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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Tina Toft Kristensen, Naestved Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358136
First Posted: May 23, 2011
Last Update Posted: April 25, 2012
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. Read our disclaimer for details.
Collaborators:
Denmark:Department of Otorhinolaryngology Slagelse Hospital, Hospital South
Region Zealand
Information provided by (Responsible Party):
Tina Toft Kristensen, Naestved Hospital
  Purpose

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.


Condition
Goiter Hypothyroidism Weight Gain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ThyrOp: Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter - Focus on Weight Gain and Mitochondrial Dysfunction

Resource links provided by NLM:


Further study details as provided by Tina Toft Kristensen, Naestved Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemithyroidectomy
Patients with benign nontoxic goiter who have an indication for hemithyroidectomy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
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): NCT01358136


Locations
Denmark
Slagelse Hospital, Hospital South Recruiting
Slagelse, Region Zealand, Denmark, 4200
Contact: Tina Toft Kristensen, MD    +45 5651 2217/+45 2381 1617    tikr@regionsjaelland.dk   
Sponsors and Collaborators
Naestved Hospital
Denmark:Department of Otorhinolaryngology Slagelse Hospital, Hospital South
Region Zealand
  More Information

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.
Wormald 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.
Andersen 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.
al-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.
Knudsen N, Laurberg P, Rasmussen LB, Bülow I, Perrild H, Ovesen L, Jørgensen 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. Epub 2005 May 3.
Weitzel JM, Iwen KA, Seitz HJ. Regulation of mitochondrial biogenesis by thyroid hormone. Exp Physiol. 2003 Jan;88(1):121-8. Review.
Rodondi 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.
Asvold BO, Bjøro 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.

Responsible Party: Tina Toft Kristensen, Ph.D Student, MD, Naestved Hospital
ClinicalTrials.gov Identifier: NCT01358136     History of Changes
Other Study ID Numbers: SJ-10
First Submitted: May 18, 2011
First Posted: May 23, 2011
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Tina Toft Kristensen, Naestved Hospital:
Thyroidectomy
Mitochondria

Additional relevant MeSH terms:
Weight Gain
Hypothyroidism
Goiter
Body Weight Changes
Body Weight
Signs and Symptoms
Thyroid Diseases
Endocrine System Diseases


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