| CTRI Number |
CTRI/2023/03/050880 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to see changes in Lipid profile in different subclasses of Hypothyroid patients according to their TSH level. |
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Scientific Title of Study
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"Revaluation of cut off values of TSH based on correlation of biochemical and clinical parameters in Hypothyroid and Biochemically Thyroid patients attending the tertiary care hospital of Bihar-A cross sectional study." |
| Trial Acronym |
|
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanshu Tripathi |
| Designation |
PG Student |
| Affiliation |
AIIMS, PATNA |
| Address |
Admin Building , 3rd Floor, Department Of Biochemistry
AIIMS Patna, Phulwarisharif, Patna, Bihar IPD Building, 4th Floor, Central Lab Biochemistry, AIIMS Patna, Phulwarisharif, Patna, Bihar Patna BIHAR 801507 India |
| Phone |
8318551425 |
| Fax |
|
| Email |
anipri0828@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Ayan Banerjee |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department Of Biochemistry, ADMIN BUILDING, 3rd floor,AIIMS PATNA. Phulwarisharif, Patna , Bihar
Patna BIHAR 801507 India |
| Phone |
9771404616 |
| Fax |
|
| Email |
drayanb@aiimspatna.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Priyanshu Tripathi |
| Designation |
PG Student |
| Affiliation |
AIIMS, PATNA |
| Address |
Admin Building, 3rd Floor, Department Of Biochemistry, AIIMS Patna, Phulwarisharif, Patna, Bihar
IPD Building, 4th Floor, Central Lab Biochemistry, AIIMS Patna, Phulwarisharif, Patna, Bihar Patna BIHAR 801507 India |
| Phone |
8318551425 |
| Fax |
|
| Email |
anipri0828@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA, PHULWARISHARIF , PATNA , BIHAR
PIN CODE- 801507 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PRIYANSHU TRIPATHI |
AIIMS PATNA |
MEDICINE OPD , ROOM NO-413, 1ST FLOOR, DEPARTMENT OF MEDICINE
IPD BUILDING, 4TH FLOOR , D BLOCK, CENTRAL BIOCHEMISTRY LAB, DEPARTMENT OF BIOCHEMISTRY, AIIMS PATNA Patna BIHAR |
8318551425
anipri0828@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS,PATNA- Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient’s age group 18-65 years with non-specific symptoms (untreated) suggestive of hypothyroidism. |
|
| ExclusionCriteria |
| Details |
1. Subjects with previous history of thyroid diseases, such as overt
hyper/hypothyroidism, thyroid
cancer and thyroid nodules.
2. Chronic medical illness or previous surgery pertaining to thyroid.
3. Subjects taking medications affecting thyroid hormone levels such as
thyroid supplementation
and antithyroid agents, and hypolipidemic agents like statins, oral
contraceptive pills.
4. Pregnancy.
5. Diabetes Mellitus.
|
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the level of correlation of cut off values of TSH in relation to dyslipidaemia, hsCRP, anti TPO and anti TG in Hypothyroid, Sub clinical Hypothyroid and two Groups of Biochemically euthyroid patients.
2.To revaluate the cut off values of TSH based on the association of biochemical parameters observed.
|
As Observational Study so from the time of recruitment ( 0 months) till the study period allocated i.e. July 2024, patients will be tested for the above parameters and results will be analysed without follow up. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To access the association of signs and symptoms suggestive of hypothyroidism using the ZULEWSKI score. |
As Observational Study so from the time of recruitment ( 0 months) till the study period allocated i.e. July 2024, patients will be tested for the above parameters and results will be analysed without follow up. |
|
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Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Hypothyroidism is one amongst the most mainstream endocrine disorders worldwide. The prevalence of hypothyroidism in India is 10-11%. The recent studies reflect the significant burden of over 42 million population in INDIA alone suffering from thyroid disease. Hypothyroidism is a common cause of secondary dyslipidaemia and subsequent cardiovascular risk. These patients exhibit significantly high serum total Cholesterol, LDL-C and Triglyceride. Studies done in patients of subclinical hypothyroidism (SCH) have shown a similar picture though less pronounced. Studies in the past have shown serum TSH above 1.5 or 2 mIU/L (Biochemically euthyroid- BET) linked with increased hypothyroid associated lipid and inflammatory pathologies thus increasing the morbidity and mortality. Subclinical hypothyroidism (SCH) suggests mild thyroid failure with raised TSH in combination with serum free T3 and T4 within normal reference range. The prevalence of SCH is 4-15% depending on the population under study. SCH is more rampant than frank hypothyroidism. Moreover, the conversion rate of SCH with positive TPO antibody is around 6% per year, hence early screening and diagnosis of the concerned populations is the prime need of the hour to prevent further elevation in serum TSH and the clinical implications that follows. The most common cause of SCH is autoimmune thyroiditis with raised anti-TPO abs. Controversially high biochemically euthyroid (high BET) subjects with serum TSH>3.01-<5.0 mIU/L were found to have high anti-TPO ab titres and higher rates of progression to overt hypothyroidism in spite of TSH being within normal cut offs. Thus, the core of the debate is to trail down the upper limit of TSH reference range. The aim of the present study is to see if biochemically euthyroid, subclinical hypothyroid and overt hypothyroid differ significantly with respect to their lipid profile, anti-TPO, anti-TG, hsCRP levels in conjugation with TSH ranges. And if yes, the addition of above tests for early diagnosis and prompt initiation of thyroid hormone replacement in such patients could possibly save extra expenditures on long-term diseases and it’s attending morbidities. Study design: A Hospital based cross-sectional study. An informed consent would be taken from all the participants of this study after they have been briefed about information pertaining to this study. The study population will be recruited from the Dept. of Medicine, AIIMS, Patna. The study will be carried out in the Dept. of Biochemistry, AIIMS, Patna. Data shall be collected from untreated patients of age group 18-65 years, presenting to the hospital with non-specific symptoms suggestive of hypothyroidism. They would be advised thyroid and lipid profile, hsCRP, anti-TPO, anti-TG apart from routine filling of questionnaires. The study group will be classified as HT(HYPOTHYROID), SCH and BET ( BIOCHEMICALLY EUTHYROID)based on the thyroid profile. After data collection , the results will be statistically analysed.
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