Nonthyroidal Illness Syndrome in SBS

Sponsor
Jinling Hospital, China (Other)
Overall Status
Completed
CT.gov ID
NCT04450472
Collaborator
(none)
51
24

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    51 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Nonthyroidal Illness Syndrome in Patients With Short Bowel Syndrome
    Actual Study Start Date :
    Dec 31, 2016
    Actual Primary Completion Date :
    Dec 31, 2018
    Actual Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Thyroid function index [Within one week of patients enrollment.]

      Thyroid function assessment includes level of free triiodothyronine (FT3), total triiodothyronine (TT3), free thyroxin (FT4), total thyroxin (TT4), thyroid stimulating hormone (TSH).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    (1) Adult patients with SBS, defined as intestinal malabsorption disorder resulting from extensive bowel resection with a remnant small intestine length of greater than 200 cm, admitted to a clinical nutrition center.

    -

    Exclusion Criteria:
    1. age less than 18 years;

    2. previous history of thyroidal, hypophyseal or hypothalamic disease;

    3. lactational or gestational period;

    4. medication history of thyroidal hormone or antithyroid drugs;

    5. craniocerebral injury;

    6. attack of coronary heart disease, myocardial, or cerebral infarction in the past month;

    7. intracranial infection or hemorrhage in the past month. -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Jinling Hospital, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wang Xinying, Director of the clinical nutrition center, Jinling Hospital, China
    ClinicalTrials.gov Identifier:
    NCT04450472
    Other Study ID Numbers:
    • JinlingHospital
    First Posted:
    Jun 29, 2020
    Last Update Posted:
    Jun 29, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 29, 2020