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Completed

NCT Number: NCT02891668

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

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).

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of internal Medicine, Herlev Hospital

Herlev, Capital Region, DK-2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levothyroxine treatment

Drug

Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.

Other names: Eltroxin, Euthyrox

Primary outcomes

  1. Changes in quality of life as measured with the ThyPro questionaire

    Time frame: 1 year

  2. Changes in resting energy expenditure in KCal/day

    Time frame: 1 year

Secondary outcomes

  1. Changes in Perceived Deficit Questionaire

    Time frame: 1 year

  2. Changes in insulin resistance evaluated by MATSUDA index

    Time frame: 1 year

  3. Changes in insulin resistance evaluated by HOMA index

    Time frame: 1 year

  4. Changes in cognitive tests

    Time frame: 1 year

  5. Changes in body composition asses through lean mass

    Time frame: 1 year

  6. Changes in body composition asses through visceral adipose tissue

    Time frame: 1 year

  7. Changes in body composition asses through fat mass

    Time frame: 1 year

  8. Changes in free fatty acids

    Time frame: 1 year

  9. Changes in cholesterol

    Time frame: 1 year

  10. Changes in serum triglycerides

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Acronym: HYMAQ

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2016
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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