Whether replacing thyroid hormones in sub clinical hypothyroid patients with Type 2 Diabetes can affect various insulin resistance markers

Effects of Levothyroxine replacement therapy on insulin resistance markers in patients with subclinical hypothyroidism with Type 2 Diabetes: An open label, randomized, controlled pilot trial - THYRO-IR trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100144

Enrollment

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: E08-E13- Diabetes mellitus Health Condition 2: E02- Subclinical iodine-deficiency hypothyroidism

Interventions

Intervention1: Oral Levo Thyroxine supplementation dose of 25-50 micrograms per day will be given to sub clinical hypothyroid patients: Type 2 DM patients with Sub clinical hypothyroidism, one group

Eligibility

Inclusion criteria

Inclusion criteria: Patients who give informed consent

Exclusion criteria

Exclusion criteria: Pregnant and lactating women Type 1 diabetes mellitus Heart failure (NYHA III AND IV) Atrial fibrillation Chronic liver disease (Child Pugh C) CKD (eGFR less than 30 by CKD EPI) Patients on Levothyroxine therapy or anti-thyroid medications Patients on medications that can affect thyroid hormone function e.g. Amiodarone or Lithium Diagnosed case of thyroid malignancies BMI more than 40kg/m2 Previous Thyroid surgeries

Design outcomes

Primary

Measure	Time frame
To evaluate whether levothyroxine therapy improve markers of Insulin resistance among patients with diabetes and subclinical hypothyroidism.Timepoint: 6 Months	—

Secondary

Measure	Time frame
To compare any change from baseline to week 24 in Lipid Profile BMI eGFR Urinary albumin creatinine ratio ALT and ASTTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDR ARINDAM NASKAR

School of Tropical Medicine

indrani.bbs@gmail.com7044007741

Outcome results

None listed

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