Hypothyroidism, Metabolism and Food Intake
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Observational

Summary: 
      This project has the following primary aims:

      To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during
      the first six months after starting levothyroxine (L-T4) substitution therapy

      Secondary aims are:

      To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body
      mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut
      and pancreatic hormone responses, gastric and gall bladder emptying, resting energy
      expenditure (REE), quality of life (QOL) and cognitive function
    

Detailed description: 
      18 newly diagnosed hypothyroid female patients and 18 healthy controls 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.

      The study is devided in to three identical experimental days of approx. 6 hours. First
      experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid
      Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day
      after 6 months of T4 therapy.

      For 5-7 days before each experimental day, the participants' physical activity energy
      expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the
      chest.

      The last two days before each experimental day, the participants will follow a standardised
      diet following World Health Organization guidelines on energy requirements and nutrient
      composition according to gender, age and body weight Shortly after diagnosis patients will
      undergo a test panel at the first experimental day, where patients arrives fasting.

      Visual analog score on satiety and thirst will be filled out continuously. REE will be
      measured by a CCM-express calorimeter,

        -  Dual Energy X-ray absorptiometry (DEXA)-scan

        -  Blood samples will be taken continuously during the experimental day. Gall bladder size
           will be examined at 6 times during the experimental day using ultra sound.

      At the end of the day, patients´ satiety will be examined with an ad libitum meal.

      Blood will be analysed for Gastric inhibitory polypeptide (GIP), Glucagon-like Peptide 1
      (GLP-1), Glucagon-like Peptide 2 (GLP-2), glucagon, peptide tyrosine tyrosine (PYY), Gastrin,
      Cholesystokinin (CCK), Insulin, C-peptide, Blood sugar, Cholesterol, Free fatty acids and
      paracetamol.
    

Intervention name(s): Levothyroxine
Intervention type(s): Drug
Intervention description(s): Normal treatment with levothyroxine.
Other intervention name(s): Eltroxin/Euthyrox
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18 Hypothyroid female patients with a TSH > 10 without Levothyroxine treatment.
      
Biospecimen description: 
      Blood Urine
    
Keywords: Food intake; Resting Energy Expenditure; Gall Bladder emptying; Insulin response; Body Composition