<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/NCT04442698</url>
  </required_header>
  <id_info>
    <org_study_id>KularH</org_study_id>
    <nct_id>NCT04442698</nct_id>
  </id_info>
  <brief_title>Tailored Bilio-Pancreatic Limb and HbA1c 10 Years Post Mini-Gastric Bypass</brief_title>
  <acronym>BPLLvHbA1c</acronym>
  <official_title>Tailored Bilio-Pancreatic Limb Length and Hemoglobin A1c Levels 10 Years Following Mini-Gastric Bypass Original Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kular Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kular Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare&#xD;
      costs in addition to the costs in human lives, suffering and disability. Treatment that&#xD;
      lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general&#xD;
      surgery and bariatric procedures may improve or reverse diabetes. In several studies the&#xD;
      Billroth II reconstruction following gastrectomy was the most effective surgical technique in&#xD;
      improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the&#xD;
      Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB)&#xD;
      to investigate the association of a &quot;Tailored&quot; Bilio-pancreatic Limb Length (BPLL) with the&#xD;
      HbA1c changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies&#xD;
      also make clear the devastating impact of diabetes on both healthcare costs in addition to&#xD;
      the costs in human lives, suffering and disability. It is also clear that treatment that&#xD;
      lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease,&#xD;
      saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in&#xD;
      less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both&#xD;
      general surgery and bariatric procedures may improve or reverse diabetes. In several studies&#xD;
      the Billroth II reconstruction following gastrectomy is the most effective surgical technique&#xD;
      in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of&#xD;
      the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass&#xD;
      (OAGB) to investigate the association of a &quot;Tailored&quot; Bilio-pancreatic Limb Length (BPLL)&#xD;
      with the HbA1c changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2008</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin A1c Levels (HbA1c)</measure>
    <time_frame>10 years</time_frame>
    <description>HbA1c Levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Delta Hemoglobin A1c Levels (HbA1c)</measure>
    <time_frame>10 years</time_frame>
    <description>Delta HbA1c from Before to After MGB-OT surgery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>Diabetes</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Diabetic MGB post op patients</arm_group_label>
    <description>Diabetic MGB post op patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mini-Gastric Bypass Original Technique</intervention_name>
    <description>Follow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique</description>
    <arm_group_label>Diabetic MGB post op patients</arm_group_label>
    <other_name>One Anastomosis Bypass</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having undergone Mini-Gastric Bypass -Original Technique post operative patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mini-Gastric Bypass -Original Technique post operative patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kular Hospital</name>
      <address>
        <city>Khanna</city>
        <state>Punjab</state>
        <zip>141412</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kular Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Robert Rutledge</investigator_full_name>
    <investigator_title>Research Director</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04442698
org study id: KularH
nct id: NCT04442698
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare
      costs in addition to the costs in human lives, suffering and disability. Treatment that
      lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general
      surgery and bariatric procedures may improve or reverse diabetes. In several studies the
      Billroth II reconstruction following gastrectomy was the most effective surgical technique in
      improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the
      Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB)
      to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the
      HbA1c changes.
There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies
      also make clear the devastating impact of diabetes on both healthcare costs in addition to
      the costs in human lives, suffering and disability. It is also clear that treatment that
      lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease,
      saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in
      less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both
      general surgery and bariatric procedures may improve or reverse diabetes. In several studies
      the Billroth II reconstruction following gastrectomy is the most effective surgical technique
      in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of
      the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass
      (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL)
      with the HbA1c changes.
observational model: Cohort
time perspective: Retrospective
measure: Hemoglobin A1c Levels (HbA1c)
time frame: 10 years
description: HbA1c Levels
measure: Delta Hemoglobin A1c Levels (HbA1c)
time frame: 10 years
description: Delta HbA1c from Before to After MGB-OT surgery
arm group label: Diabetic MGB post op patients
description: Diabetic MGB post op patients
intervention type: Procedure
intervention name: Mini-Gastric Bypass Original Technique
description: Follow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique
arm group label: Diabetic MGB post op patients
other name: One Anastomosis Bypass
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Kular Hospital
investigator full name: Dr. Robert Rutledge
investigator title: Research Director
sharing ipd: No