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| ID | Type | Description | Link |
|---|---|---|---|
| K24AG042765-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid hormone levels, is a common diagnosis in the elderly. The purpose of this study is to examine the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older with persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition, participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits: baseline and while taking two different thyroid hormone preparations, levothyroxine and liothyronine. The investigators will also assess physiologic responses to these two different thyroid hormone medications to help us understand how the thyroid works in advanced age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine First | Experimental | Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine |
|
| Liothyronine First | Experimental | Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine | Drug | Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| TSH Area Under the Curve | TSH area under the curve within 60 minutes of TRH stimulation when TSH is at goal | 0, 5, 10, 15, 20, 30, and 60 min post TRH |
| TSH Max | The maximum concentration of TSH after TRH stimulation when TSH is at goal | Between 0 and 180 min after TRH stimulation |
| Free T4 Level | Free thyroxine level when TSH level is at goal on therapy. | An average of 7 months after initiating therapy |
| Total T3 Level | Total triiodothyronine level when TSH is at goal on therapy | An average of 7 months |
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Inclusion Criteria:
Exclusion Criteria:
Laboratory Tests:
Surgeries or Procedures:
Medical Conditions:
Medications:
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| Name | Affiliation | Role |
|---|---|---|
| Anne R Cappola, MD, ScM | The University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levothyroxine First | Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment). |
| FG001 | Liothyronine First | Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levothyroxine First | Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TSH Area Under the Curve | TSH area under the curve within 60 minutes of TRH stimulation when TSH is at goal | Posted | Mean | Standard Deviation | μIU*min/mL | 0, 5, 10, 15, 20, 30, and 60 min post TRH |
|
|
Through study completion, an average of 7 months in each arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levothyroxine | While taking levothyroxine | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Cappola | University of Pennsylvania | 2155375359 | acappola@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 | Jan 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D014284 | Triiodothyronine |
| D013973 | Thyrotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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|
| Liothyronine | Drug | Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L |
|
|
| Thyrotropin-Releasing Hormone | Drug | 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment). |
|
| BG001 | Liothyronine First | Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | TSH Max | The maximum concentration of TSH after TRH stimulation when TSH is at goal | Posted | Mean | Standard Deviation | mIU/L | Between 0 and 180 min after TRH stimulation |
|
|
|
| Primary | Free T4 Level | Free thyroxine level when TSH level is at goal on therapy. | Posted | Mean | Standard Deviation | ng/dL | An average of 7 months after initiating therapy |
|
|
|
| Primary | Total T3 Level | Total triiodothyronine level when TSH is at goal on therapy | Posted | Mean | Standard Deviation | ng/mL | An average of 7 months |
|
|
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Liothyronine | While taking liothyronine | 0 | 13 | 0 | 13 | 0 | 13 |
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| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013970 | Thyronines |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |