| CTRI Number |
CTRI/2025/05/086699 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lipid profile in euthyroidism and hypothyroidism and comparing them
|
|
Scientific Title of Study
|
Comparative Assessment of Lipid Profile in Euthyroidism and Hypothyroidism: A cross- sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrikant Badiger |
| Designation |
Student |
| Affiliation |
KLEs JNMC |
| Address |
Department of Biochemistry
KLEs JNMC Belagavi
Department of Biochemistry
KLEs JNMC Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844014755 |
| Fax |
|
| Email |
shreebadigar48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangamma Sajjan |
| Designation |
Assistant Professor |
| Affiliation |
Department of Biochemistry KLEs JNMC Belagavi 590001 karanataka |
| Address |
Department of Biochemistry
KLEs JNMC Belagavi
Department of Biochemistry
KLEs JNMC Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9980872468 |
| Fax |
|
| Email |
7jyothigs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangamma Sajjan |
| Designation |
Assistant Professor |
| Affiliation |
Department of Biochemistry KLEs JNMC Belagavi 590001 karanataka |
| Address |
Department of Biochemistry
KLEs JNMC Belagavi
Department of Biochemistry
KLEs JNMC Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9980872468 |
| Fax |
|
| Email |
7jyothigs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shrikant Badiger |
| Address |
Department of Biochemistry
KLEs JNMC Belagavi 590001
karanataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Sangamma Sajjan |
KLEs Prabhakar Kore Hospital and MRC |
OPD No 1 Endocrinology
Ground Floor
Belgaum
KARNATAKA |
9980872468
7jyothigs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Any adult subject between the age group 18-60 years irrespective of gender
Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Pregnant women
History of heart surgery or other cardiovascular interventions
Chronic kidney disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lipid profile is altered in hypothyroid patients compared to euthyroid patients |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
20/05/2025 |
| 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="0"
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
|
Previous studies have shown that the
lipid profile in people with hypothyroidism varies between individuals and
across different countries. However, there is a lack of regional data,
particularly from specific geographical areas. The
present study is designed to determine the pattern of lipid profile in
hypothyroid patients specifically in the North Karnataka region. This researrch focus will help provide
more relevant and localized data to better understand the relationship between
thyroid dysfunction and lipid profiles in this population.
|