Thyroid DiseasesPhase 2NCT00106119

Thyroid and Glucose and Energy Metabolism

A Phase 2 study testing Liothyronine and Levothyroxine in people with Thyroid Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will examine how two thyroid preparations-levothyroxine (T4) and liothyronine (T3)-affect fat and cholesterol metabolism, blood sugar regulation, and thyrotropin secretion in patients who have had their thyroid gland removed. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Thyroid Diseases
What is being tested?: Liothyronine and Levothyroxine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Mar 2005to Nov 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age greater than or equal to 18 years, male or female.
History of total or near total thyroidectomy or hypothyroidism on replacement therapy.
For non-thyroidectomized patients, at least three-year history of replacement therapy (at least 1.2 mcg/Kg LT4/body weight), and less than 5% uptake at 24H on (123)I thyroid scan while on replacement therapy.
Written informed consent.

Who cannot join

BMI less than or equal to 20 or greater than or equal to 30 kg/m(2).
Metastatic thyroid cancer or history of thyroid cancer with high risk of recurrence requiring suppressive thyroid hormone therapy (Singer 1996).
Significant thyroid residual greater than 1 mL as measured by ultrasound (limited to thyroidectomized patients) or greater than 5 percent uptake at 24H on (123)I thyroid scan while on replacement therapy (limited to hypothyroid patients not undergone total thyroidectomy).
History or symptoms compatible with cardiovascular disease, including paroxysmal supraventricular tachycardia, atrial fibrillation, syncopal episodes or use of prescription medications for heart conditions, including antihypertensives.
Allergy to lidocaine, isoproterenol, TRH, levothyroxine, liothyronine, Tylenol #3, oxycodone, nitroglycerin.
Pregnancy or unwillingness to use non-hormonal contraception during the study.

Show all 19Show fewer

Breastfeeding
Use of hormonal contraceptives or estrogen replacement therapy.
Use of tobacco (smoking, chewing) for the two weeks preceding the hospital admissions (metabolic testing)
Diabetes mellitus, either type I or II.
Hypercholesterolemia (serum levels greater than or equal to 240 mg/dL), hypertriglyceridemia (plasma levels greater than or equal to 220 mg/dL) and/or use of antilipemic therapy.
Liver disease or ALT serum level greater than two fold the upper laboratory reference limit.
Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min.
Use of medications/supplements/alternative therapies known to alter thyroid function.
Current history or symptoms compatible with psychosis including 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 5 years; current use of drugs or alcohol (CAGE greater than 3).
Keloid formation (relative to skeletal muscle and subcutaneous adipose tissue biopsies).
Current or previous clinically significant (requiring medical/surgical intervention) extrathyroidal manifestations of autoimmune thyroid disease (dermopathy, ophthalmopathy, arthropathy).

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Peripheral Thyroid Hormone Conversion and Glucose and Energy Metabolism

Patients 18 years of age or older who have had most or all of their thyroid gland removed and are taking long-term thyroid hormone medication may be eligible for this study after screening.

Read the detailed description

Thyroid hormone action plays an important role in the regulation of many physiologic processes, among them glucose and lipid metabolism. Interestingly, the clinical presentation of thyroid dysfunction is extremely variable, with relatively poor correlation between circulating hormone levels and clinical features. This finding suggests that the local, intracellular concentration of the active hormone liothyronine (T3), regulated by peripheral conversion of the pro-hormone levothyroxine (T4), is an important determinant in the maintenance of the thyroidal homeostasis.

The aim of the present study is the evaluation of the role of peripheral thyroid hormone conversion in the regulation of glucose and lipid metabolism by assessing the differential response to T4 or T3 treatment in subjects devoid of endogenous thyroid hormone production. T3 administration bypasses peripheral metabolism and therefore will allow us to assess the role of the peripheral thyroid hormone conversion in the regulation of the hormone action at the end-organ level.

Fifty hypothyroid subjects will be initially randomized to either of the thyroid hormone replacements liothyronine (T3) or levothyroxine (T4) treatment period (one arm cross-over design, with treatment sequence randomized), aimed to maintain serum TSH levels greater than or equal to 0.5 less than or equal to 1.5 mU/L, indicating full replacement. After a 30-day period of steady-state replacement the study subjects will be admitted to the Clinical Center and, after a three-day period of stabilization and an overnight fast, will undergo the following tests: escalating dose TRH stimulation test, indirect calorimetry, graded exercise tolerance test, DEXA scan, and echocardiogram.

Patients will also undergo skeletal muscle biopsy and subcutaneous adipose tissue biopsy and microdialysis, as well as a two-step euglycemic hyperinsulinemic clamp with measurement of splanchnic gluconeogenesis. Fasting venous blood samples will be collected for the determination of the parameters of lipid, glucose and energy metabolism.

After discharge, the patients will switch to the other form of thyroid hormone replacement therapy (second period) . The therapy will be adjusted in order to achieve the same therapeutic goal for TSH concentrations (greater than or equal to 0.5 less than or equal to 1.5 mU/L), analogous to that achieved during the first phase of the study (TSH less than or equal to 0.5 mU/L difference between T3 and T4 phases). After reaching a 30-day period of steady-state replacement, study subjects will be re-admitted to the Clinical Center and the previously described evaluation procedures will be repeated.

Conditions: Thyroid Diseases
Being tested: Liothyronine and Levothyroxine
Keywords: Levothyroxine, Liothyronine, Lipid Metabolism, Gluconeogensis, Thyrotropin Releasing Hormone, Deiodinase, Replacement Thyroid Hormone Therapy, Thyroidectomy, Near Total Thyroidectomy
Medical subject headings: Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liothyronine and LevothyroxineDrug
Also called T3 and T4
Hypothyroid patients are treated with Liothyronine and Levothyroxine in 2 crossover, randomized phases

Study groups in NCT00106119
Study group	Role	What they receive
Liothyronine and Levothyroxine	Active comparator	Hypothyroid patients treatment with Levothyroxine and Liothyronine in 2 crossover, randomized phases Receives: Drug: Liothyronine and Levothyroxine

What is being measured

The primary outcome is the main question the study is designed to answer.

Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase
Measured: One month of therapy.
Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase
Measured: One month of therapy

Secondary outcomes (12)

Total Cholesterol at Levothyroxine Treatment Phase
Measured: One month of therapy.
Total Cholesterol at Liothyronine Treatment Phase
Measured: One month of therapy.
Triglycerides at Levothyroxine Treatment Phase
Measured: One month of therapy.
Triglycerides at Liothyronine Treatment Phase
Measured: One month of therapy.
Resting Energy Expenditure at Levothyroxine Treatment Phase
Measured: One month of therapy.
Resting Energy Expenditure at Liothyronine Treatment Phase
Measured: One month of therapy.
Left Ventricle Mass Index at Levothyroxine Treatment Phase
Measured: One month of therapy.
Left Ventricle Mass Index at Liothyronine Treatment Phase
Measured: One month of therapy.
Apolipoprotein A-I at Levothyroxine Treatment Phase
Measured: One month of therapy.
Apolipoprotein A-I at Liothyronine Treatment Phase
Measured: One month of therapy.
Apolipoprotein B at Levothyroxine Treatment Phase
Measured: One month of therapy.
Apolipoprotein B at Liothyronine Treatment Phase
Measured: One month of therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005Nov 2013

First posted21 Mar 2005 (estimated)
Study startMar 2005
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00106119
Sponsor's protocol ID: 050119
Other IDs: 05-DK-0119
Status last verified: Feb 2015
First submitted: 19 Mar 2005
Last updated: 23 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Arner P, Bolinder J, Wennlund A, Ostman J. Influence of thyroid hormone level on insulin action in human adipose tissue. Diabetes. 1984 Apr;33(4):369-75. doi: 10.2337/diab.33.4.369.
PubMed 6423430
Bakker SJ, ter Maaten JC, Popp-Snijders C, Slaets JP, Heine RJ, Gans RO. The relationship between thyrotropin and low density lipoprotein cholesterol is modified by insulin sensitivity in healthy euthyroid subjects. J Clin Endocrinol Metab. 2001 Mar;86(3):1206-11. doi: 10.1210/jcem.86.3.7324.
PubMed 11238510
Bartha T, Kim SW, Salvatore D, Gereben B, Tu HM, Harney JW, Rudas P, Larsen PR. Characterization of the 5'-flanking and 5'-untranslated regions of the cyclic adenosine 3',5'-monophosphate-responsive human type 2 iodothyronine deiodinase gene. Endocrinology. 2000 Jan;141(1):229-37. doi: 10.1210/endo.141.1.7282.
PubMed 10614643
Yavuz S, Linderman JD, Smith S, Zhao X, Pucino F, Celi FS. The dynamic pituitary response to escalating-dose TRH stimulation test in hypothyroid patients treated with liothyronine or levothyroxine replacement therapy. J Clin Endocrinol Metab. 2013 May;98(5):E862-6. doi: 10.1210/jc.2012-4196. Epub 2013 Apr 12.
PubMed 23585666
Celi FS, Zemskova M, Linderman JD, Smith S, Drinkard B, Sachdev V, Skarulis MC, Kozlosky M, Csako G, Costello R, Pucino F. Metabolic effects of liothyronine therapy in hypothyroidism: a randomized, double-blind, crossover trial of liothyronine versus levothyroxine. J Clin Endocrinol Metab. 2011 Nov;96(11):3466-74. doi: 10.1210/jc.2011-1329. Epub 2011 Aug 24.
PubMed 21865366
Celi FS, Zemskova M, Linderman JD, Babar NI, Skarulis MC, Csako G, Wesley R, Costello R, Penzak SR, Pucino F. The pharmacodynamic equivalence of levothyroxine and liothyronine: a randomized, double blind, cross-over study in thyroidectomized patients. Clin Endocrinol (Oxf). 2010 May;72(5):709-15. doi: 10.1111/j.1365-2265.2009.03700.x.
PubMed 20447070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peripheral Thyroid Hormone Conversion and Glucose and Energy Metabolism
ClinicalTrials.gov ID: NCT00106119
Acronym / sponsor ID: 050119
Conditions: Thyroid Diseases
Keywords: Levothyroxine, Liothyronine, Lipid Metabolism, Gluconeogensis, Thyrotropin Releasing Hormone, Deiodinase, Replacement Thyroid Hormone Therapy, Thyroidectomy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
Study start: Mar 2005
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 21 Mar 2005 (estimated)
Results: Posted 23 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Patients 18 years of age or older who have had most or all of their thyroid gland removed and are taking long-term thyroid hormone medication may be eligible for this study after screening.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 1

Arm	Type	Receives
Liothyronine and Levothyroxine	Active comparator	Drug: Liothyronine and LevothyroxineHypothyroid patients treatment with Levothyroxine and Liothyronine in 2 crossover, randomized phases

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age greater than or equal to 18 years, male or female.
History of total or near total thyroidectomy or hypothyroidism on replacement therapy.
For non-thyroidectomized patients, at least three-year history of replacement therapy (at least 1.2 mcg/Kg LT4/body weight), and less than 5% uptake at 24H on (123)I thyroid scan while on replacement therapy.
Written informed consent.

Key exclusion criteria (19 listed)

BMI less than or equal to 20 or greater than or equal to 30 kg/m(2).
Metastatic thyroid cancer or history of thyroid cancer with high risk of recurrence requiring suppressive thyroid hormone therapy (Singer 1996).
Significant thyroid residual greater than 1 mL as measured by ultrasound (limited to thyroidectomized patients) or greater than 5 percent uptake at 24H on (123)I thyroid scan while on replacement therapy (limited to hypothyroid patients not undergone total thyroidectomy).
History or symptoms compatible with cardiovascular disease, including paroxysmal supraventricular tachycardia, atrial fibrillation, syncopal episodes or use of prescription medications for heart conditions, including antihypertensives.
Allergy to lidocaine, isoproterenol, TRH, levothyroxine, liothyronine, Tylenol #3, oxycodone, nitroglycerin.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liothyronine and LevothyroxineAlso: T3 and T4Hypothyroid patients are treated with Liothyronine and Levothyroxine in 2 crossover, randomized phases	Drug	Liothyronine and Levothyroxine

Primary outcome

Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase
Time frame: One month of therapy.
Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase
Time frame: One month of therapy

12 secondary outcomes

Total Cholesterol at Levothyroxine Treatment Phase
Time frame: One month of therapy.
Total Cholesterol at Liothyronine Treatment Phase
Time frame: One month of therapy.
Triglycerides at Levothyroxine Treatment Phase
Time frame: One month of therapy.
Triglycerides at Liothyronine Treatment Phase
Time frame: One month of therapy.
Resting Energy Expenditure at Levothyroxine Treatment Phase
Time frame: One month of therapy.
Resting Energy Expenditure at Liothyronine Treatment Phase
Time frame: One month of therapy.
Left Ventricle Mass Index at Levothyroxine Treatment Phase
Time frame: One month of therapy.
Left Ventricle Mass Index at Liothyronine Treatment Phase
Time frame: One month of therapy.
Apolipoprotein A-I at Levothyroxine Treatment Phase
Time frame: One month of therapy.
Apolipoprotein A-I at Liothyronine Treatment Phase
Time frame: One month of therapy.
Apolipoprotein B at Levothyroxine Treatment Phase
Time frame: One month of therapy.
Apolipoprotein B at Liothyronine Treatment Phase
Time frame: One month of therapy.

Results and safety

Results posted to the registry on 23 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liothyronine First, Then Levothyroxine	7	7
Levothyroxine First, Then Liothyronine	7	7

Primary outcome: Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase

Time frame: One month of therapy.. Mean (Standard Deviation). Unit: mg/kg/min

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n = 14
Value	7.26 (2.7)

Primary outcome: Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase

Time frame: One month of therapy. Mean (Standard Deviation). Unit: mg/kg/min

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n = 14
Value	7.37 (4.4)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levothyroxine Period	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
Liothyronine Period	0 of 14 (0%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 6423430Arner P, Bolinder J, Wennlund A, Ostman J. Influence of thyroid hormone level on insulin action in human adipose tissue. Diabetes. 1984 Apr;33(4):369-75. doi: 10.2337/diab.33.4.369.
Background: PubMed 11238510Bakker SJ, ter Maaten JC, Popp-Snijders C, Slaets JP, Heine RJ, Gans RO. The relationship between thyrotropin and low density lipoprotein cholesterol is modified by insulin sensitivity in healthy euthyroid subjects. J Clin Endocrinol Metab. 2001 Mar;86(3):1206-11. doi: 10.1210/jcem.86.3.7324.
Background: PubMed 10614643Bartha T, Kim SW, Salvatore D, Gereben B, Tu HM, Harney JW, Rudas P, Larsen PR. Characterization of the 5'-flanking and 5'-untranslated regions of the cyclic adenosine 3',5'-monophosphate-responsive human type 2 iodothyronine deiodinase gene. Endocrinology. 2000 Jan;141(1):229-37. doi: 10.1210/endo.141.1.7282.
Derived from this study: PubMed 23585666Yavuz S, Linderman JD, Smith S, Zhao X, Pucino F, Celi FS. The dynamic pituitary response to escalating-dose TRH stimulation test in hypothyroid patients treated with liothyronine or levothyroxine replacement therapy. J Clin Endocrinol Metab. 2013 May;98(5):E862-6. doi: 10.1210/jc.2012-4196. Epub 2013 Apr 12.
Derived from this study: PubMed 21865366Celi FS, Zemskova M, Linderman JD, Smith S, Drinkard B, Sachdev V, Skarulis MC, Kozlosky M, Csako G, Costello R, Pucino F. Metabolic effects of liothyronine therapy in hypothyroidism: a randomized, double-blind, crossover trial of liothyronine versus levothyroxine. J Clin Endocrinol Metab. 2011 Nov;96(11):3466-74. doi: 10.1210/jc.2011-1329. Epub 2011 Aug 24.
Derived from this study: PubMed 20447070Celi FS, Zemskova M, Linderman JD, Babar NI, Skarulis MC, Csako G, Wesley R, Costello R, Penzak SR, Pucino F. The pharmacodynamic equivalence of levothyroxine and liothyronine: a randomized, double blind, cross-over study in thyroidectomized patients. Clin Endocrinol (Oxf). 2010 May;72(5):709-15. doi: 10.1111/j.1365-2265.2009.03700.x.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.

Related trials for Thyroid Diseases

Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
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Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kong Y Chen, Ph.D. principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liothyronine and Levothyroxine in people with Thyroid Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase (time frame: One month of therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106119, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.