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

This study is currently recruiting participants.
Verified April 2012 by Naestved Hospital
Sponsor:
Collaborators:
Denmark:Department of Otorhinolaryngology Slagelse Hospital, Hospital South
Denmark:Research Unit of Region Zealand, Hospital South
Denmark:Fund of Health Research, Region Zealand
Information provided by (Responsible Party):
Tina Toft Kristensen, Naestved Hospital
ClinicalTrials.gov Identifier:
NCT01358136
First received: May 18, 2011
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  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:

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Further study details as provided by Naestved Hospital:

Primary Outcome Measures:
  • Change in mitochondrial function from baseline value (before hemithyroidectomy) [ Time Frame: 12 months after hemithyroidectomy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Denmark:Research Unit of Region Zealand, Hospital South
Denmark:Fund of Health Research, 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
Study First Received: May 18, 2011
Last Updated: April 24, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Naestved Hospital:
Thyroidectomy
Mitochondria

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

ClinicalTrials.gov processed this record on June 13, 2013