Trial Outcomes & Findings for Thyroid and Glucose and Energy Metabolism (NCT NCT00106119)

NCT ID: NCT00106119

Last Updated: 2015-02-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: One month of therapy.
• Results posted on: 2015-02-23

Participant Flow

Participants recruited from NIH Clinical Center, Bethesda, Maryland, USA between June 2005 and November 2007.

110 participants inquired through phone; 24 screened, 10 excluded 8 did not meet inclusion criteria and 2 refused participation).

Participant milestones

Measure	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)
First Intervention STARTED	7	7
First Intervention COMPLETED	7	7
First Intervention NOT COMPLETED	0	0
Washout Period of 30 Days STARTED	7	7
Washout Period of 30 Days COMPLETED	7	7
Washout Period of 30 Days NOT COMPLETED	0	0
Second Intervention STARTED	7	7
Second Intervention COMPLETED	7	7
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thyroid and Glucose and Energy Metabolism

Baseline characteristics by cohort

Measure	Entire Study Population n=14 Participants Includes groups randomized to receive Levothyroxine first and Liothyronine first.
Age, Continuous	49.3 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Duration of hypothyroidism	8.6 years STANDARD_DEVIATION 13.1 • n=5 Participants
Thyroid stimulating hormone (TSH)	1.1 mU/liter STANDARD_DEVIATION 1.4 • n=5 Participants
Triiodothyronine (T3)	99.0 ng/dl STANDARD_DEVIATION 24.2 • n=5 Participants
Free thyroxine (T4)	1.76 ng/dl STANDARD_DEVIATION 0.46 • n=5 Participants

PRIMARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase	7.26 mg/kg/min Standard Deviation 2.7

PRIMARY outcome

Timeframe: One month of therapy

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase	7.37 mg/kg/min Standard Deviation 4.4

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Total Cholesterol at Levothyroxine Treatment Phase	196 mg/dl Standard Deviation 26

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Total Cholesterol at Liothyronine Treatment Phase	174 mg/dl Standard Deviation 28

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Triglycerides at Levothyroxine Treatment Phase	152 mg/dl Standard Deviation 31

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Triglycerides at Liothyronine Treatment Phase	144 mg/dl Standard Deviation 16

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Resting Energy Expenditure at Levothyroxine Treatment Phase	1201 kcal/24 hour Standard Deviation 282

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Resting Energy Expenditure at Liothyronine Treatment Phase	1177 kcal/24 hour Standard Deviation 323

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Left Ventricle Mass Index at Levothyroxine Treatment Phase	71 g/m^2 Standard Deviation 16

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Left Ventricle Mass Index at Liothyronine Treatment Phase	71 g/m^2 Standard Deviation 19

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Apolipoprotein A-I at Levothyroxine Treatment Phase	152 mg/dl Standard Deviation 31

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Apolipoprotein A-I at Liothyronine Treatment Phase	144 mg/dl Standard Deviation 16

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Apolipoprotein B at Levothyroxine Treatment Phase	87 mg/dl Standard Deviation 19

SECONDARY outcome

Timeframe: One month of therapy.

Outcome measures

Measure	Liothyronine/Levothyroxine Therapy Intervention Arm n=14 Participants Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
Apolipoprotein B at Liothyronine Treatment Phase	72 mg/dl Standard Deviation 15

Adverse Events

Levothyroxine Period

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Liothyronine Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Levothyroxine Period n=14 participants at risk Patients at Levothyroxine Period	Liothyronine Period n=14 participants at risk Patients at Liothyronine Period
General disorders General disorders	0.00% 0/14 • 6 weeks	0.00% 0/14 • 6 weeks

Other adverse events

Measure	Levothyroxine Period n=14 participants at risk Patients at Levothyroxine Period	Liothyronine Period n=14 participants at risk Patients at Liothyronine Period
Psychiatric disorders generalized anxiety disorder	7.1% 1/14 • Number of events 14 • 6 weeks	0.00% 0/14 • 6 weeks

Additional Information

Dr. Kong Chen

National Institute of Diabetes and Digestive and Kidney Diseases

Phone: 3014511636

Email: chenkong@niddk.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place