Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
NCT ID: NCT02891668
Last Updated: 2018-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2015-05-31
2018-05-20
Brief Summary
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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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Detailed Description
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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.
* Psychological test using:
* ThyPRO a thyroid-specific quality of life questionnaire(18),
* Cognitive function by CALCAP® Abbreviated Test Battery,
* Perceived cognitive deficit questionnaire (Perceived Deficits Questionaire)
* Major Depression Inventory (MDI) questionnaire
* REE will be measured by a CCM-express calorimeter,
* DEXA-scan
* Blood samples will be taken and patients will be characterized through basic information.
* Insulin resistance will be assess through an oral glucose tolerance test (OGTT) At end of the first experimental day patients will start L-T4 therapy following national guidelines, with regular control of thyroid hormones to ensure optimal treatment. When patients are euthyroid and TSH is below 4 \* 10-3 International Units pr liter (mU/l) patients will have blood samples monitored every 3 months for the rest of the trial.
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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hypothyroid
Levothyroxine treatment
Levothyroxine treatment
Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.
Healthy volunteers
Matched on age and BMI 18 persons
No interventions assigned to this group
Interventions
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Levothyroxine treatment
Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy or planning to become pregnant
* Thyroidectomized patients
* Unable to speak and understand danish
20 Years
75 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Bjarke Borregaard Medici
MD, PH.d. student
Principal Investigators
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Bjarke Medici, MD
Role: PRINCIPAL_INVESTIGATOR
Bjarke Medici
Locations
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Department of internal Medicine, Herlev Hospital
Herlev, Capital Region, Denmark
Countries
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References
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Medici BB, Lerche la Cour J, Knop FK, Krakauer M, Michaelsson LF, Faber J, Watt T, Nygaard B. Predictors of Improvement in Quality of Life When Treating Hypothyroidism. J Thyroid Res. 2021 Jun 11;2021:5577217. doi: 10.1155/2021/5577217. eCollection 2021.
Other Identifiers
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Herlev-Hymaq
Identifier Type: -
Identifier Source: org_study_id
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