- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450472
Nonthyroidal Illness Syndrome in SBS
Nonthyroidal Illness Syndrome in Patients With Short Bowel Syndrome
Study Overview
Status
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
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Exclusion Criteria:
- age less than 18 years;
- previous history of thyroidal, hypophyseal or hypothalamic disease;
- lactational or gestational period;
- medication history of thyroidal hormone or antithyroid drugs;
- craniocerebral injury;
- attack of coronary heart disease, myocardial, or cerebral infarction in the past month;
- intracranial infection or hemorrhage in the past month. -
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thyroid function index
Time Frame: Within one week of patients enrollment.
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Thyroid function assessment includes level of free triiodothyronine (FT3), total triiodothyronine (TT3), free thyroxin (FT4), total thyroxin (TT4), thyroid stimulating hormone (TSH).
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Within one week of patients enrollment.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JinlingHospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Short Bowel Syndrome
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Marathon Pharmaceuticals, LLCWithdrawnShort Bowel Syndrome | Short Gut Syndrome | SBS | Short Gut | Short BowelUnited States
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Central Hospital, Nancy, FranceBeaujon Hospital; Société Francophone Nutrition Clinique et MétabolismeUnknownSBS - Short Bowel SyndromeFrance
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TakedaCompletedShort Bowel Syndrome (SBS)Brazil
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TakedaRecruitingShort Bowel Syndrome (SBS)Canada
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GlyPharma TherapeuticsVectivBio AGCompletedSBS - Short Bowel SyndromeDenmark
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ShireRecruitingShort Bowel Syndrome (SBS)United States
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Marathon Pharmaceuticals, LLCWithdrawnShort Bowel Syndrome | Short Gut Syndrome | SBS | Short GutUnited States
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University of Texas Southwestern Medical CenterChildren's Hospital of PhiladelphiaNot yet recruitingShort Gut Syndrome
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Children's Hospital of PhiladelphiaUniversity of PennsylvaniaRecruiting
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University of MiamiQOL Medical, LLCRecruitingShort Gut SyndromeUnited States