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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited from NIH Clinical Center, Bethesda, Maryland, USA between June 2005 and November 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
110 participants inquired through phone; 24 screened, 10 excluded 8 did not meet inclusion criteria and 2 refused participation).

Reporting Groups
  Description
Liothyronine First, Then Levothyroxine 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 First, Then Liothyronine 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)

Participant Flow for 3 periods

Period 1:   First Intervention
    Liothyronine First, Then Levothyroxine   Levothyroxine First, Then Liothyronine
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 

Period 2:   Washout Period of 30 Days
    Liothyronine First, Then Levothyroxine   Levothyroxine First, Then Liothyronine
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Liothyronine First, Then Levothyroxine   Levothyroxine First, Then Liothyronine
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects who completed the study

Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive Levothyroxine first and Liothyronine first.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.3  (8.0) 
Gender 
[Units: Participants]
 
Female   13 
Male   1 
Region of Enrollment 
[Units: Participants]
 
United States   14 
Duration of hypothyroidism 
[Units: Years]
Mean (Standard Deviation)
 8.6  (13.1) 
Thyroid stimulating hormone (TSH) 
[Units: mU/liter]
Mean (Standard Deviation)
 1.1  (1.4) 
Triiodothyronine (T3) 
[Units: Ng/dl]
Mean (Standard Deviation)
 99.0  (24.2) 
Free thyroxine (T4) 
[Units: Ng/dl]
Mean (Standard Deviation)
 1.76  (0.46) 


  Outcome Measures

1.  Primary:   Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase   [ Time Frame: One month of therapy. ]

2.  Primary:   Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase   [ Time Frame: One month of therapy ]

3.  Secondary:   Total Cholesterol at Levothyroxine Treatment Phase   [ Time Frame: One month of therapy. ]

4.  Secondary:   Total Cholesterol at Liothyronine Treatment Phase   [ Time Frame: One month of therapy. ]

5.  Secondary:   Triglycerides at Levothyroxine Treatment Phase   [ Time Frame: One month of therapy. ]

6.  Secondary:   Triglycerides at Liothyronine Treatment Phase   [ Time Frame: One month of therapy. ]

7.  Secondary:   Resting Energy Expenditure at Levothyroxine Treatment Phase   [ Time Frame: One month of therapy. ]

8.  Secondary:   Resting Energy Expenditure at Liothyronine Treatment Phase   [ Time Frame: One month of therapy. ]

9.  Secondary:   Left Ventricle Mass Index at Levothyroxine Treatment Phase   [ Time Frame: One month of therapy. ]

10.  Secondary:   Left Ventricle Mass Index at Liothyronine Treatment Phase   [ Time Frame: One month of therapy. ]

11.  Secondary:   Apolipoprotein A-I at Levothyroxine Treatment Phase   [ Time Frame: One month of therapy. ]

12.  Secondary:   Apolipoprotein A-I at Liothyronine Treatment Phase   [ Time Frame: One month of therapy. ]

13.  Secondary:   Apolipoprotein B at Levothyroxine Treatment Phase   [ Time Frame: One month of therapy. ]

14.  Secondary:   Apolipoprotein B at Liothyronine Treatment Phase   [ Time Frame: One month of therapy. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: chenkong@niddk.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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