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

Hypothyroidism Clinical Trial

— HYMAQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891668
• Other study ID #: Herlev-Hymaq
• Status: Completed
• Start date: May 2015
• Est. completion date: May 20, 2018

Study information

• Verified date: July 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 20, 2018
• Est. primary completion date: May 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of internal Medicine, Herlev Hospital	Herlev	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in quality of life as measured with the ThyPro questionaire		1 year
Primary	Changes in resting energy expenditure in KCal/day		1 year
Secondary	Changes in Perceived Deficit Questionaire		1 year
Secondary	Changes in insulin resistance evaluated by MATSUDA index		1 year
Secondary	Changes in insulin resistance evaluated by HOMA index		1 year
Secondary	Changes in cognitive tests		1 year
Secondary	Changes in body composition asses through lean mass		1 year
Secondary	Changes in body composition asses through visceral adipose tissue		1 year
Secondary	Changes in body composition asses through fat mass		1 year
Secondary	Changes in free fatty acids		1 year
Secondary	Changes in cholesterol		1 year
Secondary	Changes in serum triglycerides		1 year