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Thyroid and Glucose and Energy Metabolism

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ClinicalTrials.gov Identifier: NCT00106119
Recruitment Status : Completed
First Posted : March 21, 2005
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Kong Chen, Ph.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator)
Condition Thyroid Diseases
Intervention Drug: Liothyronine and Levothyroxine
Enrollment 18
Recruitment Details Participants recruited from NIH Clinical Center, Bethesda, Maryland, USA between June 2005 and November 2007.
Pre-assignment Details 110 participants inquired through phone; 24 screened, 10 excluded 8 did not meet inclusion criteria and 2 refused participation).
Arm/Group Title Liothyronine First, Then Levothyroxine Levothyroxine First, Then Liothyronine
Hide Arm/Group Description Liothyronine (dose of 2.5, 10, or 16 mcg) in first intervention period and Levothyroxine (dose of 5, 10, or 33 mcg) in second intervention period (after washout period) Levothyroxine (dose of 5, 10, or 33 mcg) in first intervention period and Liothyronine (dose of 2.5, 10, or 16 mcg) in second intervention period (after washout period)
Period Title: First Intervention
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Washout Period of 30 Days
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Second Intervention
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive Levothyroxine first and Liothyronine first.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Subjects who completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
49.3  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
13
  92.9%
Male
1
   7.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Duration of hypothyroidism  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
8.6  (13.1)
Thyroid stimulating hormone (TSH)  
Mean (Standard Deviation)
Unit of measure:  mU/liter
Number Analyzed 14 participants
1.1  (1.4)
Triiodothyronine (T3)  
Mean (Standard Deviation)
Unit of measure:  Ng/dl
Number Analyzed 14 participants
99.0  (24.2)
Free thyroxine (T4)  
Mean (Standard Deviation)
Unit of measure:  Ng/dl
Number Analyzed 14 participants
1.76  (0.46)
1.Primary Outcome
Title Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
7.26  (2.7)
2.Primary Outcome
Title Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
7.37  (4.4)
3.Secondary Outcome
Title Total Cholesterol at Levothyroxine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
196  (26)
4.Secondary Outcome
Title Total Cholesterol at Liothyronine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
174  (28)
5.Secondary Outcome
Title Triglycerides at Levothyroxine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
152  (31)
6.Secondary Outcome
Title Triglycerides at Liothyronine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
144  (16)
7.Secondary Outcome
Title Resting Energy Expenditure at Levothyroxine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: kcal/24 hour
1201  (282)
8.Secondary Outcome
Title Resting Energy Expenditure at Liothyronine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention ArmArm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: kcal/24 hour
1177  (323)
9.Secondary Outcome
Title Left Ventricle Mass Index at Levothyroxine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: g/m^2
71  (16)
10.Secondary Outcome
Title Left Ventricle Mass Index at Liothyronine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: g/m^2
71  (19)
11.Secondary Outcome
Title Apolipoprotein A-I at Levothyroxine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
152  (31)
12.Secondary Outcome
Title Apolipoprotein A-I at Liothyronine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
144  (16)
13.Secondary Outcome
Title Apolipoprotein B at Levothyroxine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
87  (19)
14.Secondary Outcome
Title Apolipoprotein B at Liothyronine Treatment Phase
Hide Description [Not Specified]
Time Frame One month of therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liothyronine/Levothyroxine Therapy Intervention Arm
Hide Arm/Group Description:
Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mg/dl
72  (15)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levothyroxine Period Liothyronine Period
Hide Arm/Group Description Patients at Levothyroxine Period Patients at Liothyronine Period
All-Cause Mortality
Levothyroxine Period Liothyronine Period
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levothyroxine Period Liothyronine Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
General disorders     
General disorders   0/14 (0.00%)  0 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levothyroxine Period Liothyronine Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/14 (0.00%)    
Psychiatric disorders     
generalized anxiety disorder * [1]  1/14 (7.14%)  14 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
This adverse event could not be separated between two treatment periods.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kong Chen
Organization: National Institute of Diabetes and Digestive and Kidney Diseases
Phone: 3014511636
Responsible Party: Kong Chen, Ph.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00106119     History of Changes
Other Study ID Numbers: 050119
05-DK-0119 ( Other Identifier: NIH )
First Submitted: March 19, 2005
First Posted: March 21, 2005
Results First Submitted: November 12, 2014
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015