Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04795947 |
Other study ID # |
2021-PRO39-Hypothyroidism |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 1, 2020 |
Est. completion date |
November 1, 2021 |
Study information
Verified date |
March 2021 |
Source |
Beijing Chao Yang Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
According to the prevalence survey of thyroid diseases in ten cities in China in 2010,
TSH>4.2 mIU /L was the diagnostic cut-off point, and the prevalence of hypothyroidism was
17.8%, including 1.1% clinical hypothyroidism.The annual incidence of hypothyroidism in China
is 2.9‰, and primary hypothyroidism is the most common.Typical patients have chilliness,
fatigue, swelling of hands and feet, lethargy, memory loss, hypoperspiration, joint pain,
weight gain, constipation, menstrual disorder or menorrhagia, infertility, which affects the
physiological and psychological functions of patients and reduces the quality of life of
patients.The treatment goal of primary clinical hypothyroidism is that the symptoms and signs
of hypothyroidism disappear, and TSH, TT4 and FT4 values remain in the normal
range.Levothyroxine (L-T4) is the main alternative therapy for this disease.Thyroid disease
patients quality of life questionnaire (Thyroid - specific Patient Reported Outcome, ThyPRO)
for the development of the Danish scholars such as WATT first can be applied to various
comprehensive scale of benign Thyroid disease patients, applied in the Danish people has good
reliability and validity, has been translated into ten languages application in many
countries the crowd, WATT et al in 2015 developed the scale of the concise version
(ThyPRO39).Studies have shown that in the treatment of patients with thyroid disease, even if
thyroid function is within the normal range, there are still physiological or psychological
impairments such as chills, fatigue, anxiety, depression, which reduces the quality of life
of patients.Studies have shown that TSH level in patients with hypothyroidism is correlated
with patients' quality of life. Even within the normal range, the higher TSH level is, the
worse the patients' quality of life score is, and there is an independent correlation in
fatigue and emotional susceptibility.
This study except for other factors, such as merger disease with primary hypothyroidism
patients quality of life assessment, observe the normal JiaJian patients, we use the current
widely used thyroid disease patients to evaluate the quality of life questionnaire (ThyPRO -
39), observe thyroid hormone levels in patients with hypothyroidism and their quality of life
scale and the relevance of the blood sugar, blood lipid metabolic indicators related to
relevance.
Description:
Hypothyroidism is a systemic metabolic syndrome caused by reduced thyroid hormone production
and secretion or reduced tissue function.According to the prevalence survey of thyroid
diseases in ten cities in China in 2010, TSH>4.2 mIU /L was the diagnostic cut-off point, and
the prevalence of hypothyroidism was 17.8%, of which the prevalence of subclinical
hypothyroidism was 16.7%, and the prevalence of clinical hypothyroidism was 1.1% [6].The
prevalence was higher in females than in males and increased with age.The annual incidence of
hypothyroidism in China is 2.9‰[7].Epidemiological evidence suggests that hypothyroidism is
associated with anxiety and mood disorders [4].Several studies have shown that hypothyroidism
is associated with lower quality of life (QOL), higher load symptom, poorer physical and
mental health, and poorer attention performance.The treatment goal of primary clinical
hypothyroidism is that the symptoms and signs of hypothyroidism disappear, and TSH, TT4 and
FT4 values remain in the normal range.Levothyroxine (L-T4) is the main alternative therapy
for this disease [8].Thypro questionnaire (Thypro) is the first comprehensive scale developed
by Danish scholar Watt et al., which is applicable to patients with various benign Thyroid
diseases. It has been translated into 10 languages and applied in populations in many
countries.[9].Studies have shown that, in the treatment of hypothyroidism patients, even if
thyroid function is in the normal range, there are still chills, fatigue, anxiety, depression
and other physiological or psychological damage, reducing the quality of life of patients.The
relationship between thyroid hormone levels and quality of life in patients with treated
hypothyroidism is controversial.Studies have shown that in patients with primary
hypothyroidism, higher TSH values are associated with impaired quality of life, even if TSH
is within the normal reference range.TSH was positively correlated with the scores of fatigue
and emotional susceptibility scales, indicating that these two aspects of quality of life
were significantly affected with the increase of TSH level [1].However, some studies have
shown that the quality of life of hypothyroidism patients treated with levothyroxine has
nothing to do with the level of thyroid hormone, and TSH or free T4 cannot be used as the
indicator of the best treatment effect, because it cannot reflect the patient's quality of
life [2].But in the study, a significant percentage of patients with hypothyroidism
simultaneously with high blood pressure, diabetes, dyslipidemia, diseases such as depression
or anxiety, long-term use may affect the metabolism of thyroid hormones and drugs, and
combined with the disease itself also has effect on the quality of life in patients with [2],
not real thyroid hormone levels in patients with quality of life, their metabolism and the
influence of correlation, etc.
This study except for other factors, such as merger disease with primary hypothyroidism
patients quality of life assessment, observe the normal JiaJian patients, we use the current
widely used thyroid disease patients to evaluate the quality of life questionnaire (ThyPRO -
39), observe JiaJian thyroid hormone levels in patients with son and their quality of life
scale and the relevance of the blood sugar, blood lipid metabolic indicators related to
relevance.
Signed in patients voluntary and informed consent, to assess all criteria of patients,
collected demographic data (such as gender, age, etc.), record the history and the other
previous medical history, family history, related to the vital signs data (such as height,
weight, waist circumference, hip circumference, BMI and waist hip ratio, blood pressure),
laboratory indexes (including thyroid function, HbA1c, fasting insulin, fasting C peptide,
blood biochemistry), thyroid ultrasound.Patients meeting the inclusion criteria received two
questionnaires: ThyPRO-39 (Chinese version), and the MOS 36-item Short Form Health Survey
(SF36).ThyPRO39 has 39 items, 12 subscale tables and 1 single item to evaluate overall
quality of life.The 12 subscales were further divided into 3 categories: (1) somatic symptoms
(goiter symptoms, hyperthyroidism symptoms, hypothyroidism symptoms, thyroid ophthalmopathy
symptoms);(2) physiological (fatigue, cognition), psychological (anxiety, depression, mood)
and social (social activities, daily life);(3) the appearance.This scale is a self-rating
scale, and Likert 5-grade score is used to calculate the crude score of each subscale, and
then the control scoresheet and calculation formula are converted into standard score. The
total score of standard score ranges from 0 to 100, and the higher the score, the worse the
quality of life [3].SF36 is a commonly used universal scale for the study of quality of life
in patients with thyroid disease, which measures 8 health concepts and 1 self-rating of
health changes.Eight of these health concepts are further divided into two categories, namely
physical health and mental health.SF36 is a multi-item scale, each dimension contains 2 ~ 10
items, including a total of 36 items.The total score of SF36 is 100 points, and the higher
the score, the better the health status [5].The purpose of this study was to evaluate the
relationship between thyroid function and health-related quality of life (HRQOL) and related
metabolic indicators in patients with hypothyroidism.