Status:
COMPLETED
Pharmacogenomic Response to Thyrotropin-Releasing Hormone Stimulation in Healthy Volunteers: The Influence of a Common Type 2 Deiodinase Genetic Polymorphism on Serum T3
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Thyroid Disease
Healthy
Eligibility:
All Genders
18-65 years
Brief Summary
This study intends to examine how a common genetic pattern affects thyroid function. Recent studies have demonstrated that a substance (enzyme) produced by a gene has an important role in controlling ...
Detailed Description
This study intends to examine how a common genetic pattern affects thyroid function. Recent studies have demonstrated that a substance (enzyme) produced by a gene has an important role in controlling ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects will be healthy male and female adult volunteers, between the ages of 18 and 65, able to provide informed consent. Patients younger than 18 are excluded as this is a purely physiologic study and we are unable to justify any potential risk. However, should our preliminary findings show potential clinically relevant benefits for children, the protocol could be modified to include them. Patients older than 65 are excluded due to intrinsic differences in thyroid hormone dynamics, compared with younger subjects, which could confound study interpretation.
- EXCLUSION CRITERIA:
- BMI less than or equal to 19 or greater than or equal to 35 Kg/m(2)
- Hypothyroidism, or TSH levels above the normal limits (current replacement therapy or TSH greater than 4.0 mcIU/mL)
- Hyperthyroidism, or TSH levels below the normal limits (current or previous therapy or TSH less than 0.4 mcIU/mL)
- Autoimmune thyroid disease (as defined by a positive anti-TPO, or anti-TSH receptor antibody titer)
- Hypertension (Blood pressure greater than 140/90 or use of antihypertensive medication)
- Liver disease or ALT serum concentrations greater than 1.5 times the upper laboratory reference limit.
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (MDRD equation).
- History of, and/or current Diabetes Mellitus (fasting glucose greater than 126 mg/dL)
- Iodine deficiency (spot urine iodine concentration less than 42 mcg/L)
- History of, and/or current coronary artery disease
- History of, and/or current asthma
- History of, and/or current seizures or chronic headache
- History of, and/or current depression
- History of pituitary tumor
- Pregnancy (women of child-bearing potential must have a negative pregnancy test prior to inclusion and at the time of TRH testing)
- Known allergy to TRH
- Current use of prescription medication or certain non-prescription medications and dietary supplements which could affect thyroid function and/or metabolism.
Exclusion
Key Trial Info
Start Date :
December 17 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2014
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00812149
Start Date
December 17 2008
End Date
May 16 2014
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892