ThyrOp: A Study of Individual Subclinical Hypothyroidism After Hemithyroidectomy for Benign Nontoxic Goiter (ThyrOp)
|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
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 Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
Patients with benign nontoxic goiter who have an indication for hemithyroidectomy
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358136
|Slagelse Hospital, Hospital South||Recruiting|
|Slagelse, Region Zealand, Denmark, 4200|
|Contact: Tina Toft Kristensen, MD +45 5651 2217/+45 2381 1617 firstname.lastname@example.org|