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

July 31, 2018 updated by: Bjarke Borregaard Medici, Herlev Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Hovedstaden
      • Herlev, Region Hovedstaden, Denmark, DK-2730
        • Department of internal Medicine, Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hypothyroid patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypothyroid
Levothyroxine treatment
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.
Other Names:
  • Eltroxin, Euthyrox
Healthy volunteers
Matched on age and BMI 18 persons

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Bjarke Medici, MD, Bjarke Medici

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 20, 2018

Study Completion (Actual)

May 20, 2018

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Herlev-Hymaq

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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