Clinical trial · Interventional
Energy Metabolism in Thyroidectomized Patients
NCT04782856CI-TRIAL-00077967completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to measure the changes in energy metabolism (how the body burns energy), cardiovascular function (heart function), and lipid metabolism (cholesterol break down and building) before and after thyroidectomy (surgical removal of thyroid gland) in response to two approved therapies for hypothyroidism: levothyroxine (LT4) or Liothyronine/levothyroxine (LT3/LT4) combination therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypothyroidism | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Goiter | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levothyroxine | Drug | — | UNRESOLVED |
| Liothyronine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Single therapy
- description
- Levothyroxine (LT4) and placebo (a look-alike inactive substance, a "sugar pill") Patients in the LT4 group will be started at a dose of 1.6 mcg/Kg (52 The VCU Investigational Pharmacy will over-encapsulate LT4 plus placebo, in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation.
- interventionNames
- Drug: Levothyroxine
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Combination therapy
- description
- Liothyronine/levothyroxine (LT3/LT4) combination therapy. LT4/LT3 group will have 25 mcg of LT4 substituted with 5 mcg LT3 twice daily, to mimic the average daily T3 production form the thyroid The VCU Investigational Pharmacy will over-encapsulate LT4 plus 5 mcg LT3 in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation. No changes will be made in LT3.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical indication for total thyroidectomy 2. TSH at screening \>0.045\<4.5mlU/m 3. Adult men and women Age ≥18-89 years of age 4. Euthyroid patients with clinical indication for total thyroidectomy 5. Indication to total thyroidectomy for benign goiter or thyroid cancer not requiring suppressive thyroid hormone therapy Exclusion Criteria: 1. Weight \<50 or \>150 Kg 2. Graves' disease 3. Use of thyroid hormone therapy or thyroid supplements (at screening) except for multinodular goiter 4. Indication for thyroid hormone suppressive therapy following surgery 5. Uncontrolled arterial hypertension stage 2 or greater (\>140/90 mm Hg at screening) while on medication (patients with hypertension controlled by therapy will be allowed to participate). 6. Uncontrolled diabetes (HbA1c \> 8.% at screening or Fructosamine \> 325 mmol/L) 7. History of cardiovascular disease, congestive heart failure or unstable coronary artery disease (angina, coronary event, or revascularization within 6 months); atrial fibrillation; or ventricular arrhythmia, 8. History of major depression or psychosis 9. Patients who are Pregnant, breastfeeding planned pregnancy within six months from the thyroidectomy 10. Any conditions that in the opinion of the PI may impede the successful completion of the study
References
Publications (0)
Data not yet available
No reference posted for this study.