Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02317926
Status:
UNKNOWN
Last Update Posted:
2015-05-06
First Post:
2014-12-08
Brief Title:
Desiccated Thyroid Extract Versus Synthetic T3T4 Combination ThyrolarTM Versus L-T4 Alone in the Therapy of Primary Hypothyroidism With Special Attention to the Gene Polymorphism
Sponsor:
Walter Reed National Military Medical Center
Organization:
Walter Reed National Military Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study design is a prospective randomized double-blind crossover study After informed consent is obtained patients will be randomized to receive either desiccated thyroid in capsules or L-T4L-T3 ThyrolarTM in capsules or L-T4 alone capsules All study participants physician investigators those administering the neurocognitive tests and those analyzing test results will be blinded throughout the study
Subjects will undergo memory testing a disease specific symptom questionnaire a general mental health assessment a complete physical examination baseline EKG and biochemical testing consisting of serum TSH free T4 total T4 total T3 free T3 T3 resin uptake reverse T3 sex hormone binding globulin SHBG serum iodine a lipid panel insulin glucose and leptin This testing and DXA scan of body composition will be performed at baseline and after each 3 month treatment period Deiodinase type 2 DIO2 polymorphisms analyses - will also be performed at the beginning of the study and the results will be blinded to the investigators performing the memory testing
After 5-6 weeks on the study medication TSH levels will be checked and the medication adjusted to maintain TSH level between 046-468 mIUL Once the TSH level is in the desired range subjects will continue the medication for an additional 6 weeks Subjects will then be crossed-over to the other treatment arm for 3 months Again testing will be performed after each treatment period Finally the subjects will again switched over to the 3rd arm and testing will be performed after treatment period
A cross-over design is preferred because we are assessing subjective symptoms such as clinical well-being and other parameters Therefore we will be able to evaluate the effectiveness of L-T4T3 ThyrolarTM vs DTE vs T4 alone in the same patientssubjects This is also supported by the previous study by Escobar-Morreale et al
Additionally the Wechsler memory scale DEXA for body composition measurment of reverse T3 insulin leptin and DIO2 polymorphisms analysis will be included for the research portion of this study Further the frequency of serum blood draws for research purposes will be at intervals of 0 6 12 18 24 30 and 36 weeks
Subjects will undergo memory testing a disease specific symptom questionnaire a general mental health assessment a complete physical examination baseline EKG and biochemical testing consisting of serum TSH free T4 total T4 total T3 free T3 T3 resin uptake reverse T3 sex hormone binding globulin SHBG serum iodine a lipid panel insulin glucose and leptin This testing and DXA scan of body composition will be performed at baseline and after each 3 month treatment period Deiodinase type 2 DIO2 polymorphisms analyses - will also be performed at the beginning of the study and the results will be blinded to the investigators performing the memory testing
After 5-6 weeks on the study medication TSH levels will be checked and the medication adjusted to maintain TSH level between 046-468 mIUL Once the TSH level is in the desired range subjects will continue the medication for an additional 6 weeks Subjects will then be crossed-over to the other treatment arm for 3 months Again testing will be performed after each treatment period Finally the subjects will again switched over to the 3rd arm and testing will be performed after treatment period
A cross-over design is preferred because we are assessing subjective symptoms such as clinical well-being and other parameters Therefore we will be able to evaluate the effectiveness of L-T4T3 ThyrolarTM vs DTE vs T4 alone in the same patientssubjects This is also supported by the previous study by Escobar-Morreale et al
Additionally the Wechsler memory scale DEXA for body composition measurment of reverse T3 insulin leptin and DIO2 polymorphisms analysis will be included for the research portion of this study Further the frequency of serum blood draws for research purposes will be at intervals of 0 6 12 18 24 30 and 36 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None