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Levothyroxine as Adjuvant to a Hypocaloric Diet for the Treatment of Obesity.

RecruitingPhase 3Ages 25 Years - 60 YearsAllFundación Pública Andaluza para la Investigación …
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In plain words

What the trial is, and whether it could suit you

Obesity is a chronic disease with high relapse rates after initial weight loss. Thyroid hormones modulate energy expenditure, body composition, and thermogenesis; higher TSH within the reference range and subclinical hypothyroidism have been associated with adverse metabolic profiles and weight gain. These signals suggest the thyroid axis could influence weight-loss response and subsequent regain. Levothyroxine (LT4) is widely used for hypothyroidism; evaluating its adjuvant role in obesity management is clinically relevant. This is a phase III, randomized, double-blind, placebo-controlled, multicentre clinical trial conducted in five Spanish hospitals. A total of 286 adults (25-60 years) with grade I-II obesity will be enrolled if they have subclinical hypothyroidism (TSH 5-10 mIU/L with normal peripheral hormones) or are euthyroid with TSH in the highest tertile of the reference range

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Adults 25-60 years of age. * Obesity grade I-II: BMI 30.0-39.9 kg/m². * Either subclinical hypothyroidism (TSH 5-10 mIU/L with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference range (no known thyroid disease). * Able and willing to provide written informed consent. * Women of childbearing potential: not pregnant or breastfeeding and using a highly effective contraception method (failure rate \<1%) per CTCG guidance (e.g., hormonal methods, IUD/IUS, sterilization, or dual barrier with spermicide). Exclusion Criteria: * Diabetes mellitus (HbA1c ≥6.5%, fasting glucose ≥126 mg/dL, or 2-h OGTT ≥200 mg/dL). * Any prior thyroid disease (hyperthyroidism, overt hypothyroidism) or prior LT4 treatment. * Current or recent (≤3 months) use of levothyroxine, hypoglycaemic agents, antibiotics, or regular probiotics/prebiotics. * Active cancer or cancer within the last 5 years (except basal-cell carcinoma). * Chronic liver disease with total bilirubin ≥2.0 mg/dL or AST \>3× ULN. * Established cardiovascular disease (e.g., stroke, ischemic heart disease, peripheral artery disease). * Atrial fibrillation or any arrhythmia history. * Uncontrolled hypertension (\>160/100 mmHg) despite therapy (assessed by ABPM at screening). * Any heart failure; resting HR \>85 bpm; eGFR \<60 mL/min. * Known HIV, HBV, or HCV infection. * Acute inflammatory disease or inflammatory bowel disease. * Serious underlying disease that, in the investigator's judgment, could affect participation. * Drug/alcohol abuse, life expectancy \<12 months, inability to follow the recommended diet or attend visits. * Positive pregnancy test, pregnant, expecting pregnancy, or breastfeeding. * Hypersensitivity to any component of the investigational product. * Inability or unwillingness to provide informed consent.
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What it tests

  • Levothyroxine
  • Placebo
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Where

5 sites
Hospital Puerta del Mar
Cadiz, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital Universitario de Jaén
Jaén, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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