ThyrOp: A Study of Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter (ThyrOp)
Recruitment status was: Recruiting
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 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|
- 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.
- 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
|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)|
Patients with benign nontoxic goiter who have an indication for hemithyroidectomy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01358136
|Slagelse Hospital, Hospital South|
|Slagelse, Region Zealand, Denmark, 4200|