| CTRI Number |
CTRI/2026/01/100766 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Early Thyroid Problems and Their Impact on Blood Cholesterol |
|
Scientific Title of Study
|
Assessment of lipid profile in patients of subclinical hypothyroidism |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avtar Singh Dhanju |
| Designation |
Professor |
| Affiliation |
SRI GURU RAM DAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
C/o Swaran Singh , house number 306 ,GREEN FIELD AVENUE MAJIITHA ROAD
Amritsar PUNJAB 143001 India |
| Phone |
7009067238 |
| Fax |
|
| Email |
avtar.dhanju.ad@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Avtar Singh Dhanju |
| Designation |
Professor |
| Affiliation |
SRI GURU RAM DAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
C/o Swaran Singh , 306 GREEN FIELD AVENUE MAJIITHA ROAD, Amritsar , India
Amritsar PUNJAB 143001 India |
| Phone |
7009067238 |
| Fax |
|
| Email |
avtar.dhanju.ad@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mridul soni |
| Designation |
Junior resident |
| Affiliation |
SRI GURU RAM DAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
Sri Guru Ram Das Institute of Medical Sciences,Amritsar , India
Amritsar PUNJAB 143501 India |
| Phone |
7807605775 |
| Fax |
|
| Email |
mridulsoni29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of medicine |
| Address |
SGRD , VALLAH , AMRITSAR |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mridul Soni |
Sri guru ram Das institute of medical sciences and research |
Department of medicine , 3rd floor Amritsar PUNJAB |
7807605775
mridulsoni29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate |
|
| ExclusionCriteria |
| Details |
Pregnancy
Overt hypothyroidism
Patient part of any other study during this period
Familial hypertriglyceridemia
Patient of oral contraceptives |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine if any Relation between sub clinical hypothyroidism and lipid profile,determine if age and sex influence lipid profile in subclinical hypothyrodism |
Determine if any Relation between sub clinical hypothyroidism and lipid profile,determine if age and sex influence lipid profile in subclinical hypothyrodism |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
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)
|
14/01/2026 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subclinical hypothyroidism is a common thyroid disorder characterized by elevated thyroid-stimulating hormone (TSH) levels with normal circulating thyroid hormone levels. Although often asymptomatic, subclinical hypothyroidism has been associated with metabolic disturbances, particularly abnormalities in lipid profile, which may increase the risk of cardiovascular disease.
This cross-sectional observational study aims to assess the lipid profile in adult patients diagnosed with subclinical hypothyroidism and to evaluate the correlation between serum TSH levels and lipid parameters. Adult patients attending the outpatient and inpatient departments of Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, will be screened for subclinical hypothyroidism using thyroid function tests. Eligible participants will undergo lipid profile assessment, including total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, VLDL cholesterol, and non-HDL cholesterol.
The study does not involve any experimental intervention or additional cost to the participants. Blood investigations performed are part of routine clinical evaluation. Written informed consent will be obtained from all participants, and confidentiality of patient data will be strictly maintained. The results of this study may help in early identification of dyslipidemia in patients with subclinical hypothyroidism and emphasize the importance of timely management to reduce future cardiovascular risk. |