<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/NCT04450472</url>
  </required_header>
  <id_info>
    <org_study_id>JinlingHospital</org_study_id>
    <nct_id>NCT04450472</nct_id>
  </id_info>
  <brief_title>Nonthyroidal Illness Syndrome in SBS</brief_title>
  <official_title>Nonthyroidal Illness Syndrome in Patients With Short Bowel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</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>
      Nonthyroidal illness syndrome (NTIS) is prevalent in critical illness; it is associated with&#xD;
      poor outcomes. However, few studies have focused on the relationship between NTIS and short&#xD;
      bowel syndrome (SBS). The aim of this study was to investigate the incidence, etiology, and&#xD;
      prognosis of NTIS and its correlation in clinical variables in adult patients with SBS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nonthyroidal illness syndrome (NTIS), also known as euthyroid sick syndrome or low&#xD;
      triiodothyronine (T3) syndrome, is a condition characterized by decreased serum&#xD;
      concentrations of T3 and low or normal plasma concentrations of thyroxine (T4) without a&#xD;
      compensatory increase in the serum levels of thyroid stimulating hormone (TSH). However, such&#xD;
      typical changes differ from those in primary or secondary thyroid disorders. NTIS refers to&#xD;
      distortions in thyroid function without thyroid disease caused by various critical illnesses.&#xD;
      This condition has been described in different acute and chronic disease states over the past&#xD;
      30 years, including sepsis, starvation, trauma, burns, myocardial infarction, Crohn's&#xD;
      disease, enterocutaneous fistulas, chronic kidney disease, and major surgery.&#xD;
&#xD;
      Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition&#xD;
      resulting from the loss of portions of the intestine, typically because of extensive surgical&#xD;
      resection or loss of intestinal function. Patients with SBS often stuffer from intestinal&#xD;
      insufficiency or intestinal failure because they are unable to maintain fluid and nutrient&#xD;
      balances on a normal diet. Therefore, SBS can cause various metabolic and physiologic&#xD;
      disturbances, many of which are associated with growth, intestinal adaptation, and hormone&#xD;
      secretion. Many previous studies of SBS have evaluated growth hormone, glucagon-like&#xD;
      peptide-1, glucagon-like peptide-2, vitamin D and parathyroid hormone, peptide YY, and&#xD;
      ghrelin. However, few studies have reported the association between SBS and the&#xD;
      hypothalamic-pituitary-thyroid axis and its balance.&#xD;
&#xD;
      The present study was performed to evaluate the association of thyroid hormone disturbance&#xD;
      and SBS in adult patients. Because NTIS is the main type of thyroid hormone disturbance, we&#xD;
      further investigated the incidence, underlying mechanisms, and correlation with clinical&#xD;
      variables and prognosis of NTIS in adult patients with SBS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Thyroid function index</measure>
    <time_frame>Within one week of patients enrollment.</time_frame>
    <description>Thyroid function assessment includes level of free triiodothyronine (FT3), total triiodothyronine (TT3), free thyroxin (FT4), total thyroxin (TT4), thyroid stimulating hormone (TSH).</description>
  </primary_outcome>
  <enrollment type="Actual">51</enrollment>
  <condition>Nonthyroidal Illness Syndrome</condition>
  <condition>Short Bowel Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with SBS admitted to a clinical nutrition center in a tertiary referral hospital&#xD;
        were identified to evaluate the incidence of NTIS and to explore its correlation with&#xD;
        clinical variables and prognosis in adult patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) Adult patients with SBS, defined as intestinal malabsorption disorder resulting from&#xD;
        extensive bowel resection with a remnant small intestine length of greater than 200 cm,&#xD;
        admitted to a clinical nutrition center.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age less than 18 years;&#xD;
&#xD;
          2. previous history of thyroidal, hypophyseal or hypothalamic disease;&#xD;
&#xD;
          3. lactational or gestational period;&#xD;
&#xD;
          4. medication history of thyroidal hormone or antithyroid drugs;&#xD;
&#xD;
          5. craniocerebral injury;&#xD;
&#xD;
          6. attack of coronary heart disease, myocardial, or cerebral infarction in the past&#xD;
             month;&#xD;
&#xD;
          7. intracranial infection or hemorrhage in the past month. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Wang Xinying</investigator_full_name>
    <investigator_title>Director of the clinical nutrition center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Short Bowel Syndrome</mesh_term>
    <mesh_term>Euthyroid Sick Syndromes</mesh_term>
    <mesh_term>Syndrome</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/NCT04450472
org study id: JinlingHospital
nct id: NCT04450472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nonthyroidal illness syndrome (NTIS) is prevalent in critical illness; it is associated with
      poor outcomes. However, few studies have focused on the relationship between NTIS and short
      bowel syndrome (SBS). The aim of this study was to investigate the incidence, etiology, and
      prognosis of NTIS and its correlation in clinical variables in adult patients with SBS.
Nonthyroidal illness syndrome (NTIS), also known as euthyroid sick syndrome or low
      triiodothyronine (T3) syndrome, is a condition characterized by decreased serum
      concentrations of T3 and low or normal plasma concentrations of thyroxine (T4) without a
      compensatory increase in the serum levels of thyroid stimulating hormone (TSH). However, such
      typical changes differ from those in primary or secondary thyroid disorders. NTIS refers to
      distortions in thyroid function without thyroid disease caused by various critical illnesses.
      This condition has been described in different acute and chronic disease states over the past
      30 years, including sepsis, starvation, trauma, burns, myocardial infarction, Crohn's
      disease, enterocutaneous fistulas, chronic kidney disease, and major surgery.

      Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition
      resulting from the loss of portions of the intestine, typically because of extensive surgical
      resection or loss of intestinal function. Patients with SBS often stuffer from intestinal
      insufficiency or intestinal failure because they are unable to maintain fluid and nutrient
      balances on a normal diet. Therefore, SBS can cause various metabolic and physiologic
      disturbances, many of which are associated with growth, intestinal adaptation, and hormone
      secretion. Many previous studies of SBS have evaluated growth hormone, glucagon-like
      peptide-1, glucagon-like peptide-2, vitamin D and parathyroid hormone, peptide YY, and
      ghrelin. However, few studies have reported the association between SBS and the
      hypothalamic-pituitary-thyroid axis and its balance.

      The present study was performed to evaluate the association of thyroid hormone disturbance
      and SBS in adult patients. Because NTIS is the main type of thyroid hormone disturbance, we
      further investigated the incidence, underlying mechanisms, and correlation with clinical
      variables and prognosis of NTIS in adult patients with SBS.
observational model: Cohort
time perspective: Retrospective
measure: Thyroid function index
time frame: Within one week of patients enrollment.
description: Thyroid function assessment includes level of free triiodothyronine (FT3), total triiodothyronine (TT3), free thyroxin (FT4), total thyroxin (TT4), thyroid stimulating hormone (TSH).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Wang Xinying
investigator title: Director of the clinical nutrition center
mesh term: Short Bowel Syndrome
mesh term: Euthyroid Sick Syndromes
mesh term: Syndrome