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Energy Metabolism in Thyroidectomized Patients

Phase 2
Waitlist Available
Led By Francesco S Celi, MD, MHSc
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months

Summary

This trial compares two treatments for patients who have had their thyroid gland removed. One treatment uses Levothyroxine alone, and the other uses a combination of Levothyroxine and Liothyronine. These treatments replace essential hormones to help the body function normally. Some patients prefer the combination therapy despite mixed results.

Eligible Conditions
  • Hypothyroidism
  • Thyroid Cancer
  • Thyroid Goiter

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Cholesterol
Energy Expenditure (EE)
Short Term Change in Weight
Other study objectives
Change in Quality of Life

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT04288115
5%
Gangrene of toe
5%
catheter ablation of arrhythmogenic focus
5%
revision posterior decompression cervical cord and fusion
5%
transurethral prostatectomy
5%
diarrhea
5%
angina pectoris
5%
fall
5%
fluoroscopy guided percutaneous insertion of drug eluting stent into coronary artery with contrast
5%
hypertensive disorder
5%
low blood pressure
5%
bronchitis
5%
intravitreal injection of anti-vascular endothelial growth factor
5%
carcinoma of prostate
5%
paresthesia of upper limb
5%
restenosis
5%
scalp itchy
5%
shoulder pain
5%
simple extraction of tooth
5%
spasm
5%
polyp of transverse colon
5%
polyp of sigmoid colon
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group ("Real Discontinuation")
Levothyroxine Group ("Sham Discontinuation")

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Combination therapyExperimental Treatment2 Interventions
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.
Group II: Single therapyActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liothyronine
2015
Completed Phase 3
~310
Levothyroxine
2013
Completed Phase 4
~3840

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,095 Total Patients Enrolled
4 Trials studying Hypothyroidism
2,856 Patients Enrolled for Hypothyroidism
Virginia Commonwealth UniversityLead Sponsor
717 Previous Clinical Trials
22,895,685 Total Patients Enrolled
Francesco S Celi, MD, MHScPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
3 Total Patients Enrolled
Angeliki M Stamatouli, MDPrincipal InvestigatorVirginia Commonwealth University

Media Library

Levothyroxine Clinical Trial Eligibility Overview. Trial Name: NCT04782856 — Phase 2
Hypothyroidism Research Study Groups: Combination therapy, Single therapy
Hypothyroidism Clinical Trial 2023: Levothyroxine Highlights & Side Effects. Trial Name: NCT04782856 — Phase 2
Levothyroxine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782856 — Phase 2
~3 spots leftby Dec 2025
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