Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02891668
Acronym
HYMAQ
Enrollment
42
Registered
2016-09-07
Start date
2015-05-31
Completion date
2018-05-20
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism

Keywords

Basal Metabolic rate, Quality of life, Resting energy expenditure, Insulin resistance, Cognitive Function, 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 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.

Interventions

DRUGLevothyroxine treatment

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

Sponsors

Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in quality of life as measured with the ThyPro questionaire1 year
Changes in resting energy expenditure in KCal/day1 year

Secondary

MeasureTime frame
Changes in serum triglycerides1 year
Changes in Perceived Deficit Questionaire1 year
Changes in insulin resistance evaluated by MATSUDA index1 year
Changes in insulin resistance evaluated by HOMA index1 year
Changes in free fatty acids1 year
Changes in body composition asses through lean mass1 year
Changes in body composition asses through visceral adipose tissue1 year
Changes in body composition asses through fat mass1 year
Changes in cognitive tests1 year
Changes in cholesterol1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026