Nonthyroidal Illness Syndrome in SBS

June 25, 2020 updated by: Wang Xinying, Jinling Hospital, China

Nonthyroidal Illness Syndrome in Patients With Short Bowel Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with SBS admitted to a clinical nutrition center in a tertiary referral hospital were identified to evaluate the incidence of NTIS and to explore its correlation with clinical variables and prognosis in adult patients.

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thyroid function index
Time Frame: 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).
Within one week of patients enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JinlingHospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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