time_frame>
    <description>Changes in blood lipids profile (LDL, HDL and triglyceride concentrations) according to anitilipidemic treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in vitamins status assessment</measure>
    <time_frame>Before surgery and at 1, 3, 6 and 12 months after surgery</time_frame>
    <description>vitamines profil (vitamin B1, B9, B12, and D concentration) before and 12 and 24 months after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in prealbumin levels</measure>
    <time_frame>Before surgery and at 1, 3, 6 and 12 months after surgery</time_frame>
    <description>Lower levels of prealbumin are associated with malnutrition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">396</enrollment>
  <condition>Diabetes Mellitus Type 2 in Obese</condition>
  <arm_group>
    <arm_group_label>Standard Roux-en-Y</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Long alimentary limb Roux-en-Y</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Roux-en-Y gastric bypass</intervention_name>
    <description>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).</description>
    <arm_group_label>Standard Roux-en-Y</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Long alimentary limb Roux-en-Y gastric bypass</intervention_name>
    <description>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</description>
    <arm_group_label>Long alimentary limb Roux-en-Y</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 35 kg/m2&#xD;
&#xD;
          -  All patient with type 2 diabetes&#xD;
&#xD;
          -  Patients who were candidates for obesity surgery in accordance with French&#xD;
             recommendation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive or mental disorders&#xD;
&#xD;
          -  patient who have already undergone obesity surgery&#xD;
&#xD;
          -  Severe and non-stabilised eating disorders&#xD;
&#xD;
          -  The likely inability of the patient to participate in lifelong medical follow-up&#xD;
&#xD;
          -  Alcohol or psychoactive substances dependence&#xD;
&#xD;
          -  The absence of identified prior medical management of obesity&#xD;
&#xD;
          -  Diseases that are life-threatening in the short and medium term;&#xD;
&#xD;
          -  Contraindications to general anaesthesia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grégory BAUD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Grégory BAUD, MD</last_name>
    <phone>3.20.44.42.73</phone>
    <phone_ext>+33</phone_ext>
    <email>gregory.baud@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Boulogne-Sur-Me</name>
      <address>
        <city>Boulogne Sur Mer</city>
        <zip>62321</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0321993333</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hop Claude Huriez Chu Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch de Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Diabetes Mellitus Type 2</keyword>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Roux-en-Y</keyword>
  <keyword>gastric bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821636
org study id: 2017_02
secondary id: 2017-A01761-52
secondary id: PHRCI-16-090
nct id: NCT03821636
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Rate of type 2 diabetes remission
time frame: at 12 months after surgery
description: HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
measure: Absolute weight loss (aWL in kg)
time frame: at 1, 3, 6 and 12 months after surgery
measure: Excess Weight Loss percentage (EWL%)
time frame: at 1, 3, 6 and 12 months after surgery
measure: Excess BMI Loss percentage (EBL%)
time frame: at 1, 3, 6 and 12 months after surgery
measure: 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)]
description: Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia)
measure: 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)]
description: Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification
measure: 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
description: 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)
measure: 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
description: 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.
measure: Change in glucose homeostasis
time frame: Before surgery and at 3, 6 and 12 months after surgery
description: glucose (mg/dl)
measure: Change in HbA1c
time frame: Before surgery and at 3, 6 and 12 months after surgery
description: Changes in HbA1c(%) were assessed before and after surgery
measure: Change in fasting glycemia
time frame: Before surgery and at 3, 6 and 12 months after surgery
description: Changes in fasting blood glucose levels (mmol/L)
measure: changes in fasting insulinemia
time frame: Before surgery and at 3, 6 and 12 months after surgery
description: Changes in fasting insulinemia in microunits/mL
measure: change in fasting c-peptide
time frame: Before surgery and at 3, 6 and 12 months after surgery
description: Changes in C-peptide(ng/ml) were assessed before and after the intervention.
measure: Number of antidiabetic treatments
time frame: Before surgery and at 3, 6 and 12 months after surgery
description: Metabolic profile of glucose homeostasis assessment according to antidiabetic treatments, HbA1c level, fasting glycemia, fasting insulinemia fasting c-peptide
measure: Changes in blood lipids profile
time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
description: Changes in blood lipids profile (LDL, HDL and triglyceride concentrations) according to anitilipidemic treatments
measure: change in vitamins status assessment
time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
description: vitamines profil (vitamin B1, B9, B12, and D concentration) before and 12 and 24 months after surgery
measure: change in prealbumin levels
time frame: Before surgery and at 1, 3, 6 and 12 months after surgery
description: Lower levels of prealbumin are associated with malnutrition.
arm group label: Standard Roux-en-Y
arm group type: Sham Comparator
arm group label: Long alimentary limb Roux-en-Y
arm group type: Active Comparator
intervention type: Procedure
intervention name: Standard Roux-en-Y gastric bypass
description: 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).
arm group label: Standard Roux-en-Y
intervention type: Procedure
intervention name: Long alimentary limb Roux-en-Y gastric bypass
description: 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
arm group label: Long alimentary limb Roux-en-Y
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Grégory BAUD, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Grégory BAUD, MD
phone: 3.20.44.42.73
phone ext: +33
email: gregory.baud@chru-lille.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2