Clinical Trial: Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition

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 Summary:

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 wi
Sponsor: Herlev Hospital

Current Primary Outcome:

  • Changes in quality of life as measured with the ThyPro questionaire [ Time Frame: 1 year ]
  • Changes in resting energy expenditure in KCal/day [ Time Frame: 1 year ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Perceived Deficit Questionaire [ Time Frame: 1 year ]
  • Changes in insulin resistance evaluated by MATSUDA index [ Time Frame: 1 year ]
  • Changes in insulin resistance evaluated by HOMA index [ Time Frame: 1 year ]
  • Changes in cognitive tests [ Time Frame: 1 year ]
  • Changes in body composition asses through lean mass [ Time Frame: 1 year ]
  • Changes in body composition asses through visceral adipose tissue [ Time Frame: 1 year ]
  • Changes in body composition asses through fat mass [ Time Frame: 1 year ]
  • Changes in free fatty acids [ Time Frame: 1 year ]
  • Changes in cholesterol [ Time Frame: 1 year ]
  • Changes in serum triglycerides [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Herlev Hospital

Dates:
Date Received: May 17, 2016
Date Started: May 2015
Date Completion: May 2018
Last Updated: September 1, 2016
Last Verified: September 2016