Department of internal Medicine, Herlev Hospital
Herlev, Capital Region, DK-2730, Denmark
NCT Number: NCT02891668
This project has the following primary aims:
The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment.
Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).
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Notify Me20 year–75 year
All sexes
Observational
Herlev, Capital Region, DK-2730, Denmark
Subjects and Methods:
74 newly diagnosed hypothyroid patients of both genders and age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy. Participants will get an appointment immediately after diagnosis to avoid unnecessary delay of treatment. Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.
After 6 and 12 months of treatment patients will undergo a similar experimental day and return to their general practitioner or outpatient clinic.
A control group of 18 matched healthy persons will undergo the first experimental day in the same way as the hypothyroid patients, except they do not start any kind of therapy and they only participate in the first experimental day.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.
Other names: Eltroxin, Euthyrox
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Herlev Hospital
Other
Acronym: HYMAQ
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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