xml: <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/NCT06015620</url>
    </required_header>
    <id_info>
      <org_study_id>AIIMSBBSR/PGThesis/2023-24/61</org_study_id>
      <nct_id>NCT06015620</nct_id>
    </id_info>
    <brief_title>Comorbidities Resolution After MGB Surgery and Change in Body Composition</brief_title>
    <acronym>MOGAMBO</acronym>
    <official_title>CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>All India Institute of Medical Sciences, Bhubaneswar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>All India Institute of Medical Sciences, Bhubaneswar</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>
        This observational study aims to learn about the correlation between the improving&#xD;
        comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in&#xD;
        body composition in morbidly obese patients. The main questions it aims to answer are:&#xD;
  &#xD;
        To study the correlation between the improving comorbidities associated with obesity after&#xD;
        MGB(Mini-Gastric Bypass) surgery and changes in body composition.&#xD;
  &#xD;
        Other objectives are:&#xD;
  &#xD;
          -  Changes in the parameters of the metabolic syndrome after surgery&#xD;
  &#xD;
          -  Changes in the cardiovascular risk biomarkers after metabolic surgery&#xD;
  &#xD;
          -  Emergence in complications arising out of surgery requiring any intervention or causing&#xD;
             a prolonged hospital stay, or requiring additional outpatient visits.&#xD;
  &#xD;
        Type of Study: An observational study in which participants with morbid obesity will undergo&#xD;
        mini-gastric bypass surgery as per routine protocol. No separate experimental interventions&#xD;
        will be done in the study for the participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Evidence supports that bariatric or metabolic surgery is more effective than conventional&#xD;
        therapy in controlling obesity and its related comorbidities. Although bariatric surgery has&#xD;
        been widely practised for many years worldwide, there is still a need to understand the&#xD;
        correlation between improving comorbidities associated with morbid obesity and body&#xD;
        composition change post-surgery. Amongst the comorbidities, type II diabetes, sleep apnea,&#xD;
        hypertension, and hypothyroidism are the significant ones associated with morbid obesity. A&#xD;
        disturbed quality of sleep results in daytime sleepiness, cardiac problems, renal problems,&#xD;
        etc., which in turn grossly reduces the work efficiency of an individual and increases&#xD;
        morbidity and mortality. From our experience, after a metabolic surgery (mini-gastric bypass&#xD;
        -MGB), the investigators find comorbidities, especially sleep apnoea and type II diabetes,&#xD;
        getting controlled early before significant weight loss has started. Also, there is an&#xD;
        improvement in the parameters of the metabolic syndrome after metabolic surgery. The&#xD;
        prospective cohort study aims to correlate the comorbidities resolution after mini-gastric&#xD;
        bypass surgery for morbid obesity and change in body composition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.</measure>
      <time_frame>3 years</time_frame>
      <description>The comorbidities associated with obesity like type2 diabetes, sleep apnea, dyslipidemia, hypothyroidism and other components of metabolic syndrome improves way ahead after the metabolic surgery as compared to an expected change in the body composition. This study will bring out the correlation between the change in body composition and the morbidity resolution.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in the parameters of the metabolic syndrome after surgery</measure>
      <time_frame>3 years</time_frame>
      <description>Components of the metabolic syndrome improve after metabolic surgery after different timelines. This study will bring out the time line of resolution of comorbidities after a metabolic surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the cardiovascular risk biomarkers after metabolic surgery</measure>
      <time_frame>3 years</time_frame>
      <description>Cardiovascular biomarkers like C reactive proteins (CRP) is stated to improve over time after a metabolic surgery. This study will find out the improvement in the CVS biomarker after the metabolic surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits</measure>
      <time_frame>3 years</time_frame>
      <description>The mini gastric bypass surgery done for morbid obesity is a malabsorption procedure done in patients suffering from morbid obesity. Expected changes in the post-operative patients are protein-energy malnutrition, essential vitamins like B12, D, etc, and mineral deficiency may occur. So a follow up of the patients in the post operative period will reveal any postoperative nutritional changes and there consequences.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Morbid Obesity</condition>
    <condition>Type2diabetes</condition>
    <condition>Sleep Apnea</condition>
    <condition>Hypothyroidism</condition>
    <condition>Hypertension</condition>
    <condition>Lipid Disorder</condition>
    <condition>Non-Alcoholic Fatty Liver Disease</condition>
    <condition>Chronic Venous Hypertension With Ulcer</condition>
    <arm_group>
      <arm_group_label>Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass)</arm_group_label>
      <description>The patients undergoing mini gastric bypass surgery for morbid obesity and its different comorbidities like type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, hypothyroidism and chronic venous hypertension.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Mini gastric bypass surgery</intervention_name>
      <description>Mini gastric bypass surgery is a common metabolic or bariatric surgery done world wide for patients suffering from morbid obesity not managed by non surgical modalities of treatment.</description>
      <arm_group_label>Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients suffering from morbid obesity and its associated comorbidities like type 2&#xD;
          diabetes, hypertension, obstructive sleep apnea, hypothyroidism, dyslipidemia and chronic&#xD;
          venous hypertension of the legs with its complications.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients undergoing laparoscopic MGB surgery for morbid obesity and it's&#xD;
               associated comorbidities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients not giving consent for the study&#xD;
  &#xD;
            -  All patients who were undergoing a redo-procedure for recurrence were excluded from&#xD;
               the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Prakash K Sasmal, MS, FACS</last_name>
      <role>Principal Investigator</role>
      <affiliation>All India Institute of Medical Sciences, Bhubaneswar, India</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Prakash K Sasmal, MS, FACS</last_name>
      <phone>+91 9438884255</phone>
      <email>drpksasmal@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Velugoti Sai Pradeep, MBBS</last_name>
      <phone>+91 6300465988</phone>
      <email>saiprad372@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Rudnicki Y, Slavin M, Keidar A, Kent I, Berkovich L, Tiomkin V, Inbar R, Avital S. The effect of bariatric surgery on hypothyroidism: Sleeve gastrectomy versus gastric bypass. Surg Obes Relat Dis. 2018 Sep;14(9):1297-1303. doi: 10.1016/j.soard.2018.06.008. Epub 2018 Jun 15.</citation>
      <PMID>30049595</PMID>
    </reference>
    <results_reference>
      <citation>Achamrah N, Colange G, Delay J, Rimbert A, Folope V, Petit A, Grigioni S, Dechelotte P, Coeffier M. Comparison of body composition assessment by DXA and BIA according to the body mass index: A retrospective study on 3655 measures. PLoS One. 2018 Jul 12;13(7):e0200465. doi: 10.1371/journal.pone.0200465. eCollection 2018.</citation>
      <PMID>30001381</PMID>
    </results_reference>
    <results_reference>
      <citation>Ravesloot MJ, Hilgevoord AA, van Wagensveld BA, de Vries N. Assessment of the effect of bariatric surgery on obstructive sleep apnea at two postoperative intervals. Obes Surg. 2014 Jan;24(1):22-31. doi: 10.1007/s11695-013-1023-y.</citation>
      <PMID>23856989</PMID>
    </results_reference>
    <results_reference>
      <citation>Fritscher LG, Canani S, Mottin CC, Fritscher CC, Berleze D, Chapman K, Chatkin JM. Bariatric surgery in the treatment of obstructive sleep apnea in morbidly obese patients. Respiration. 2007;74(6):647-52. doi: 10.1159/000107736. Epub 2007 Aug 29.</citation>
      <PMID>17728530</PMID>
    </results_reference>
    <results_reference>
      <citation>Cogollo VJ, Rivera CE, Valera RJ, Sarmiento-Cobos M, Montorfano L, Wasser E, Lo Menzo E, Szomstein S, Rosenthal RJ. Improvement of glucose metabolism following rapid weight loss after bariatric surgery and its impact on reduction of visceral abdominal fat versus free fat muscle. Surg Obes Relat Dis. 2021 May;17(5):933-938. doi: 10.1016/j.soard.2021.01.031. Epub 2021 Feb 2.</citation>
      <PMID>33715992</PMID>
    </results_reference>
    <results_reference>
      <citation>Snelder SM, Pouw N, Aga Y, Castro Cabezas M, Biter LU, Zijlstra F, Kardys I, van Dalen BM. Cardiovascular Biomarker Profiles in Obesity and Relation to Normalization of Subclinical Cardiac Dysfunction after Bariatric Surgery. Cells. 2022 Jan 26;11(3):422. doi: 10.3390/cells11030422.</citation>
      <PMID>35159232</PMID>
    </results_reference>
    <results_reference>
      <citation>Castanha CR, Tcbc-Pe AABF, Castanha AR, Belo GQMB, Lacerda RMR, Vilar L. Evaluation of quality of life, weight loss and comorbidities of patients undergoing bariatric surgery. Rev Col Bras Cir. 2018 Jul 16;45(3):e1864. doi: 10.1590/0100-6991e-20181864. English, Portuguese.</citation>
      <PMID>30020323</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>All India Institute of Medical Sciences, Bhubaneswar</investigator_affiliation>
      <investigator_full_name>Dr. Prakash Kumar Sasmal</investigator_full_name>
      <investigator_title>Additional Professor of General Surgery</investigator_title>
    </responsible_party>
    <keyword>morbid obesity</keyword>
    <keyword>OSA</keyword>
    <keyword>mini gastric bypass</keyword>
    <keyword>metabolic surgery</keyword>
    <keyword>polysomnography</keyword>
    <keyword>metabolic syndrome</keyword>
    <keyword>DEXA scan</keyword>
    <keyword>bioelectrical impedance</keyword>
    <keyword>body composition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Obesity, Morbid</mesh_term>
      <mesh_term>Lipid Metabolism Disorders</mesh_term>
      <mesh_term>Hypothyroidism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only the result of the study will be provided at the end. No individual patients detail will be revealed. However, the statistical analysis details, including the study protocol can be shared if required by any researcher.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015620
  org study id: AIIMSBBSR/PGThesis/2023-24/61
  nct id: NCT06015620
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This observational study aims to learn about the correlation between the improving
        comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in
        body composition in morbidly obese patients. The main questions it aims to answer are:
  
        To study the correlation between the improving comorbidities associated with obesity after
        MGB(Mini-Gastric Bypass) surgery and changes in body composition.
  
        Other objectives are:
  
          -  Changes in the parameters of the metabolic syndrome after surgery
  
          -  Changes in the cardiovascular risk biomarkers after metabolic surgery
  
          -  Emergence in complications arising out of surgery requiring any intervention or causing
             a prolonged hospital stay, or requiring additional outpatient visits.
  
        Type of Study: An observational study in which participants with morbid obesity will undergo
        mini-gastric bypass surgery as per routine protocol. No separate experimental interventions
        will be done in the study for the participants.
  Evidence supports that bariatric or metabolic surgery is more effective than conventional
        therapy in controlling obesity and its related comorbidities. Although bariatric surgery has
        been widely practised for many years worldwide, there is still a need to understand the
        correlation between improving comorbidities associated with morbid obesity and body
        composition change post-surgery. Amongst the comorbidities, type II diabetes, sleep apnea,
        hypertension, and hypothyroidism are the significant ones associated with morbid obesity. A
        disturbed quality of sleep results in daytime sleepiness, cardiac problems, renal problems,
        etc., which in turn grossly reduces the work efficiency of an individual and increases
        morbidity and mortality. From our experience, after a metabolic surgery (mini-gastric bypass
        -MGB), the investigators find comorbidities, especially sleep apnoea and type II diabetes,
        getting controlled early before significant weight loss has started. Also, there is an
        improvement in the parameters of the metabolic syndrome after metabolic surgery. The
        prospective cohort study aims to correlate the comorbidities resolution after mini-gastric
        bypass surgery for morbid obesity and change in body composition.
  observational model: Cohort
  time perspective: Prospective
  measure: To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.
  time frame: 3 years
  description: The comorbidities associated with obesity like type2 diabetes, sleep apnea, dyslipidemia, hypothyroidism and other components of metabolic syndrome improves way ahead after the metabolic surgery as compared to an expected change in the body composition. This study will bring out the correlation between the change in body composition and the morbidity resolution.
  measure: Changes in the parameters of the metabolic syndrome after surgery
  time frame: 3 years
  description: Components of the metabolic syndrome improve after metabolic surgery after different timelines. This study will bring out the time line of resolution of comorbidities after a metabolic surgery.
  measure: Changes in the cardiovascular risk biomarkers after metabolic surgery
  time frame: 3 years
  description: Cardiovascular biomarkers like C reactive proteins (CRP) is stated to improve over time after a metabolic surgery. This study will find out the improvement in the CVS biomarker after the metabolic surgery.
  measure: Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits
  time frame: 3 years
  description: The mini gastric bypass surgery done for morbid obesity is a malabsorption procedure done in patients suffering from morbid obesity. Expected changes in the post-operative patients are protein-energy malnutrition, essential vitamins like B12, D, etc, and mineral deficiency may occur. So a follow up of the patients in the post operative period will reveal any postoperative nutritional changes and there consequences.
  arm group label: Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass)
  description: The patients undergoing mini gastric bypass surgery for morbid obesity and its different comorbidities like type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, hypothyroidism and chronic venous hypertension.
  intervention type: Procedure
  intervention name: Mini gastric bypass surgery
  description: Mini gastric bypass surgery is a common metabolic or bariatric surgery done world wide for patients suffering from morbid obesity not managed by non surgical modalities of treatment.
  arm group label: Patients with morbid obesity undergoing metabolic surgery (Mini gastric bypass)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Prakash K Sasmal, MS, FACS
  role: Principal Investigator
  affiliation: All India Institute of Medical Sciences, Bhubaneswar, India
  last name: Prakash K Sasmal, MS, FACS
  phone: +91 9438884255
  email: drpksasmal@gmail.com
  last name: Velugoti Sai Pradeep, MBBS
  phone: +91 6300465988
  email: saiprad372@gmail.com
  citation: Rudnicki Y, Slavin M, Keidar A, Kent I, Berkovich L, Tiomkin V, Inbar R, Avital S. The effect of bariatric surgery on hypothyroidism: Sleeve gastrectomy versus gastric bypass. Surg Obes Relat Dis. 2018 Sep;14(9):1297-1303. doi: 10.1016/j.soard.2018.06.008. Epub 2018 Jun 15.
  PMID: 30049595
  citation: Achamrah N, Colange G, Delay J, Rimbert A, Folope V, Petit A, Grigioni S, Dechelotte P, Coeffier M. Comparison of body composition assessment by DXA and BIA according to the body mass index: A retrospective study on 3655 measures. PLoS One. 2018 Jul 12;13(7):e0200465. doi: 10.1371/journal.pone.0200465. eCollection 2018.
  PMID: 30001381
  citation: Ravesloot MJ, Hilgevoord AA, van Wagensveld BA, de Vries N. Assessment of the effect of bariatric surgery on obstructive sleep apnea at two postoperative intervals. Obes Surg. 2014 Jan;24(1):22-31. doi: 10.1007/s11695-013-1023-y.
  PMID: 23856989
  citation: Fritscher LG, Canani S, Mottin CC, Fritscher CC, Berleze D, Chapman K, Chatkin JM. Bariatric surgery in the treatment of obstructive sleep apnea in morbidly obese patients. Respiration. 2007;74(6):647-52. doi: 10.1159/000107736. Epub 2007 Aug 29.
  PMID: 17728530
  citation: Cogollo VJ, Rivera CE, Valera RJ, Sarmiento-Cobos M, Montorfano L, Wasser E, Lo Menzo E, Szomstein S, Rosenthal RJ. Improvement of glucose metabolism following rapid weight loss after bariatric surgery and its impact on reduction of visceral abdominal fat versus free fat muscle. Surg Obes Relat Dis. 2021 May;17(5):933-938. doi: 10.1016/j.soard.2021.01.031. Epub 2021 Feb 2.
  PMID: 33715992
  citation: Snelder SM, Pouw N, Aga Y, Castro Cabezas M, Biter LU, Zijlstra F, Kardys I, van Dalen BM. Cardiovascular Biomarker Profiles in Obesity and Relation to Normalization of Subclinical Cardiac Dysfunction after Bariatric Surgery. Cells. 2022 Jan 26;11(3):422. doi: 10.3390/cells11030422.
  PMID: 35159232
  citation: Castanha CR, Tcbc-Pe AABF, Castanha AR, Belo GQMB, Lacerda RMR, Vilar L. Evaluation of quality of life, weight loss and comorbidities of patients undergoing bariatric surgery. Rev Col Bras Cir. 2018 Jul 16;45(3):e1864. doi: 10.1590/0100-6991e-20181864. English, Portuguese.
  PMID: 30020323
  responsible party type: Principal Investigator
  investigator affiliation: All India Institute of Medical Sciences, Bhubaneswar
  investigator full name: Dr. Prakash Kumar Sasmal
  investigator title: Additional Professor of General Surgery
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Hypertension
  mesh term: Obesity
  mesh term: Obesity, Morbid
  mesh term: Lipid Metabolism Disorders
  mesh term: Hypothyroidism
  sharing ipd: No
  ipd description: Only the result of the study will be provided at the end. No individual patients detail will be revealed. However, the statistical analysis details, including the study protocol can be shared if required by any researcher.