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

ID: NCT02891668
Status: Active, not recruiting
Phase: N/A
Start Date: May 01, 2015
First Submitted: May 17, 2016
Last Updated: February 23, 2018
Results: N/A
Organization: Herlev Hospital
Sponsors & Collaborators: Herlev Hospital
Location: Denmark
Conditions: Hypothyroidism
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for 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).

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.
Condition or disease Intervention/treatment Phase

Hypothyroidism

Drug: Levothyroxine treatment
Other Names
Eltroxin, Euthyrox
N/A

Tracking Information

First Submitted DateMay 17, 2016
Last Update Posted DateFebruary 23, 2018
Start DateMay 01, 2015
Anticipated Completion DateMay 01, 2018
Primary Completion DateMay 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Changes in quality of life as measured with the ThyPro questionaire [Time Frame: 1 year]

  • Changes in resting energy expenditure in KCal/day [Time Frame: 1 year]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Changes in Perceived Deficit Questionaire [Time Frame: 1 year]

  • Changes in insulin resistance evaluated by MATSUDA index [Time Frame: 1 year]

  • Changes in insulin resistance evaluated by HOMA index [Time Frame: 1 year]

  • Changes in cognitive tests [Time Frame: 1 year]

  • Changes in body composition asses through lean mass [Time Frame: 1 year]

  • Changes in body composition asses through visceral adipose tissue [Time Frame: 1 year]

  • Changes in body composition asses through fat mass [Time Frame: 1 year]

  • Changes in free fatty acids [Time Frame: 1 year]

  • Changes in cholesterol [Time Frame: 1 year]

  • Changes in serum triglycerides [Time Frame: 1 year]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleHypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition
Official TitleHypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and 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.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
42
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Hypothyroidism
Target Follow-Up Duration N/A
Biospecimen:
Retention: Samples Without DNA
Description: Blood
Sampling MethodNon-Probability Sample
Study PopulationHypothyroid patients.
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.

Other Names
Eltroxin, Euthyrox
Study Groups/Cohorts
Hypothyroid
Levothyroxine treatment

Healthy volunteers
Matched on age and BMI 18 persons

Study Arms
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.

Arm Intervention/Treatment
Hypothyroid
Levothyroxine treatment
Drug : Levothyroxine treatment

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment42
Completion DateMay 01, 2018
Eligibility 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
GenderAll
Age20 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Denmark

Administrative Information

NCT Number:NCT02891668
Other Study ID Numbers
Herlev-Hymaq
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyBjarke Borregaard Medici, Herlev Hospital
Study Sponsor
Herlev Hospital
Collaborators
Not Available
Investigators
Principal Investigator
Bjarke Medici, MD
Bjarke Medici