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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 
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. 
Scientific Title of Study   "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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
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  
 
Source of Monetary or Material Support  
AIIMS PATNA 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS,PATNA- Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E038||Other specified hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
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.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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. 
 
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. 
 
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 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 rangeThe 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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