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Whether Levo Thyroxine treatment can affect hardening of arteries in Type Diabetes Mellitus patients with Sub clinical Hypothyroidism

An open-labelled, randomized controlled study of levothyroxine therapy on arterial stiffness in patients with sub-clinical hypothyroidism and Type 2 diabetes mellitus - THYRO-STIFF trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100122
Enrollment
56
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: 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

Sponsors

DR ARINDAM NASKAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To study the efficacy of levothyroxine therapy on arterial stiffness in patients with subclinical hypothyroidism and type 2 diabetes mellitusTimepoint: 6 months

Secondary

MeasureTime frame
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 Timepoint: 6 months

Countries

India

Contacts

Public ContactDR ARINDAM NASKAR
indrani.bbs@gmail.com7044007741

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026