GoiterThyrOpNCT01358136
ThyrOp: A Study of Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter
An observational study of Goiter and Hypothyroidism, run by Naestved Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Goiter, Hypothyroidism, Weight Gain
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Malignant goiter, diagnosed by histological examination of the resected tissue
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Slagelse Hospital, Hospital South
Slagelse, Region Sjælland, 4200
Tina Toft Kristensen, MD, +45 5651 2217/+45 2381 1617, tikr@regionsjaelland.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Goiter, Hypothyroidism, Weight Gain
- Keywords
- Thyroidectomy, Mitochondria
- Medical subject headings
- Goiter, Hypothyroidism, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemithyroidectomy | Patients with benign nontoxic goiter who have an indication for hemithyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitochondrial function from baseline value (before 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.
Measured: 12 months after hemithyroidectomy
Secondary outcomes (1)
Change in body weight and body composition from baseline value (before hemithyroidectomy)
Body weight and body composition is measured by weight in kilograms and by bioelectrical impedance analysis
Measured: 12 months after hemithyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GoiterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Denmark:Department of Otorhinolaryngology Slagelse Hospital, Hospital South, Region Zealand
- Responsible party
- Principal investigator, Tina Toft Kristensen, Naestved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358136
- Sponsor's protocol ID
- SJ-10
- Acronym
- ThyrOp
- Status last verified
- Apr 2012
- First submitted
- 18 May 2011
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kvetny J, Wilms L, Pedersen PL, Larsen J. Subclinical hypothyroidism affects mitochondrial function. Horm Metab Res. 2010 May;42(5):324-7. doi: 10.1055/s-0030-1248261. Epub 2010 Feb 22.
PubMed 20178065Wormald R, Sheahan P, Rowley S, Rizkalla H, Toner M, Timon C. Hemithyroidectomy for benign thyroid disease: who needs follow-up for hypothyroidism? Clin Otolaryngol. 2008 Dec;33(6):587-91. doi: 10.1111/j.1749-4486.2008.01794.x.
PubMed 19126134Andersen S, Pedersen KM, Bruun NH, Laurberg P. Narrow individual variations in serum T(4) and T(3) in normal subjects: a clue to the understanding of subclinical thyroid disease. J Clin Endocrinol Metab. 2002 Mar;87(3):1068-72. doi: 10.1210/jcem.87.3.8165.
PubMed 11889165al-Adsani H, Hoffer LJ, Silva JE. Resting energy expenditure is sensitive to small dose changes in patients on chronic thyroid hormone replacement. J Clin Endocrinol Metab. 1997 Apr;82(4):1118-25. doi: 10.1210/jcem.82.4.3873.
PubMed 9100583Knudsen N, Laurberg P, Rasmussen LB, Bulow I, Perrild H, Ovesen L, Jorgensen T. Small differences in thyroid function may be important for body mass index and the occurrence of obesity in the population. J Clin Endocrinol Metab. 2005 Jul;90(7):4019-24. doi: 10.1210/jc.2004-2225. Epub 2005 May 3.
PubMed 15870128Weitzel JM, Iwen KA, Seitz HJ. Regulation of mitochondrial biogenesis by thyroid hormone. Exp Physiol. 2003 Jan;88(1):121-8. doi: 10.1113/eph8802506.
PubMed 12552316Rodondi N, den Elzen WP, Bauer DC, Cappola AR, Razvi S, Walsh JP, Asvold BO, Iervasi G, Imaizumi M, Collet TH, Bremner A, Maisonneuve P, Sgarbi JA, Khaw KT, Vanderpump MP, Newman AB, Cornuz J, Franklyn JA, Westendorp RG, Vittinghoff E, Gussekloo J; Thyroid Studies Collaboration. Subclinical hypothyroidism and the risk of coronary heart disease and mortality. JAMA. 2010 Sep 22;304(12):1365-74. doi: 10.1001/jama.2010.1361.
PubMed 20858880Asvold BO, Bjoro T, Nilsen TI, Gunnell D, Vatten LJ. Thyrotropin levels and risk of fatal coronary heart disease: the HUNT study. Arch Intern Med. 2008 Apr 28;168(8):855-60. doi: 10.1001/archinte.168.8.855.
PubMed 18443261
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThyrOp: Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter - Focus on Weight Gain and Mitochondrial Dysfunction
- ClinicalTrials.gov ID
- NCT01358136
- Acronym / sponsor ID
- ThyrOp / SJ-10
- Conditions
- Goiter, Hypothyroidism, Weight Gain
- Keywords
- Thyroidectomy, Mitochondria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- Denmark:Department of Otorhinolaryngology Slagelse Hospital, Hospital South, Region Zealand
- Study start
- May 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemithyroidectomy | – | –Patients with benign nontoxic goiter who have an indication for hemithyroidectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Malignant goiter, diagnosed by histological examination of the resected tissue
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Change in body weight and body composition from baseline value (before hemithyroidectomy)
Time frame: 12 months after hemithyroidectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
- Background: PubMed 20178065Kvetny J, Wilms L, Pedersen PL, Larsen J. Subclinical hypothyroidism affects mitochondrial function. Horm Metab Res. 2010 May;42(5):324-7. doi: 10.1055/s-0030-1248261. Epub 2010 Feb 22.
- Background: PubMed 19126134Wormald R, Sheahan P, Rowley S, Rizkalla H, Toner M, Timon C. Hemithyroidectomy for benign thyroid disease: who needs follow-up for hypothyroidism? Clin Otolaryngol. 2008 Dec;33(6):587-91. doi: 10.1111/j.1749-4486.2008.01794.x.
- Background: PubMed 11889165Andersen S, Pedersen KM, Bruun NH, Laurberg P. Narrow individual variations in serum T(4) and T(3) in normal subjects: a clue to the understanding of subclinical thyroid disease. J Clin Endocrinol Metab. 2002 Mar;87(3):1068-72. doi: 10.1210/jcem.87.3.8165.
- Background: PubMed 9100583al-Adsani H, Hoffer LJ, Silva JE. Resting energy expenditure is sensitive to small dose changes in patients on chronic thyroid hormone replacement. J Clin Endocrinol Metab. 1997 Apr;82(4):1118-25. doi: 10.1210/jcem.82.4.3873.
- Background: PubMed 15870128Knudsen N, Laurberg P, Rasmussen LB, Bulow I, Perrild H, Ovesen L, Jorgensen T. Small differences in thyroid function may be important for body mass index and the occurrence of obesity in the population. J Clin Endocrinol Metab. 2005 Jul;90(7):4019-24. doi: 10.1210/jc.2004-2225. Epub 2005 May 3.
- Background: PubMed 12552316Weitzel JM, Iwen KA, Seitz HJ. Regulation of mitochondrial biogenesis by thyroid hormone. Exp Physiol. 2003 Jan;88(1):121-8. doi: 10.1113/eph8802506.
- Background: PubMed 20858880Rodondi N, den Elzen WP, Bauer DC, Cappola AR, Razvi S, Walsh JP, Asvold BO, Iervasi G, Imaizumi M, Collet TH, Bremner A, Maisonneuve P, Sgarbi JA, Khaw KT, Vanderpump MP, Newman AB, Cornuz J, Franklyn JA, Westendorp RG, Vittinghoff E, Gussekloo J; Thyroid Studies Collaboration. Subclinical hypothyroidism and the risk of coronary heart disease and mortality. JAMA. 2010 Sep 22;304(12):1365-74. doi: 10.1001/jama.2010.1361.
- Background: PubMed 18443261Asvold BO, Bjoro T, Nilsen TI, Gunnell D, Vatten LJ. Thyrotropin levels and risk of fatal coronary heart disease: the HUNT study. Arch Intern Med. 2008 Apr 28;168(8):855-60. doi: 10.1001/archinte.168.8.855.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slagelse Hospital, Hospital South
Slagelse, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Goiter and Hypothyroidism, run by Naestved Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mitochondrial function from baseline value (before hemithyroidectomy) (time frame: 12 months after hemithyroidectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01358136, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.