Health Condition 1: E00-E07- Disorders of thyroid gland
Conditions
Interventions
Intervention1: Levothyroxine: Starting dose 25 mcg/day, doses titrated every 8+/-2 weeks to achieve euthyroidism and doses that achieved euthyroidism maintained for 20-26 weeks
Control Intervention1:
Sponsors
All India Institute of Medical Sciences, Bhopal
Indian Thyroid Society
Eligibility
Inclusion criteria
Inclusion criteria: Subclininical hypothyroidism with serum TSH 4.21-10 uIU/ml , normal serum total T4 (5.1-14.1 ug/dl) and normal serum free T4 (0.92-1.68 ng/dl) with any one of the following: 1.Anti TPO antibody positive 2.Firm thyroid on palpation and FNAC features suggestive of autoimmune thyroiditis 3.Thyroglobulin antibody positive
Exclusion criteria
Exclusion criteria: 1.Refusal to give consent for participation 2.Pregnancy 3.Planning pregnancy in next 6 months 4.History of coronary artery disease, heart failure (LVEF less than 50 percent), or atrial fibrillation 5. Chronic liver disease (viral hepatitis B/C), autoimmune liver disease, or significant alcohol intake (more than 20 g/day women, more than 30 g/day men) 6.Uncontrolled diabetes mellitus (HbA1C more than or equal to 7 percent) 7. Obesity class II (BMI more than or equal to 30 kg per m2) 8. Renal insufficiency (eGFR less than 60 ml per minute)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare effect of levothyroxine on controlled attenuation parameter (CAP) at baseline and after attaining euthyroidism. 2.To compare effect of levothyroxine on left ventricular(LV) diastolic function, left ventricular(LV) systolic function and right ventricular(RV) systolic function assessed by 2D Echocardiography at baseline and after attaining euthyroidism.LV diastolic function-E/A, E/e dash.LV systolic function- LVEF, LV global longitudinal strain (GLS). RV systolic function- Tricuspid annular plane systolic excursion, RV S dash velocity, RV FAC, RV free wall strain.Timepoint: Baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare effect of LT4 on liver stiffness measurement (LSM) at baseline and after attaining euthyroidism. 2.To compare effect of LT4 on left atrial strain parameters at baseline and after attaining euthyroidism.LA strain parameters- LASr, LAScd,LASct 3.To analyse the correlation between the decrease in TSH and the reduction in hepatic steatosis at baseline and after attaining euthyroidism 4.To analyse the correlation between decrease in TSH and improvement in cardiac function parameters at baseline and after attaining euthyroidism 5.To evaluate changes in metabolic parameters (serum cholesterol, serum triglycerides, LDL cholesterol,HDL cholesterol) and liver enzymes (AST,ALT) at baseline and after attaining euthyroidism 6.To compare Insulin resistance at baseline and after attaining euthyroidism.Timepoint: Baseline and 6 months | — |
Countries
India
Contacts
Public ContactDr Pragya Karki
All India Institute of Medical Sciences, Bhopal
Outcome results
None listed