Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Observational

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.
    

Intervention name(s): Levothyroxine treatment
Intervention type(s): Drug
Intervention description(s): Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.
Other intervention name(s): Eltroxin, Euthyrox
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hypothyroid patients.
      
Biospecimen description: 
      Blood
    
Keywords: Basal Metabolic rate; Quality of life; Resting energy expenditure; Insulin resistance; Cognitive Function; Body Composition