<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/NCT01729130</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 09-043</org_study_id>
    <nct_id>NCT01729130</nct_id>
  </id_info>
  <brief_title>Adipose Tissue Function After Pancreas Transplantation</brief_title>
  <official_title>A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do&#xD;
      not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is&#xD;
      a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular&#xD;
      disease (CVD). These biomarkers also can become additional outcome measures for an&#xD;
      intervention such as pancreatic/kidney transplant. If biological markers show an improvement&#xD;
      with an intervention before anthropometric changes occur, intermediate outcomes can be an&#xD;
      encouraging finding for practitioners. This study will focus on the central question of&#xD;
      &quot;adipose tissue dysfunction&quot; as mediator of metabolic complications of positive energy&#xD;
      balance, independent of body fat content and distribution. This study will address the&#xD;
      question of effect of hyperglycemia on adipose tissue function independent of body fat mass.&#xD;
      This project will take advantage of unique expertise of our investigators to perform detailed&#xD;
      metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The&#xD;
      results of the proposed study will provide support to the novel approach of identifying&#xD;
      adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of&#xD;
      diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary&#xD;
      preliminary data for future grant submissions to support our central hypothesis and develop&#xD;
      stronger interactions within and outside The University of Texas Medical Branch (UTMB) with&#xD;
      clinical investigators in the area of DM and its complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      detailed description is his protocol&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">February 19, 2019</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Change in body fat distribution</measure>
    <time_frame>1 year post transplantation</time_frame>
    <description>skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Group 1 Pancreas/kidney transplant</arm_group_label>
    <description>Group 1 of patients with End Stage Renal Disease (ESRD) and Diabetes Mellitis who will receive a pancreas and kidney transplant. An adipose tissue biopsy and blood samples are collected at time of transplant surgery. A repeat adipose tissue needle biopsy and blood samples are collected between 3-12 months post transplant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 DM with kidney transplant</arm_group_label>
    <description>Group 2 are patient with DM and ESRD and who will receive only a kidney transplant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 No DM and kidney transplant</arm_group_label>
    <description>Group 3 will be patients who do not have DM but do have the diagnosis of ESRD and will receive only a kidney transplant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adipose tissue biopsy</intervention_name>
    <description>Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.</description>
    <arm_group_label>Group 1 Pancreas/kidney transplant</arm_group_label>
    <arm_group_label>Group 2 DM with kidney transplant</arm_group_label>
    <arm_group_label>Group 3 No DM and kidney transplant</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      adipose tissue blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that have Diabetes mellitis and End Stage Renal Disease who will be receiving&#xD;
        pancreas/kidney or only kidney transplantation.&#xD;
&#xD;
        Patients that have End Stage Renal Disease and who will be receiving an isolated kidney&#xD;
        transplant. This control group will account for effects of immuno-suppression and for&#xD;
        potential metabolic changes induced by the kidney transplant on adipose tissue function.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women of any ethnicity, and age between 18 and 65 years.&#xD;
&#xD;
          2. Patients with diabetes and renal failure who have been scheduled kidney-pancreas or&#xD;
             isolated kidney transplantation.&#xD;
&#xD;
          3. Ability to speak read and understand English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as&#xD;
             assessed by history and physical examination and laboratory testing.&#xD;
&#xD;
          2. Any personal history of substance abuse (reported only).&#xD;
&#xD;
          3. Alcohol intake above 7 grams/day.&#xD;
&#xD;
          4. Pregnancy or lactation.&#xD;
&#xD;
          5. Inability to give consent for this study.&#xD;
&#xD;
             -&#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>Luca Cicalese, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Medical Branch (UTMB)</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729130
org study id: IRB 09-043
nct id: NCT01729130
lead sponsor: 
has dmc: No
Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do
      not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is
      a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular
      disease (CVD). These biomarkers also can become additional outcome measures for an
      intervention such as pancreatic/kidney transplant. If biological markers show an improvement
      with an intervention before anthropometric changes occur, intermediate outcomes can be an
      encouraging finding for practitioners. This study will focus on the central question of
      "adipose tissue dysfunction" as mediator of metabolic complications of positive energy
      balance, independent of body fat content and distribution. This study will address the
      question of effect of hyperglycemia on adipose tissue function independent of body fat mass.
      This project will take advantage of unique expertise of our investigators to perform detailed
      metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The
      results of the proposed study will provide support to the novel approach of identifying
      adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of
      diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary
      preliminary data for future grant submissions to support our central hypothesis and develop
      stronger interactions within and outside The University of Texas Medical Branch (UTMB) with
      clinical investigators in the area of DM and its complications.
detailed description is his protocol
observational model: Cohort
time perspective: Prospective
measure: Change in body fat distribution
time frame: 1 year post transplantation
description: skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers
arm group label: Group 1 Pancreas/kidney transplant
description: Group 1 of patients with End Stage Renal Disease (ESRD) and Diabetes Mellitis who will receive a pancreas and kidney transplant. An adipose tissue biopsy and blood samples are collected at time of transplant surgery. A repeat adipose tissue needle biopsy and blood samples are collected between 3-12 months post transplant.
arm group label: Group 2 DM with kidney transplant
description: Group 2 are patient with DM and ESRD and who will receive only a kidney transplant.
arm group label: Group 3 No DM and kidney transplant
description: Group 3 will be patients who do not have DM but do have the diagnosis of ESRD and will receive only a kidney transplant.
intervention type: Procedure
intervention name: Adipose tissue biopsy
description: Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.
arm group label: Group 1 Pancreas/kidney transplant
arm group label: Group 2 DM with kidney transplant
arm group label: Group 3 No DM and kidney transplant
adipose tissue blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Luca Cicalese, MD
role: Principal Investigator
affiliation: UTMB
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1