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

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ClinicalTrials.gov Identifier: NCT02891668
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Bjarke Borregaard Medici, Herlev Hospital

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
Hypothyroidism 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.

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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 2015
Actual Primary Completion Date : May 20, 2018
Actual Study Completion Date : May 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

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 Name: Eltroxin, Euthyrox

Healthy volunteers
Matched on age and BMI 18 persons



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypothyroid patients.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891668


Locations
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Denmark
Department of internal Medicine, Herlev Hospital
Herlev, Region Hovedstaden, Denmark, DK-2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Bjarke Medici, MD Bjarke Medici
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Responsible Party: Bjarke Borregaard Medici, MD, PH.d. student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02891668    
Other Study ID Numbers: Herlev-Hymaq
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bjarke Borregaard Medici, Herlev Hospital:
Basal Metabolic rate
Quality of life
Resting energy expenditure
Insulin resistance
Cognitive Function
Body Composition
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases