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

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.