The Clinical Incidence of Low Triiodothyronine SyndromeNCT02452073
An Analysis of the Relative Risk for Low Triiodothyronine Syndrome in Patients With Chronic Radiation Enteritis
An observational study of The Clinical Incidence of Low Triiodothyronine Syndrome, run by Shengxian Fan.
Trial summary
Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due to the dosage of radiation, sensitivity of organs to radiation, and some patient characteristics, RE can present as either an acute or… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- The Clinical Incidence of Low Triiodothyronine Syndrome
- What is being tested?
- Thyroid function tests
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients and volunteers who were admitted to our hospital
Who may be able to join
- patients with chronic radiation enteritis
- patients with some kinds of malignant tumors but had not previously received radiotherapy
- age-matched healthy volunteers
Who cannot join
- Patients with a chronic disease other than CRE, including RA, SLE, thyroid illness, infectious diseases, and hepatic or renal disorders were excluded.
- patients have taken any drugs that may influence thyroid hormone secretion and metabolism during the previous 3 months.
About this study
Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due to the dosage of radiation, sensitivity of organs to radiation, and some patient characteristics, RE can present as either an acute or chronic syndrome. Clinical manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia, intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant percentage of patients with rectosigmoid and genitourinary system tumors. Different techniques have been developed to prevent the occurrence of radiation induced injury. However, the incidence of CRE is expected to continue to rise during the coming years. What's more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE, such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention is only paid to local complications, there is little report on systemic damage of abdominal or pelvic radiotherapy.
Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is variously known as the "nonthyroidal illness syndrome (NTIS)". This condition is frequently detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid hormone metabolism might change during many chronic illnesses as early as 1973. Data has shown that about 35-70% of acute and chronic critical conditions were associated with a significant abnormal thyroid hormone metabolism, of which LT3S was the most common type. Furthermore, these changes have been shown to be associated with disease severity and have been connected with poor short-term prognosis.
To date, there are lots of literatures include detailed reports on the relationship between LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus, sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE patients.
- Being tested
- Thyroid function tests
- Keywords
- low triiodothyronine syndrome, chronic radiation enteritis, triiodothyronine, thyroxine, thyroid stimulating hormone
- Medical subject headings
- Euthyroid Sick Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid function testsOther
| Study group | Role | What they receive |
|---|---|---|
| CRE group | patients with chronic radiation enteritis Receives: Other: Thyroid function tests | |
| malignancy group | patients with some kinds of malignant tumors but had not previously received radiotherapy Receives: Other: Thyroid function tests | |
| control group | age-matched healthy volunteers Receives: Other: Thyroid function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
The results will be expressed as percentage
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Clinical Incidence of Low Triiodothyronine SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengxian Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shengxian Fan, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452073
- Sponsor's protocol ID
- JinlingH
- Status last verified
- May 2015
- First submitted
- 15 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Relative Risk for Low Triiodothyronine Syndrome in Patients With Chronic Radiation Enteritis
- ClinicalTrials.gov ID
- NCT02452073
- Acronym / sponsor ID
- JinlingH
- Keywords
- low triiodothyronine syndrome, chronic radiation enteritis, triiodothyronine, thyroxine, thyroid stimulating hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shengxian FanUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due to the dosage of radiation, sensitivity of organs to radiation, and some patient characteristics, RE can present as either an acute or chronic syndrome. Clinical manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia, intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant percentage of patients with rectosigmoid and genitourinary system tumors. Different techniques have been developed to prevent the occurrence of radiation induced injury. However, the incidence of CRE is expected to continue to rise during the coming years. What's more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE, such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention is only paid to local complications, there is little report on systemic damage of abdominal or pelvic radiotherapy.
Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is variously known as the "nonthyroidal illness syndrome (NTIS)". This condition is frequently detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid hormone metabolism might change during many chronic illnesses as early as 1973. Data has shown that about 35-70% of acute and chronic critical conditions were associated with a significant abnormal thyroid hormone metabolism, of which LT3S was the most common type. Furthermore, these changes have been shown to be associated with disease severity and have been connected with poor short-term prognosis.
To date, there are lots of literatures include detailed reports on the relationship between LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus, sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRE group | – | Other: Thyroid function testspatients with chronic radiation enteritis |
| malignancy group | – | Other: Thyroid function testspatients with some kinds of malignant tumors but had not previously received radiotherapy |
| control group | – | Other: Thyroid function testsage-matched healthy volunteers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients and volunteers who were admitted to our hospital
Key inclusion criteria (3 listed)
- patients with chronic radiation enteritis
- patients with some kinds of malignant tumors but had not previously received radiotherapy
- age-matched healthy volunteers
Key exclusion criteria (2 listed)
- Patients with a chronic disease other than CRE, including RA, SLE, thyroid illness, infectious diseases, and hepatic or renal disorders were excluded.
- patients have taken any drugs that may influence thyroid hormone secretion and metabolism during the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid function tests | Other | CRE group, control group, malignancy group |
Primary outcome
morbidity
Time frame: one year
The results will be expressed as percentage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of The Clinical Incidence of Low Triiodothyronine Syndrome, run by Shengxian Fan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.