Clinical trial NCT02891668: Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
Official title: Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Keywords: Basal Metabolic rate
Quality of life
Resting energy expenditure
Insulin resistance
Cognitive Function
Body Composition
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypothyroid patients.

Brief summary: 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).

Detailed description: 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.

* 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.

Eligibility criteria: Inclusion Criteria:

* TSH \> 10 mU/liter

Exclusion Criteria:

* Serious competing illness
* Pregnancy or planning to become pregnant
* Thyroidectomized patients
* Unable to speak and understand danish

Primary outcomes:
measure: Changes in quality of life as measured with the ThyPro questionaire
timeFrame: 1 year
measure: Changes in resting energy expenditure in KCal/day
timeFrame: 1 year
Secondary outcomes:
measure: Changes in Perceived Deficit Questionaire
timeFrame: 1 year
measure: Changes in insulin resistance evaluated by MATSUDA index
timeFrame: 1 year
measure: Changes in insulin resistance evaluated by HOMA index
timeFrame: 1 year
measure: Changes in cognitive tests
timeFrame: 1 year
measure: Changes in body composition asses through lean mass
timeFrame: 1 year
measure: Changes in body composition asses through visceral adipose tissue
timeFrame: 1 year
measure: Changes in body composition asses through fat mass
timeFrame: 1 year
measure: Changes in free fatty acids
timeFrame: 1 year
measure: Changes in cholesterol
timeFrame: 1 year
measure: Changes in serum triglycerides
timeFrame: 1 year
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of internal Medicine, Herlev Hospital
state: Region Hovedstaden
Study officials:
affiliation: Bjarke Medici
name: Bjarke Medici, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.