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The aim of the study is to evaluate the peripheral tissue response to the combined administration of levothyroxine (LT4) and liothyronine (LT3) in hypothyroid patients with residual thyroid function virtually absent (thyroidectomized). Cases will be treated with LT4+LT3, at personalized doses according to clinical guidelines and respecting the circadian rhythmicity of LT3 and the physiological T3/T4 ratio. Controls will be treated with LT4 and placebo. Treatment duration: 24 weeks.
The primary endpoint will be the peripheral effect of thyroid hormones. The secondary endpoints are bone and metabolic modifications, and changes in quality of life. Moreover any changes of outcomes related to polymorphisms of genes involved in thyroid hormones metabolism will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CASES | Experimental | treatment with levothyroxine and liothyronine |
|
| CONTROLS | Active Comparator | treatment with levothyroxine and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liothyronine | Drug | Cases will take liothyronine drops in the morning and two hours after dinner |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L) | change from baseline SHBG serum levels at 12 and 24 weeks (nmol/L) | baseline and then repeated at 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BMI (kg/m2) | body mass index | baseline and then repeated at 6, 12 weeks and 24 weeks |
| quality of life changes | score at validated questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AziendaUSLModena | Modena | 41126 | Italy |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014284 | Triiodothyronine |
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013970 | Thyronines |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Levothyroxin |
| Drug |
Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases) |
|
| Placebos | Drug | Controls will take placebo two hours after dinner |
|
| baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml) | change from baseline TSH serum levels at 12 and 24 weeks (microIU/ml) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L) | change from baseline free triiodothyronine (fT3) serum levels at 12 and 24 weeks (pmol/L) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L) | change from baseline free levothyroxine (fT4) serum levels at 12 and 24 weeks (pmol/L) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl) | change from baseline total cholesterol serum levels at 12 and 24 weeks (mg/dl) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl) | change from baseline HDL cholesterol serum levels at 12 and 24 weeks (mg/dl) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl) | change from baseline triglycerides serum levels at 12 and 24 weeks (mg/dl) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl) | change from baseline C-terminal telopeptide of type 1 collagen at 12 and 24 weeks (ng/dl) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline Osteocalcin at 12 and 24 weeks (ng/mL) | change from baseline Osteocalcin at 12 and 24 weeks (ng/mL) | baseline and then repeated at 12 weeks and 24 weeks |
| change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L) | change from baseline Bone alkaline phosphatase at 12 and 24 weeks (µg/L) | baseline and then repeated at 12 weeks and 24 weeks |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |