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Will there be any change in kidney function in Subclinical Hypothyroid patients with diabetes after initiating Levothyroxine

Effect of Levothyroxine replacement on changes in renal function in Subclinical Hypothyroid Patients with Type 2 Diabetes: an Open Label, Randomized Controlled Pilot Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089606
Enrollment
56
Registered
2025-06-26
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: Levo thyroxine Tablet: Levothyroxine tablet will be given to Subclinical Hypothyroid patients to look for any effect on renal function Intervention2: Intervention: oral Levothyroxine su

Sponsors

ARINDAM NASKAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 65 years Patients who give informed consent

Exclusion criteria

Exclusion criteria: Pregnant and lactating Type 1 DM heart failure (NYHA III AND IV) Atrial fibrillation Chronic liver disease ( child pugh C) Patients on levothyroxine therapy or anti-thyroid medications Patients on any medications that can affect thyroid hormone function eg amiodarone or lithium Diagnosed case of thyroid malignancies BMI greater than 40kg/m2 Thyroid surgeries

Design outcomes

Primary

MeasureTime frame
To assess the change in eGFR among diabetic patients with Subclincal Hypothyroidism following Levothyroxine therapyTimepoint: 6 months

Secondary

MeasureTime frame
1)Proportion of patients with sustained decline in the estimated GFR of at least 50% 2) Proportion of patients developing End Stage Renal Disease (ESRD) Any changes in :- 3) Urine albumin-creatinine ratio 4) Lipid profile 5) AST, ALT 6) Uric acidTimepoint: 6 months

Countries

India

Contacts

Public ContactARINDAM NASKAR

School of Tropical Medicine

indrani.bbs@gmail.com7044007741

Outcome results

None listed

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