Health Condition 1: E02- Subclinical iodine-deficiency hypothyroidism Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| To study the efficacy of levothyroxine therapy on arterial stiffness in patients with subclinical hypothyroidism and type 2 diabetes mellitusTimepoint: 6 months | — |
Secondary
| Measure | Time 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