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Effect of levothyroxine and hypocaloric diet for the treatment of obesity.
EU CTIS ID: 2024-514377-22-00
What this study is testing
To evaluate the effect of adjuvant treatment with levothyroxine together with a hypocaloric diet and physical exercise recomendations, compared with placebo together with the same lifestyle strategy, on weight loss and body composition at 3 months, in subjects with obesity and subclinical hypothyroidism or euthyroidism with TSH levels in the upper tertile of the normal range for the population without thyroid disease.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects between 25-60 years old.
- Grade I-II obesity (defined by a BMI between 30-39.9 Kg/m2).
- Subclinical hypothyroidism (TSH between 5 and 10 with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference levels.
- Provide informed consent before inclusion in this study.
You likely can't join if
- Previous diagnosis of diabetes mellitus (defined by HbA1c ≥6.5% or baseline blood glucose ≥=126mg/dl or blood glucose after 2 hours of oral glucose tolerance test ≥200 mg/dl).
- Any degree of heart failure; baseline resting heart rate greater than 85 bpm; renal insufficiency with glomerular filtration less than 60 ml/min.
- Known HIV, HBV, HCV infection.
- Evidence of acute inflammatory disease. Presence of inflammatory bowel disease.
- Serious underlying diseases, which at the researcher´s discretion, could affect the patient´s ability to participate in the study.
- Evidence of drug or alcohol abuse; expectation of reduced life (<12 months). Impossibility of following recommended diet; inability to follow program visits.
See the full eligibility criteria
- Subjects between 25-60 years old.
- Grade I-II obesity (defined by a BMI between 30-39.9 Kg/m2).
- Subclinical hypothyroidism (TSH between 5 and 10 with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference levels.
- Provide informed consent before inclusion in this study.
- Previous diagnosis of diabetes mellitus (defined by HbA1c ≥6.5% or baseline blood glucose ≥=126mg/dl or blood glucose after 2 hours of oral glucose tolerance test ≥200 mg/dl).
- Any degree of heart failure; baseline resting heart rate greater than 85 bpm; renal insufficiency with glomerular filtration less than 60 ml/min.
- Known HIV, HBV, HCV infection.
- Evidence of acute inflammatory disease. Presence of inflammatory bowel disease.
- Serious underlying diseases, which at the researcher´s discretion, could affect the patient´s ability to participate in the study.
- Evidence of drug or alcohol abuse; expectation of reduced life (<12 months). Impossibility of following recommended diet; inability to follow program visits.
- Positive screening pregnancy test, pregnant or expectation of pregnancy and lactating women.
- Inability or unwillingness to give informed consent.
- Patients can leave the study at any time by voluntary withdrawal. The main reason for withdrawn must be recorded on the appropriate page of the data collection document. The reasons for the patient's withdrawn by the investigator include, but are not limited to, the following: - Presence of hyperthyroidism symptoms and signs of overt hyperthyroidism (it will be confirmed by analysis). - Non-compliance by the patient and/or researcher with the study procedures and guidelines. - Any significant adverse event that compromises the patient's safety or their ability to participate in the study. - The investigator's determination that continuing is not in the interest of the patient. In addition to the aforementioned, the Investigator (IP) may withdraw any patient from the study if, in their medical judgment, remaining in the trial may be detrimental to the patient's health.
- Previous diagnosis of thyroid disease (hyperthyroidism, clinical hypothyroidism or previously treated with levothyroxine).
- Be receiving treatment with levothyroxine or any hypoglycaemic or have received either of the two up to 3 months before entering the study.
- Regular consumption of probiotics or prebiotics or the consumption of antibiotics during the 3 months prior to inclusion.
- Previous history of cancer (except basalioma) in the last 5 years or active cancer of any kind.
- Chronic liver disease with impaired liver function detected: total bilirubin levels ≥2.0 mg/dl or AST levels three times higher than the normal upper limit.
- Establish cardiovascular disease, such as cerebrovascular accidents, ischemic heart disease, peripheral artery disease, among others.
- Previous history of atrial fibrillation or any arrhythmia.
- Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) despite adequate antihypertensive therapy. For the evaluation of this criteria will be considered the ABPM measures during the screening period.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.