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Effect of levothyroxine therapy on albuminuria and glomerular function in patients with type 2 diabetes and subclinical Hypothyroidism: a randomized controlled pilot trial.

Arindam Naskar·Agnibho Mondal·Alex George·Shekhar Pal·Indranil Dhar
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Abstract

AIMS: To evaluate the effect of levothyroxine therapy on renal outcomes in patients with type 2 diabetes mellitus (T2DM) and subclinical hypothyroidism (SCH) with background SGLT2 inhibitor therapy. METHODS: In this hypothesis generating open-label, randomized controlled pilot trial, adults with T2DM and SCH were assigned (1:1) to levothyroxine or no levothyroxine therapy and followed for 6&#xa0;months. Primary outcomes were changes in urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR). RESULTS: Sixty participants were randomized (30 per group); 24 and 27 completed follow-up in the treatment and control groups respectively. UACR decreased with levothyroxine (-13.09&#xa0;mg/g) and increased in controls (31.84&#xa0;mg/g). The difference was significant in per-protocol (PP)(-44.93&#xa0;mg/g; 95% CI -77.6 to -12.26; p&#xa0;=&#xa0;0.008) but insignificant in intention to treat (ITT)(-35.61&#xa0;mg/g; 95% CI -77.31 to 6.08; p&#xa0;=&#xa0;0.092). eGFR changes were statistically insignificant in both ITT(4.65&#xa0;mL/min/1.73&#xa0;m2; 95% CI -8.3 to 17.6; p&#xa0;=&#xa0;0.472) and PP(7.35&#xa0;mL/min/1.73&#xa0;m2; 95% CI -1.68 to 16.37; p&#xa0;=&#xa0;0.108). Thyroid-stimulating hormone decreased significantly in treatment arm in comparison to control arm (p&#xa0;<&#xa0;0.001) in ITT and PP. No adverse event was reported. CONCLUSIONS: Levothyroxine treatment showed trend toward improving albuminuria and eGFR without reaching statistical significance, suggesting possible renoprotective effect warranting further studies. CLINICAL TRIAL REGISTRATION: This trial is registered with Clinical Trial Registry of India (CTRI/2025/06/089606).

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HumansDiabetes Mellitus, Type 2HypothyroidismAlbuminuriaThyroxineFemalePilot ProjectsMaleMiddle AgedGlomerular Filtration RateAgedAdultDiabetic NephropathiesEstimated Glomerular Filtration RateLevothyroxine TherapyRenal FunctionSub Clinical HypothyroidismType 2 Diabetes MellitusUrinary Albumin Creatinine RatioJournal ArticleRandomized Controlled Trial

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Arindam Naskar, Agnibho Mondal, Alex George, Shekhar Pal, Indranil Dhar. 2026-08-06. Effect of levothyroxine therapy on albuminuria and glomerular function in patients with type 2 diabetes and subclinical Hypothyroidism: a randomized controlled pilot trial.. https://doi.org/10.1016/j.diabres.2026.113487

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Journal Article; Randomized Controlled Trial resourceAdult subjectAged subjectDiabetes Mellitus, Type 2 subjectDiabetic Nephropathies subjectEstimated glomerular filtration rate subjectFemale subjectGlomerular Filtration Rate subjectHumans subjectJournal Article subjectMale subjectMiddle Aged subjectPilot Projects subjectRandomized controlled trials study

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