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

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ClinicalTrials.gov Identifier: NCT01358136
Recruitment Status : Unknown
Verified April 2012 by Tina Toft Kristensen, Naestved Hospital.
Recruitment status was:  Recruiting
First Posted : May 23, 2011
Last Update Posted : April 25, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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. 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 or disease
Goiter Hypothyroidism Weight Gain

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Hemithyroidectomy
Patients with benign nontoxic goiter who have an indication for hemithyroidectomy


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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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:

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 Posted: May 23, 2011    Key Record Dates
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