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

Sponsor
Herlev Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02891668
Collaborator
(none)
42
Enrollment
1
Location
36.6
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Levothyroxine 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 Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
May 20, 2018
Actual Study Completion Date :
May 20, 2018

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

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

    2. Changes in resting energy expenditure in KCal/day [1 year]

    Secondary Outcome Measures

    1. Changes in Perceived Deficit Questionaire [1 year]

    2. Changes in insulin resistance evaluated by MATSUDA index [1 year]

    3. Changes in insulin resistance evaluated by HOMA index [1 year]

    4. Changes in cognitive tests [1 year]

    5. Changes in body composition asses through lean mass [1 year]

    6. Changes in body composition asses through visceral adipose tissue [1 year]

    7. Changes in body composition asses through fat mass [1 year]

    8. Changes in free fatty acids [1 year]

    9. Changes in cholesterol [1 year]

    10. Changes in serum triglycerides [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of internal Medicine, Herlev Hospital Herlev Region Hovedstaden Denmark DK-2730

    Sponsors and Collaborators

    • Herlev Hospital

    Investigators

    • Principal Investigator: Bjarke Medici, MD, Bjarke Medici

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bjarke Borregaard Medici, MD, PH.d. student, Herlev Hospital
    ClinicalTrials.gov Identifier:
    NCT02891668
    Other Study ID Numbers:
    • Herlev-Hymaq
    First Posted:
    Sep 7, 2016
    Last Update Posted:
    Aug 1, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Bjarke Borregaard Medici, MD, PH.d. student, Herlev Hospital
    Basal Metabolic rate
    Quality of life
    Resting energy expenditure
    Insulin resistance
    Cognitive Function
    Body Composition
    Additional relevant MeSH terms:
    Hypothyroidism

    Study Results

    No Results Posted as of Aug 1, 2018