| CTRI Number |
CTRI/2026/01/100122 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Whether Levo Thyroxine treatment can affect hardening of arteries in Type Diabetes Mellitus patients with Sub clinical Hypothyroidism |
|
Scientific Title of Study
|
An open-labelled, randomized controlled study of levothyroxine therapy on arterial stiffness in patients with sub-clinical hypothyroidism and Type 2 diabetes mellitus |
| Trial Acronym |
THYRO-STIFF trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ARINDAM NASKAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
|
| Address |
Room No 16, School of Tropical Medicine
108 CR Avenue
Kolkata
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARINDAM NASKAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
|
| Address |
Room No 16, School of Tropical Medicine
108 CR Avenue
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARINDAM NASKAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
|
| Address |
Room No 16, School of Tropical Medicine
108 CR Avenue
WEST BENGAL
700073
India |
| Phone |
7044007741 |
| Fax |
|
| Email |
indrani.bbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ARINDAM NASKAR |
| Address |
School of Tropical Medicine
108 CR Avenue
Kolkata 700073 |
| Type of Sponsor |
Government 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 |
| Dr Arindam Naskar |
School Of Tropical Medicine |
108 CR Avenue
Kolkata 700073
Kolkata
WEST BENGAL |
7044007741
indrani.bbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee (CREC-STM) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Levo Thyroxine supplementation dose of 25-50 micrograms per day will be given to sub clinical hypothyroid patients |
One group will receive Oral Levo Thyroxine and other group will not be initiated Levo thyroxine in Subclinical hypothyroid patients with Type 2 DM and arterial stiffness will be measured in both groups at baseline and after 6 momths |
| Comparator Agent |
Sublinical Hypothyroid patients with Type 2 DM will not be initiated on oral Levo Thyroxine but their TSH values will be followed up to ensure these patients not develop overt hypothyroidism |
One group will receive Oral Levo Thyroxine and other group will not be initiated Levo thyroxine in Subclinical hypothyroid patients with Type 2 DM and arterial stiffness will be measured in both groups at baseline and after 6 momths |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus, diagnosed with subclinical hypothyroidism (TSH levels are above 4.0 mIU/L but below 10 mIU/L)
Patient giving informed consent |
|
| ExclusionCriteria |
| Details |
Patients who are already on levothyroxine therapy or with previous history of thyroid disorders
Seriously ill patients (known malignancy or patients requiring emergency management)
Patients with serious infective diseases (TB HIV positive Hepatitis B and C positive etc.)
Pregnant and lactating women
Patients on medications like iron calcium proton pump inhibitors amiodarone etc. that can interfere with levothyroxine absorption or have an effect on thyroid profile.
Patients with chronic kidney disease, hepatic and advanced cardiovascular diseases (h/o PTCA AV block)
Patients not willing to participate in the study or provide written informed consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of levothyroxine therapy on arterial stiffness in patients with subclinical hypothyroidism and type 2 diabetes mellitus |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the safety and tolerability of levothyroxine in defined population
To evaluate medication adherence
To observe the effects of levothyroxine on thyroid profile and lipid profile
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Few studies have demonstrated that Pulse Wave Velocity ( PWV) is significantly higher in patients with overt and subclinical Hypothyroidism in comparison to euthyroid patients. However, there is very limited data in existing literature regarding effect of Levothyroxine replacement in arterial stiffness changes in patients with Type 2 Diabetes and Subclinical Hypothyroid . The current study is being undertaken to determine the effects of Levothyroxine on arterial stiffness in patients with Type 2 Diabetes Mellitus and sub clinical hypothyroidism using Oscillometric technique like the Periscope device and parameters like PWV, Aortic Augmentation Index (AIx) and Carotid femoral pulse wave velocity (cf PWV) will be used for assessment. |