<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/NCT03301545</url>
  </required_header>
  <id_info>
    <org_study_id>HS20519 (B2017:023)</org_study_id>
    <nct_id>NCT03301545</nct_id>
  </id_info>
  <brief_title>The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population</brief_title>
  <official_title>The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</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>
      Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly&#xD;
      co-occur and are associated with significant morbidity, mortality, and health care&#xD;
      expenditures. The Indigenous (First Nations, Metis and Inuit) population bears a&#xD;
      disproportionate burden of T2DM in Canada. The prevalence of obesity among Indigenous&#xD;
      individuals is approximately 31.2% compared to 18.6% for the non-Indigenous population. In&#xD;
      2011, 16.7% of Manitoba's population, or four times the Canadian average, identified as&#xD;
      Indigenous. At the same time, prevalence of T2DM in Manitoba is on the rise. Bariatric&#xD;
      surgery is an effective treatment modality for the improvement and resolution of T2DM in&#xD;
      patients who are obese. We aim to compare the effectiveness of bariatric surgery with&#xD;
      conventional medical treatment in treating metabolic diseases in Indigenous people; the&#xD;
      findings of which will assist in future treatment and program planning. Our objective is to&#xD;
      determine whether Manitoba's urban Indigenous population will achieve better diabetic control&#xD;
      and improved rates of remission of T2DM with bariatric surgery compared to best diabetic&#xD;
      medical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly&#xD;
      co-occur and are associated with significant morbidity, mortality, and health care&#xD;
      expenditures. The Indigenous population bears a disproportionate burden of T2DM in Canada.&#xD;
      The 2007/2008 Canadian Community Health Survey (Statistics Canada) reported the prevalence of&#xD;
      obesity among Indigenous individuals is approximately 31.2% compared to 18.6% for the&#xD;
      non-Indigenous population. In 2011, 16.7% of Manitoba's population, or four times the&#xD;
      Canadian average, identified as Indigenous (Statistics Canada). At the same time, prevalence&#xD;
      of T2DM in Manitoba is on the rise. Bariatric surgery is an effective treatment modality for&#xD;
      the improvement and resolution of T2DM in patients who are obese. To date, there are no&#xD;
      published studies comparing the effectiveness of bariatric surgery with conventional medical&#xD;
      treatment in treating metabolic diseases in Indigenous people.&#xD;
&#xD;
      Our objective is to determine whether Manitoba's urban Indigenous population will achieve&#xD;
      better diabetic control and improved rates of remission of T2DM with bariatric surgery&#xD;
      compared to best diabetic medical care (Manitoba Diabetes Care Recommendations, 2010;&#xD;
      consistent with the Diabetes Canada and Clinical Practice Guidelines). Our primary outcome is&#xD;
      best diabetic control at one-year post-intervention, as measured by fasting plasma glucose&#xD;
      and hemaglobin A1c (HbA1c). Secondary outcomes will include changes in diabetic medication&#xD;
      use, mean weight loss, and percentage changes in blood pressure, waist circumference&#xD;
      measurement changes, and levels of fasting blood lipids (total cholesterol, HDL, LDL, and&#xD;
      triglycerides). Additional funding to extend the study to include follow-up of study&#xD;
      participants at five years post-treatment through accessing their medical charts and&#xD;
      anonymized administrative data will be sought.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Patients consenting to participate will be randomized to one of two groups: (1) fast-track to bariatric surgery, or (2) Best diabetic care under the guidance of an endocrinologist for one year. Note: participants in the best diabetic care group will have the option to undergo bariatric surgery after one year if desired.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Each study participant will be assigned a unique study identification number (study ID). All information/data regarding the participant will be collected using the Study ID. In this way, data analyses by the outcomes assessor will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fasting Blood Glucose</measure>
    <time_frame>Baseline,3, 6, 9, and 12 months for all patients</time_frame>
    <description>Change from baseline fasting blood glucose level at 3, 6, 9, and 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Glycosylated Hemoglobin (HbA1c)</measure>
    <time_frame>Baseline,3, 6, 9, and 12 months for all patients</time_frame>
    <description>Change from baseline Glycosylated Hemoglobin (HbA1c) at 3, 6, 9, and 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetic Medication</measure>
    <time_frame>Baseline,3, 6, 9, and 12 months for all patients</time_frame>
    <description>Change from baseline in the number and dose of diabetic medication at 3, 6, 9, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Weight Loss</measure>
    <time_frame>Baseline, at 3, 6, 9, and 12 months for all patients</time_frame>
    <description>Change from baseline in total amount of weight lost at 3, 6, 9, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Percentage Change in Blood Pressure</measure>
    <time_frame>Baseline, at 3, 6, 9, and 12 months for all patients</time_frame>
    <description>Change in Blood Pressure (percentage of initial pre-surgery blood pressure) at 3, 6, 9, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Circumference</measure>
    <time_frame>Baseline, at 3, 6, 9, and 12 months for all patients</time_frame>
    <description>Change in waist circumference (cm) from baseline at 3, 6, 9, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Blood Lipids</measure>
    <time_frame>Baseline, at 3, 6, 9, and 12 months for all patients</time_frame>
    <description>Change in total, LDL, HDL, and triacylglycerides from baseline at 3, 6, 9, and 12 months</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <condition>Obesity</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Fast-Track to Bariatric Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo standard of care for bariatric surgery patients in Manitoba and receive preoperative evaluation by the Centre for Metabolic and Bariatric Surgery (CMBS) team of nurses, dietitians, psychologist, and kinesiologist. Patients must attend the standard appointments and achieve the personalized program goals to be approved for laparoscopic Roux-En-Y gastric bypass surgery. Once approved, one of four surgeons performs surgery (within 12 months of randomization). Patients are followed post-operatively (by surgeon) at 6 weeks, and at 6 and 12 months. Pharmacologic glycemic control will be determined by an endocrinologist as per a standardized post-operative protocol. Post-procedural multidisciplinary follow-up occurs based on established CMBS guidelines (phone call 1 week post-operatively and an appointment at 3 and 12 months). Patients receive surgery within the current publically funded bariatric surgery program; no additional direct costs incurred by the patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Best Diabetic Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive the best available medical practice for the treatment, education, and follow-up T2DM based on Manitoba Diabetes Care Recommendations and Diabetes Canada's clinical practice guidelines. Patients will have access to a general physician, endocrinologist, and a diabetes education nurse. An Endocrinologist will deliver the program to patients. Diabetes care, education and self-management support services will be provided by the Victoria General Hospital (VGH) Diabetes Education Centre; led by a registered nurse and dietitian. Patients will undergo individual diabetes management instruction which may include counseling on topics such as diet, exercise, smoking cessation, medications, diabetic complications, and blood sugar testing. Medical therapies, including pharmaceutical agents, will be determined on an individual basis as per standard protocol. There will be no direct patient-related medication costs (publicly funded).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retrospective Cohort</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A retrospective cohort of non-Indigenous bariatric surgery patients from the Centre for Metabolic and Bariatric Surgery Program will allow comparison with the intervention group. The cohort will be age and gender matched.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fast-Track to Bariatric Surgery</intervention_name>
    <description>30 participants from the urban Indigenous community who have Type 2 diabetes and are candidates for bariatric surgery at the Centre for Metabolic and Bariatric Surgery will be randomized to the fast-track to bariatric surgery group.</description>
    <arm_group_label>Fast-Track to Bariatric Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Urban Indigenous patient&#xD;
&#xD;
          -  18 to 55 years of age&#xD;
&#xD;
          -  male of female&#xD;
&#xD;
          -  Body Mass Index = or &gt; 35 to 55 Kg/m2&#xD;
&#xD;
          -  Confirmed diagnosis of Type II diabetes mellitus (HbA1c of 7.0% for at least one year)&#xD;
&#xD;
          -  Referred and accepted as into the Centre for Metabolic and Bariatric Surgery Program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently a smoker&#xD;
&#xD;
          -  Body Mass Index above 55 Kg/m2&#xD;
&#xD;
          -  Diagnosed with Type I diabetes mellitus&#xD;
&#xD;
          -  Have had previous bariatric surgery&#xD;
&#xD;
          -  Have contraindications to laparoscopic and/or bariatric surgery&#xD;
&#xD;
          -  Rural patients; due to lack of rural Indigenous community-based support necessary for&#xD;
             bariatric surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krista M Hardy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba; Dept of Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Krista M Hardy, MD</last_name>
    <phone>204-237-2574</phone>
    <email>khardy@sbgh.mb.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kathleen M Clouston, PhD</last_name>
    <phone>204-258-1479</phone>
    <email>kclouston@sbgh.mb.ca</email>
  </overall_contact_backup>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>April 3, 2020</last_update_submitted>
  <last_update_submitted_qc>April 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Obesity</keyword>
  <keyword>Type 2 Diabetes Mellitus</keyword>
  <keyword>Indigenous Population</keyword>
  <keyword>Randomized Control Trial</keyword>
  <keyword>Glycoslyated Hemoglobin A1C</keyword>
  <keyword>Anthropometric measurements</keyword>
  <keyword>Medication Use</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>Undecided</sharing_ipd>
    <ipd_description>Will be carried out according to University of Manitoba and Winnipeg Regional Health Authority applicable policies.</ipd_description>
  </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/NCT03301545
org study id: HS20519 (B2017:023)
nct id: NCT03301545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly
      co-occur and are associated with significant morbidity, mortality, and health care
      expenditures. The Indigenous (First Nations, Metis and Inuit) population bears a
      disproportionate burden of T2DM in Canada. The prevalence of obesity among Indigenous
      individuals is approximately 31.2% compared to 18.6% for the non-Indigenous population. In
      2011, 16.7% of Manitoba's population, or four times the Canadian average, identified as
      Indigenous. At the same time, prevalence of T2DM in Manitoba is on the rise. Bariatric
      surgery is an effective treatment modality for the improvement and resolution of T2DM in
      patients who are obese. We aim to compare the effectiveness of bariatric surgery with
      conventional medical treatment in treating metabolic diseases in Indigenous people; the
      findings of which will assist in future treatment and program planning. Our objective is to
      determine whether Manitoba's urban Indigenous population will achieve better diabetic control
      and improved rates of remission of T2DM with bariatric surgery compared to best diabetic
      medical care.
Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly
      co-occur and are associated with significant morbidity, mortality, and health care
      expenditures. The Indigenous population bears a disproportionate burden of T2DM in Canada.
      The 2007/2008 Canadian Community Health Survey (Statistics Canada) reported the prevalence of
      obesity among Indigenous individuals is approximately 31.2% compared to 18.6% for the
      non-Indigenous population. In 2011, 16.7% of Manitoba's population, or four times the
      Canadian average, identified as Indigenous (Statistics Canada). At the same time, prevalence
      of T2DM in Manitoba is on the rise. Bariatric surgery is an effective treatment modality for
      the improvement and resolution of T2DM in patients who are obese. To date, there are no
      published studies comparing the effectiveness of bariatric surgery with conventional medical
      treatment in treating metabolic diseases in Indigenous people.

      Our objective is to determine whether Manitoba's urban Indigenous population will achieve
      better diabetic control and improved rates of remission of T2DM with bariatric surgery
      compared to best diabetic medical care (Manitoba Diabetes Care Recommendations, 2010;
      consistent with the Diabetes Canada and Clinical Practice Guidelines). Our primary outcome is
      best diabetic control at one-year post-intervention, as measured by fasting plasma glucose
      and hemaglobin A1c (HbA1c). Secondary outcomes will include changes in diabetic medication
      use, mean weight loss, and percentage changes in blood pressure, waist circumference
      measurement changes, and levels of fasting blood lipids (total cholesterol, HDL, LDL, and
      triglycerides). Additional funding to extend the study to include follow-up of study
      participants at five years post-treatment through accessing their medical charts and
      anonymized administrative data will be sought.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients consenting to participate will be randomized to one of two groups: (1) fast-track to bariatric surgery, or (2) Best diabetic care under the guidance of an endocrinologist for one year. Note: participants in the best diabetic care group will have the option to undergo bariatric surgery after one year if desired.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Each study participant will be assigned a unique study identification number (study ID). All information/data regarding the participant will be collected using the Study ID. In this way, data analyses by the outcomes assessor will be blinded.
measure: Change in Fasting Blood Glucose
time frame: Baseline,3, 6, 9, and 12 months for all patients
description: Change from baseline fasting blood glucose level at 3, 6, 9, and 12 months
measure: Change in Glycosylated Hemoglobin (HbA1c)
time frame: Baseline,3, 6, 9, and 12 months for all patients
description: Change from baseline Glycosylated Hemoglobin (HbA1c) at 3, 6, 9, and 12 months
measure: Change in Diabetic Medication
time frame: Baseline,3, 6, 9, and 12 months for all patients
description: Change from baseline in the number and dose of diabetic medication at 3, 6, 9, and 12 months
measure: Change in Mean Weight Loss
time frame: Baseline, at 3, 6, 9, and 12 months for all patients
description: Change from baseline in total amount of weight lost at 3, 6, 9, and 12 months
measure: Change in the Percentage Change in Blood Pressure
time frame: Baseline, at 3, 6, 9, and 12 months for all patients
description: Change in Blood Pressure (percentage of initial pre-surgery blood pressure) at 3, 6, 9, and 12 months
measure: Change in Waist Circumference
time frame: Baseline, at 3, 6, 9, and 12 months for all patients
description: Change in waist circumference (cm) from baseline at 3, 6, 9, and 12 months
measure: Change in Fasting Blood Lipids
time frame: Baseline, at 3, 6, 9, and 12 months for all patients
description: Change in total, LDL, HDL, and triacylglycerides from baseline at 3, 6, 9, and 12 months
arm group label: Fast-Track to Bariatric Surgery
arm group type: Active Comparator
description: Patients will undergo standard of care for bariatric surgery patients in Manitoba and receive preoperative evaluation by the Centre for Metabolic and Bariatric Surgery (CMBS) team of nurses, dietitians, psychologist, and kinesiologist. Patients must attend the standard appointments and achieve the personalized program goals to be approved for laparoscopic Roux-En-Y gastric bypass surgery. Once approved, one of four surgeons performs surgery (within 12 months of randomization). Patients are followed post-operatively (by surgeon) at 6 weeks, and at 6 and 12 months. Pharmacologic glycemic control will be determined by an endocrinologist as per a standardized post-operative protocol. Post-procedural multidisciplinary follow-up occurs based on established CMBS guidelines (phone call 1 week post-operatively and an appointment at 3 and 12 months). Patients receive surgery within the current publically funded bariatric surgery program; no additional direct costs incurred by the patients.
arm group label: Best Diabetic Care Group
arm group type: No Intervention
description: Patients will receive the best available medical practice for the treatment, education, and follow-up T2DM based on Manitoba Diabetes Care Recommendations and Diabetes Canada's clinical practice guidelines. Patients will have access to a general physician, endocrinologist, and a diabetes education nurse. An Endocrinologist will deliver the program to patients. Diabetes care, education and self-management support services will be provided by the Victoria General Hospital (VGH) Diabetes Education Centre; led by a registered nurse and dietitian. Patients will undergo individual diabetes management instruction which may include counseling on topics such as diet, exercise, smoking cessation, medications, diabetic complications, and blood sugar testing. Medical therapies, including pharmaceutical agents, will be determined on an individual basis as per standard protocol. There will be no direct patient-related medication costs (publicly funded).
arm group label: Retrospective Cohort
arm group type: No Intervention
description: A retrospective cohort of non-Indigenous bariatric surgery patients from the Centre for Metabolic and Bariatric Surgery Program will allow comparison with the intervention group. The cohort will be age and gender matched.
intervention type: Procedure
intervention name: Fast-Track to Bariatric Surgery
description: 30 participants from the urban Indigenous community who have Type 2 diabetes and are candidates for bariatric surgery at the Centre for Metabolic and Bariatric Surgery will be randomized to the fast-track to bariatric surgery group.
arm group label: Fast-Track to Bariatric Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Krista M Hardy, MD
role: Principal Investigator
affiliation: University of Manitoba; Dept of Surgery
last name: Krista M Hardy, MD
phone: 204-237-2574
email: khardy@sbgh.mb.ca
last name: Kathleen M Clouston, PhD
phone: 204-258-1479
email: kclouston@sbgh.mb.ca
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided
ipd description: Will be carried out according to University of Manitoba and Winnipeg Regional Health Authority applicable policies.