NCT01441154

Brief Summary

Background: \- Thyroid hormone is produced by the thyroid gland, an organ at the base of the neck. Thyroid hormone controls the body's metabolism and the function of many organs. The thyroid gland produces two forms of thyroid hormone: T4 and T3. People who have thyroid cancer are treated with thyroid hormone therapy (synthetic T4, levothyroxine), which at times needs to be stopped to allow for cancer treatments. At these times, a different form of thyroid hormone (synthetic T3, liothyronine) is used to reduce the symptoms caused by low levels of thyroid hormone. Researchers want to know more about how changes in T3 hormone affect the body and organ function. Objectives: \- To study how changes in T3 hormone levels affect the body and organ function. Eligibility: \- Individuals at least 18 years of age who have had most or all of their thyroid removed to treat thyroid cancer who need to stop taking their regular thyroid hormone dose in preparation for the treatment of thyroid cancer. Design:

  • The study involves a screening visit and a baseline evaluation. It also includes an 11-day inpatient hospital stay.
  • Participants will be screened with a physical exam and medical history. They will also have blood tests and a neck ultrasound.
  • Participants will be evaluated with a physical exam, blood tests, and the following procedures:
  • Glucose tolerance test to measure blood sugar
  • Tests of body fat, muscle strength, and calorie burning levels
  • Imaging studies of the heart, liver, and thigh muscles
  • Quality of life questionnaires
  • Food preference and diet questionnaires
  • After 4 weeks of treatment with T3 hormone, participants will have an 11-day inpatient hospital stay to study the effect of thyroid hormone on their metabolism. The stay will involve the same tests done in the baseline evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2013

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

September 24, 2011

Last Update Submit

September 25, 2020

Conditions

Malignant Struma OvariiPapillary Thyroid CancerHurthle Cell Thyroid CancerFollicular Thyroid CancerTall Cell Variant Thyroid Cancer

Keywords

HypothyroidismThyroid CancerTriiodothyronine (T3)Energy ExpenditureThyroid Hormone

Outcome Measures

Primary Outcomes (3)

  • 1. To assess the pharmacokinetics of T3 in patients devoid of endogenous or exogenous T4 during acute L-T3 withdrawal at steady- state and after the first L-T3 dose administration

    to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer

    4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment

  • 2. To estimate the minimal duration of L-T3 therapy withdrawal required to achieve a serum TSH level, equal or greater than 30 uIU/mL, to assure effective 131I therapy for treatment of differentiated thyroid cancer

    to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer

    4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment

  • 3. To correlate clinical and biochemical parameters of thyroid hormone action, with circulating levels of T3 during L-T3 therapy withdrawal

    to study T3 kinetics in thyroidectomized patients treated with liothyronine (L- T3) replacement therapy in preparation for diagnostic or therapeutic nuclear medicine procedures for the follow-up and management of differentiated thyroid cancer

    4 weeks after stopping L-T4 thyroid hormone replacement therapy and starting L-T3 treatment

Study Arms (1)

Group 1

Adults with clinical indication for withdrawal from thyroid hormone replacement therapy in preparation for nuclear medicine imaging or therapeutic procedures with radioactive iodine

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary clinical

You may qualify if:

  • Subjects will be adult volunteers older than age 18 who underwent total thyroidectomy for the treatment of differentiated thyroid cancer, previously undergone radioactive iodine ablation of the thyroid gland remnant, with clinical indication for withdrawal from thyroid hormone replacement therapy in preparation for nuclear medicine imaging or therapeutic procedures with radioactive iodine. The patient population will be recruited from the participants in the 77-DK-0096 natural history protocol: Studies on Thyroid Nodules and Thyroid Cancer , PI Dr.Joanna Klubo-Gwiezdzinska and from the 10-C-0102 natural history protocol: Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer , PI Electron Kebebew.

You may not qualify if:

  • Significant thyroid residual greater than 5 gm as measure by ultrasound or greater than 5 percent uptake at 24 H on (123) I pre-treatment thyroid scan.
  • Renal insufficiency or estimated creatinine clearance less than or equal to 60 mL/min/1.73M(2) BSA by MDRD equation before thyroid hormone withdrawal.
  • Liver disease or ALT \>2.5 times the upper laboratory reference limit.
  • Pharmacologic therapy for the treatment of psychiatric conditions.
  • History of, and/or current coronary artery disease.
  • Current history or symptoms compatible with psychosis or major depression (including history of hospitalization for depression, history of attempted suicide, history of suicidal ideation). Use of antipsychotic medications.
  • History of drug or alcohol abuse within the last year; current use of illicit drugs or alcohol abuse (CAGE\>3).
  • Known allergy to L-T3.
  • Current use of prescription medication or certain non-prescription medications and dietary supplements known to affect thyroid function and/or metabolism, or alter the pharmacokinetics of L-T3.
  • Inability or unwillingness to follow the low-iodine, metabolic diet or non-compliance to the L-T3 administration regimen.
  • The presence of persistent diarrhea or malabsorption syndromes that would interfere with the patient s ability to adequately absorb drugs.
  • Inability to obtain venous access for sample collection, or basal hemoglobin of less than or equal to 10 g/dL.
  • Low functional status (ECOG Performance Status \> 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Yen PM. Physiological and molecular basis of thyroid hormone action. Physiol Rev. 2001 Jul;81(3):1097-142. doi: 10.1152/physrev.2001.81.3.1097.

    PMID: 11427693BACKGROUND

  • Bianco AC, Salvatore D, Gereben B, Berry MJ, Larsen PR. Biochemistry, cellular and molecular biology, and physiological roles of the iodothyronine selenodeiodinases. Endocr Rev. 2002 Feb;23(1):38-89. doi: 10.1210/edrv.23.1.0455.

    PMID: 11844744BACKGROUND

  • Nguyen TT, DiStefano JJ 3rd, Yamada H, Yen YM. Steady state organ distribution and metabolism of thyroxine and 3,5,3'-triiodothyronine in intestines, liver, kidneys, blood, and residual carcass of the rat in vivo. Endocrinology. 1993 Dec;133(6):2973-83. doi: 10.1210/endo.133.6.8243325.

    PMID: 8243325BACKGROUND

Related Links

MeSH Terms

Conditions

Thyroid Cancer, PapillaryThyroid cancer, Hurthle cellAdenocarcinoma, FollicularHypothyroidismThyroid Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Kong Y Chen, Ph.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2011

First Posted

September 27, 2011

Study Start

September 20, 2011

Primary Completion

December 12, 2013

Study Completion

December 12, 2013

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations

US(1)