ThyrOp: A Study of Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter (ThyrOp)

April 24, 2012 updated by: Tina Toft Kristensen, Naestved Hospital

ThyrOp: Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter - Focus on Weight Gain and Mitochondrial Dysfunction

The hypothesis of the study is that among patients that do not develop overt hypothyroidism after hemithyroidectomy, weight gain is a clinical manifestation of a postoperatively lowered set point of thyroid function - even if the thyroid function is lowered within the laboratory reference range. The investigators refer to this hypothesized condition as individual subclinical hypothyroidism.

Thyroid hormones are major regulators of mitochondrial function and subclinical hypothyroidism affects mitochondrial activity. The aim of the study is to examine if a lowered set point of thyroid function after hemithyroidectomy can be measured in the mitochondrial function, the body weight and the basal oxygen consumption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The operation of hemithyroidectomy (total thyroid lobectomy and isthmusectomy with preservation of the contralateral lobe) is indicated for patients with a unilateral thyroid mass that is causing compressive symptoms, cosmetic concern or to exclude thyroid carcinoma.

The incidence and risk factors for development of hypothyroidism after hemithyroidectomy remain unclear. The reported rates of postoperative hypothyroidism vary from 5.0% to 41.9 % because of variable follow-up and definition of hypothyroidism (Wormald et al). There are no nationally nor universally accepted guidelines for the monitoring of thyroid function after hemithyroidectomy.

Subclinical hypothyroidism is associated with an increased risk of coronary heart events and coronary heart mortality (Rodondi et al) and a high level of thyrotropin (within the laboratory reference range) has been related to an increased risk of fatal coronary heart disease (Asvold et al) Variation in thyroid function is seen between individuals also within the normal range. The individual variation in serum levels of thyroid hormones and thyrotropin between measurements in the same individual is relatively small compared with variations between individuals (Andersen et al). This implicates that around half of the laboratory reference range for thyrotropin is abnormal for a given individual. The fact that a thyrotropin value of an individual can be within the reference range but still represent an abnormal thyroid function in that given person has consequences for the monitoring of thyroid function after hemithyroidectomy. It implies that the postoperative thyroid function should be monitored by having the preoperative thyroid function in mind and that postoperative hypothyroidism should be understood in a broader term. After hemithyroidectomy a change in the individual unique set point that results in a lowered thyroid function can represent a condition that the investigators refer to as individual subclinical hypothyroidism.

Weight gain following hemithyroidectomy for benign nodular goiter among patients that do not develop overt hypothyroidism is a frequent clinical observation. Body weight is influenced by many factors, there among thyroid function. Even small differences in thyroid function with s-thyrotropin variations within the normal laboratory range for patients on T4 substitution therapy are associated with differences in resting energy expenditure. A prolonged decrease in REE could lead to increased body weight (al-Adsani et al).

Overweight and obesity are major threats to public health. The importance of lifestyle for weight gain is not to be doubted but other factors such as slight differences in thyroid function might be of importance in the risk of gaining weight as well (Knudsen et al).

The mitochondria provide cellular energy by converting oxygen and nutrients into ATP by aerobe respiration and mitochondrial energy production is regulated by thyroid hormones (Weitzel et al). Subclinical hypothyroidism has previously been shown to affect mitochondrial function in mononuclear blood cells (Kvetny et al).

The investigators hypothesize that after hemithyroidectomy some patients develop lowered thyroid function which results in a postoperative higher value of serum thyrotropin as a consequence of less negative feed-back on the pituitary gland. Weather the postoperative lowered thyroid function results in overt hypothyroidism (serum thyrotropin above the upper reference limit, lowered serum levels of free T3 and T4), subclinical (serum thyrotropin above the upper reference limit, free T3 and T4 within the reference range) or individual subclinical hypothyroidism (serum thyrotropin rises within the reference range, free T3 and T4 within the reference range) depends on the preoperative set point of thyroid function of the given patient but either condition represents a condition that is abnormal. The investigators hypothesize that a postoperative lowered thyroid function will affect mitochondrial function and result in weight gain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

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 Zealand
      • Slagelse, Region Zealand, Denmark, 4200
        • Recruiting
        • Slagelse Hospital, Hospital South
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is patients who meet the inclusion criteria and who are going to undergo hemithyroidectomy at Slagelse Hospital in Region Zealand, Denmark. The study subjects are are invited to participate by letter after the operation date is been scheduled.

Description

Inclusion Criteria:

  • Is going to undergo hemithyroidectomy for nontoxic goiter at the department of otorhinolaryngology at Slagelse Hospital, Denmark.
  • BMI 20-40
  • No past thyroid diseases
  • No medication with influence on the pituitary-thyroid axis
  • No hormone replacement therapy
  • No childbirth or pregnancy within the last year
  • Not currently breastfeeding

Exclusion Criteria:

  • Malignant goiter, diagnosed by histological examination of the resected tissue
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Hemithyroidectomy
Patients with benign nontoxic goiter who have an indication for hemithyroidectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in mitochondrial function from baseline value (before hemithyroidectomy)
Time Frame: 12 months after hemithyroidectomy
Mitochondrial function is examined by 1) measurement of mitochondrial mass and mitochondrial membrane potential by flow cytometry and by 2) examination of expression of mitochondrial-related genes measured by real time PCR.
12 months after hemithyroidectomy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body weight and body composition from baseline value (before hemithyroidectomy)
Time Frame: 12 months after hemithyroidectomy
Body weight and body composition is measured by weight in kilograms and by bioelectrical impedance analysis
12 months after hemithyroidectomy

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Naestved Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Zealand
Denmark:Department of Otorhinolaryngology Slagelse Hospital, Hospital South

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJ-10

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