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Effect of levothyroxine on kidney function in patients at risk of hypothyroidism after partial thyroid surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals at risk of developing Hypothyroidism, a condition where the thyroid gland does not produce enough hormones to meet the body's needs, following a Hemithyroidectomy, which is the surgical removal of half of the thyroid gland. The research aims to evaluate whether starting treatment with Levothyroxine early after surgery affects kidney health and overall well-being. Potential risks being investigated include Incident Kidney Dysfunction, which refers to a sudden decline in how well the kidneys work, and Chronic Kidney Disease, a long-term condition where the kidneys cannot filter blood as well as they should.

Participants in the study may receive different doses of Levothyroxine Sodium or a placebo. During the study, monitoring will involve checking levels of hormones such as TSH, T4, and T3 in the blood to see how the body is responding to the treatment. Other factors being observed include eGFR, which is a measurement used to check how well the kidneys are filtering waste from the blood, as well as changes in body weight and BMI. The study will follow participants over several months to observe these changes and assess their health-related quality of life.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of the trial
After joining the study, the thyroid hormone replacement treatment begins. this treatment is used to manage hypothyroidism, a condition where the thyroid gland does not produce enough hormones.
The treatment involves taking levothyroxine, a medication taken by mouth. depending on the assigned group, the dosage will be either 100 micrograms or 270 micrograms.
Step 2
Three-month follow-up
At 3 months after the surgery, several assessments are conducted. these include blood tests to measure TSH, T4, and T3 (levels of thyroid hormones in the blood) and to check the eGFR, which is a measure used to evaluate kidney function.
Assessments are also performed to evaluate quality of life using a questionnaire, as well as measurements of body weight and body mass index (BMI).
Step 3
Six-month follow-up
At 6 months after the surgery, further evaluations are conducted. these include checking the quality of life scores, body weight, and body mass index (BMI).
For participants in the control group who begin thyroid hormone replacement therapy at the 3-month mark due to elevated TSH levels, additional checks of kidney function and quality of life are performed at this stage.

Who can join the trial?

6 criteria

You must be at least 18 years old.
You must be scheduled for your first hemithyroidectomy, which is a surgery to remove only one half of the thyroid gland (the butterfly-shaped gland in your neck).
Your TSH (thyroid-stimulating hormone, a hormone that tells your thyroid how to work) must be 2 mUI/L or higher.
Your eGFR (estimated glomerular filtration rate, a test that shows how well your kidneys are filtering your blood) must be greater than 30 mL/min/1.73m2.
You must be able to understand all information about the study and provide your written informed consent, which means signing a document agreeing to participate.
You must be able and willing to follow the study rules and attend all scheduled visits.

Who cannot join the trial?

12 criteria

If you have had a previous thyroid operation, which is a surgery performed on the thyroid gland located in the neck.
If you have started taking ACE inhibitors, ARB, or SGLT2 medications after your surgery. These are specific types of drugs often used to manage blood pressure or protect the kidneys.
If you are unable to understand the Danish language or cannot provide informed consent, which means giving your official permission to join the study after understanding all the details.
If you are currently taking part in another interventional study, which is a medical research trial where participants receive a specific treatment or intervention.
If you have a planned total thyroidectomy, which is a surgery to remove the entire thyroid gland, scheduled during the follow-up period of this study.
If you are using Thycapsol or similar medicines that directly affect your thyroid hormones, which are chemicals produced by the thyroid to regulate how your body uses energy.
If you are having a simultaneous operation for primary hyperparathyroidism, a condition where one or more of the parathyroid glands (small glands in the neck) become overactive.
If you are pregnant or planning to become pregnant during the time after your surgery.
If you have received cancer treatment within the last three years.
If there is a history of narcotics use or alcohol abuse.
If you have a severe illness, such as a psychiatric disorder (a serious mental health condition) or kidney disease with a GFR of less than 30. GFR, or glomerular filtration rate, is a measure of how well your kidneys are filtering waste from your blood.
If you have severe cardiovascular disease, which refers to serious problems with the heart or blood vessels, such as atrial fibrillation (an irregular and often rapid heart rate) or heart failure (a condition where the heart cannot pump enough blood to meet the body's needs).

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Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Levothyroxine is a medication used to replace a hormone that the thyroid gland normally produces. In this study, it is being tested to see if providing this hormone to patients after thyroid surgery can help improve kidney function and overall quality of life.

Levothyroxine

What is already known about the treatment

Levothyroxine - This medication is taken by mouth in the form of a pill to treat an underactive thyroid, a condition known as hypothyroidism. It is a widely used hormone replacement therapy that functions by mimicking the natural thyroid hormone produced by the body. At a molecular level, it works by binding to specific receptors in your cells to help regulate how your body uses energy and maintains vital functions. This drug is classified as a thyroid hormone replacement.

Investigated diseases

Hypothyroidism
This condition occurs when the thyroid gland does not produce enough essential hormones. It can result from the gland being damaged or failing to receive proper signals from the brain. As the hormone levels drop, various bodily processes begin to slow down. This change can affect metabolism, energy levels, and temperature regulation. The progression varies depending on the underlying cause of the hormone deficiency.
Chronic Kidney Disease
This is a long-term condition characterized by a gradual loss of kidney function over time. The kidneys slowly lose their ability to filter waste products and excess fluids from the blood. As the disease progresses, the filtration rate decreases, which can lead to a buildup of substances in the body. This process is often continuous and can worsen over many months or years.
Incident Kidney Dysfunction
This term refers to the new onset of impaired kidney function in an individual. It represents a transition from healthy kidney performance to a state where the kidneys are not working as efficiently as they should. This change is identified when kidney function markers move outside of the normal range for the first time. It serves as an indicator that the kidneys are experiencing a decline in their ability to filter blood.