| CTRI Number |
CTRI/2025/02/079907 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Lipid profile in subclinical and overt hypothyroidism |
|
Scientific Title of Study
|
Study of lipid profile in subclinical and overt 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 |
Sachin Rathod |
| Designation |
Junior Resident |
| Affiliation |
Department of General Medicine Dr DY Patil Medical College. |
| Address |
Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706 India
Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706 India
Thane
MAHARASHTRA
400706
India |
| Phone |
9658674444 |
| Fax |
|
| Email |
drsachingrathod10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Pendse |
| Designation |
Professor |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706 India
Thane
MAHARASHTRA
400706
India |
| Phone |
9320051082 |
| Fax |
|
| Email |
drmanishpendse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachin Rathod |
| Designation |
Junior Resident |
| Affiliation |
Dr DY Patil Medical College, Navi Mumbai |
| Address |
Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706 India
Thane
MAHARASHTRA
400706
India |
| Phone |
9658674444 |
| Fax |
|
| Email |
drsachingrathod10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine Dr DY Patil Medical College, Navi Mumbai
Thane
MAHARASHTRA
400706 India |
|
|
Primary Sponsor
|
| Name |
Sachin Rathod |
| Address |
Junior Resident Department of General Medicine Dr DY Patil Medical College, Navi Mumbai-400706 |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 |
| Sachin Rathod |
Dr. D.Y. Patil Hospital |
OPD 1, OPD 2, OPD 3, OPD 4(General Medicine OPD) Dr. D.Y. Patil Hospital Nerul, Navi Mumbai-400706 Thane MAHARASHTRA
Thane
MAHARASHTRA |
9658674444
drsachingrathod10@gmil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research, Dr DY Patil Medical College, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
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 |
Newly diagnosed cases of primary hypothyroidism. |
|
| ExclusionCriteria |
| Details |
1) Patient not consenting to enroll in the study.
2) Patients with other comorbid illnesses which can affect lipid profile status.
Diabetes Mellitus Type 2
Patient on antidyslipidemic treatment
Patient on antipsychotic treatment
Patient on prolonged steroids
Patient on Oral contraceptive Pills |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the type of dyslipidemia in patients with subclinical and overt hypothyroidism |
To study the type of dyslipidemia in patients with subclinical and overt hypothyroidism |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and interpret the type of dyslipidemia in the two. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/02/2025 |
| 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 Yet Recruiting |
| 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
|
A lipid profile in hypothyroidism typically shows alterations due to reduced metabolism caused by thyroid hormone deficiency. The main findings include: Elevated Total Cholesterol: Due to decreased clearance of low-density lipoprotein (LDL) cholesterol. 1. Increased LDL Cholesterol: Caused by reduced activity of LDL receptors. 3. Increased Triglycerides: More common in subclinical hypothyroidism. 4. Reduced HDL Cholesterol (occasionally): Can occur in overt hypothyroidism but is less consistent. 5. Atherogenic Dyslipidemia: Increased risk of atherosclerosis due to the pro-atherogenic lipid profile.
These changes increase the risk of cardiovascular diseases in hypothyroid patients. Lipid abnormalities typically improve with appropriate thyroid hormone replacement therapy. |