<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/NCT04432025</url>
  </required_header>
  <id_info>
    <org_study_id>20HH5928</org_study_id>
    <nct_id>NCT04432025</nct_id>
  </id_info>
  <brief_title>Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus</brief_title>
  <acronym>BY-PLUS</acronym>
  <official_title>Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</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>
      The aim of this study is to investigate the continued usage of standard diabetes medications&#xD;
      in the post operative period following bariatric surgery to determine whether this approach&#xD;
      may improve long term diabetes control. At present, the standard of treatment in patients&#xD;
      with type 2 diabetes is that all medication is stopped in the immediate postoperative period&#xD;
      and only re-started if symptoms of diabetes re-emerge. Although a large proportion of&#xD;
      patients with diabetes will initially go in to remission, 80% experience relapse within five&#xD;
      years. This study is needed to determine whether continuing medications is not only safe but&#xD;
      will improve long term outcomes for patients with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">August 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2027</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>
    <intervention_model_description>Patients will be randomly allocated to the control arm (bariatric surgery- either RYGB or SG) or intervention (bariatric surgery- either RYGB or SG + goal directed medical therapy for t2DM)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients in each group reaching the composite end point</measure>
    <time_frame>5 years</time_frame>
    <description>BP&lt;130/80, HbA1c&lt;6.5%, LDL&lt;2.6mmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients reaching end point for glycemic control</measure>
    <time_frame>1 year</time_frame>
    <description>HbA1c&lt;6.5%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>5 years</time_frame>
    <description>Change in body weight from baseline (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BMI</measure>
    <time_frame>5 years</time_frame>
    <description>Change in BMI from baseline (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>5 years</time_frame>
    <description>Change in waist circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid control</measure>
    <time_frame>5 years</time_frame>
    <description>Proportion of patients achieving good lipid control (LDL&lt;2.6mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycaemic control</measure>
    <time_frame>5 years</time_frame>
    <description>Change in long term glycaemic control(HbA1c)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>5 years</time_frame>
    <description>Proportion of patients achieving BP&lt;130/80mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in liver function</measure>
    <time_frame>5 years</time_frame>
    <description>Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in renal function</measure>
    <time_frame>5 years</time_frame>
    <description>Proportion of patients with normal renal function (plasma Cr, eGFR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory markers</measure>
    <time_frame>5 years</time_frame>
    <description>Reduction in CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urine albumin: creatinine ratio</measure>
    <time_frame>5 years</time_frame>
    <description>Proportion of patients in each group with a uACR&lt;30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>5 years</time_frame>
    <description>Quality of life change as determined by SF-36 and MPH-H</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Obesity</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy. Long term diabetes care will be under the supervision of their primary care provider/general practitioner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy and will have ongoing goal directed medical treatment for their T2DM, titrated to specific end points for BP, HbA1c and lipids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery + goal directed medical therapy</intervention_name>
    <description>Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery</intervention_name>
    <description>Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  eligible for bariatric surgery according to NICE guidelines (GC 189)&#xD;
&#xD;
          -  Type 2 diabetes mellitus&#xD;
&#xD;
          -  BMI &gt;30kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent hospitalisation in the past 30 days&#xD;
&#xD;
          -  Recurrent hypoglycaemic episodes&#xD;
&#xD;
          -  Recurrent hypotensive episodes&#xD;
&#xD;
          -  Contraindications to bariatric surgery&#xD;
&#xD;
          -  Previous bariatric surgery&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alexander Miras, MRCP</last_name>
    <phone>: +44 (0)20 8383 3242</phone>
    <email>a.miras@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>University College Dublin</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carel le Roux, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>type 2 diabetes</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The authors shall make data available to the scientific community with as few restrictions as feasible, ensuring anonymisation, while retaining exclusive use until the publication of major outputs.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>6 months</ipd_time_frame>
    <ipd_access_criteria>Free access</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04432025
org study id: 20HH5928
nct id: NCT04432025
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the continued usage of standard diabetes medications
      in the post operative period following bariatric surgery to determine whether this approach
      may improve long term diabetes control. At present, the standard of treatment in patients
      with type 2 diabetes is that all medication is stopped in the immediate postoperative period
      and only re-started if symptoms of diabetes re-emerge. Although a large proportion of
      patients with diabetes will initially go in to remission, 80% experience relapse within five
      years. This study is needed to determine whether continuing medications is not only safe but
      will improve long term outcomes for patients with diabetes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly allocated to the control arm (bariatric surgery- either RYGB or SG) or intervention (bariatric surgery- either RYGB or SG + goal directed medical therapy for t2DM)
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients in each group reaching the composite end point
time frame: 5 years
description: BP<130/80, HbA1c<6.5%, LDL<2.6mmol/L
measure: Proportion of patients reaching end point for glycemic control
time frame: 1 year
description: HbA1c<6.5%
measure: Change in body weight
time frame: 5 years
description: Change in body weight from baseline (kg)
measure: Change in BMI
time frame: 5 years
description: Change in BMI from baseline (kg/m2)
measure: Change in waist circumference
time frame: 5 years
description: Change in waist circumference (cm)
measure: Change in lipid control
time frame: 5 years
description: Proportion of patients achieving good lipid control (LDL<2.6mmol/L)
measure: Change in glycaemic control
time frame: 5 years
description: Change in long term glycaemic control(HbA1c)
measure: Change in blood pressure
time frame: 5 years
description: Proportion of patients achieving BP<130/80mmHg
measure: Change in liver function
time frame: 5 years
description: Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST)
measure: Change in renal function
time frame: 5 years
description: Proportion of patients with normal renal function (plasma Cr, eGFR)
measure: Change in inflammatory markers
time frame: 5 years
description: Reduction in CRP
measure: Change in urine albumin: creatinine ratio
time frame: 5 years
description: Proportion of patients in each group with a uACR<30
measure: Change in quality of life
time frame: 5 years
description: Quality of life change as determined by SF-36 and MPH-H
arm group label: Control
arm group type: Active Comparator
description: Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy. Long term diabetes care will be under the supervision of their primary care provider/general practitioner
arm group label: Intervention
arm group type: Experimental
description: Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy and will have ongoing goal directed medical treatment for their T2DM, titrated to specific end points for BP, HbA1c and lipids.
intervention type: Procedure
intervention name: Bariatric surgery + goal directed medical therapy
description: Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids
arm group label: Intervention
intervention type: Procedure
intervention name: Bariatric surgery
description: Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Miras, MRCP
phone: : +44 (0)20 8383 3242
email: a.miras@nhs.net
facility: 
status: Recruiting
contact: 
country: Ireland
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: The authors shall make data available to the scientific community with as few restrictions as feasible, ensuring anonymisation, while retaining exclusive use until the publication of major outputs.
ipd info type: Study Protocol
ipd time frame: 6 months
ipd access criteria: Free access