<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/NCT04414072</url>
  </required_header>
  <id_info>
    <org_study_id>367177</org_study_id>
    <nct_id>NCT04414072</nct_id>
  </id_info>
  <brief_title>Local GIT Hormones After Bariatric Maneuvers</brief_title>
  <official_title>Effect of Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Many of the beneficial metabolic effects of bariatric surgery have been&#xD;
      attributed to altered peptide hormone profiles, especially involving pancreatic and gut&#xD;
      peptides.&#xD;
&#xD;
      Objectives: assess the effects of bariatric procedures (sleeve gastrectomy, minigastric&#xD;
      bypass and sleeve gastrectomy with loop bipartition) on GIT hormones. Methods: Prospective&#xD;
      randomized study which was carried out in the department of General Surgery, Minia University&#xD;
      hospital during the period from February 2018 to February 2019. This study included 3 groups&#xD;
      subjected to different operations; each group consisted of 50 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective randomized study which was carried out in the department of General Surgery,&#xD;
      Minia University hospital during the period from February 2018 to February 2019. This study&#xD;
      included 3 groups subjected to different operations; each group consisted of 50 patients. Age&#xD;
      ranging from 20 to 50 years old and body weight ranging from 100 to 200 Kg, and subjected to&#xD;
      laparoscopic sleeve gastrectomy, mini gastric bypass and sleeve gastrectomy with loop&#xD;
      bipartition. Each patient was thoroughly evaluated by a multidisciplinary team (Nutritionist,&#xD;
      Endocrinologist, Psychologist, and Surgeon) using a standardized protocol. Follow up was done&#xD;
      after two weeks and after 2 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2021</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>surgeries</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hormonal change</measure>
    <time_frame>one year</time_frame>
    <description>GIT hormones (Ghrelin, secretin, PYY, GLP-1)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>laparoscopic sleeve gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>mini gastric bypass</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>sleeve gastrectomy with loop bipartition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sleeve gastrectomy with loop bipartition</intervention_name>
    <description>operations to decrease weight</description>
    <arm_group_label>laparoscopic sleeve gastrectomy</arm_group_label>
    <arm_group_label>mini gastric bypass</arm_group_label>
    <arm_group_label>sleeve gastrectomy with loop bipartition</arm_group_label>
    <other_name>minigastric bypass</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All morbid obese patients&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        GIT diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Minia university</name>
      <address>
        <city>Minya</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Minia University</last_name>
      <phone>(086) 2366149</phone>
      <email>minia.edu.org@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Amr Abdel Hameed El heny</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04414072
org study id: 367177
nct id: NCT04414072
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Many of the beneficial metabolic effects of bariatric surgery have been
      attributed to altered peptide hormone profiles, especially involving pancreatic and gut
      peptides.

      Objectives: assess the effects of bariatric procedures (sleeve gastrectomy, minigastric
      bypass and sleeve gastrectomy with loop bipartition) on GIT hormones. Methods: Prospective
      randomized study which was carried out in the department of General Surgery, Minia University
      hospital during the period from February 2018 to February 2019. This study included 3 groups
      subjected to different operations; each group consisted of 50 patients.
Prospective randomized study which was carried out in the department of General Surgery,
      Minia University hospital during the period from February 2018 to February 2019. This study
      included 3 groups subjected to different operations; each group consisted of 50 patients. Age
      ranging from 20 to 50 years old and body weight ranging from 100 to 200 Kg, and subjected to
      laparoscopic sleeve gastrectomy, mini gastric bypass and sleeve gastrectomy with loop
      bipartition. Each patient was thoroughly evaluated by a multidisciplinary team (Nutritionist,
      Endocrinologist, Psychologist, and Surgeon) using a standardized protocol. Follow up was done
      after two weeks and after 2 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: surgeries
primary purpose: Treatment
masking: Single (Participant)
measure: hormonal change
time frame: one year
description: GIT hormones (Ghrelin, secretin, PYY, GLP-1)
arm group label: laparoscopic sleeve gastrectomy
arm group type: Active Comparator
arm group label: mini gastric bypass
arm group type: Active Comparator
arm group label: sleeve gastrectomy with loop bipartition
arm group type: Active Comparator
intervention type: Procedure
intervention name: sleeve gastrectomy with loop bipartition
description: operations to decrease weight
arm group label: laparoscopic sleeve gastrectomy
arm group label: mini gastric bypass
arm group label: sleeve gastrectomy with loop bipartition
other name: minigastric bypass
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Amr Abdel Hameed El heny
investigator title: Assistant professor
mesh term: Obesity, Morbid
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code