LEVOTHYROXINE SODIUM for Obesity | Subclinical hypothyroidism | Metabolic disease

Inclusion criteria

• {"criterion_text":"- Subjects between 25-60 years old."}
• {"criterion_text":"- Grade I-II obesity (defined by a BMI between 30-39.9 Kg/m2)."}
• {"criterion_text":"- Subclinical hypothyroidism (TSH between 5 and 10 with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference levels."}
• {"criterion_text":"- Provide informed consent before inclusion in this study."}

Exclusion criteria

• {"criterion_text":"- 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)."}
• {"criterion_text":"- Any degree of heart failure; baseline resting heart rate greater than 85 bpm; renal insufficiency with glomerular filtration less than 60 ml/min."}
• {"criterion_text":"- Known HIV, HBV, HCV infection."}
• {"criterion_text":"- Evidence of acute inflammatory disease. Presence of inflammatory bowel disease."}
• {"criterion_text":"- Serious underlying diseases, which at the researcher´s discretion, could affect the patient´s ability to participate in the study."}
• {"criterion_text":"- Evidence of drug or alcohol abuse; expectation of reduced life (<12 months). Impossibility of following recommended diet; inability to follow program visits."}
• {"criterion_text":"- Positive screening pregnancy test, pregnant or expectation of pregnancy and lactating women."}
• {"criterion_text":"- Inability or unwillingness to give informed consent."}
• {"criterion_text":"- 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 The main reason for withdrawn must be recorded on the appropriate page of the data collection document. The reasons for the patient's withdrawn by the investigator include, but are not limited to, the following: - Presence of hyperthyroidism symptoms and signs of overt hyperthyroidism (it will be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."}
• {"criterion_text":"- Previous diagnosis of thyroid disease (hyperthyroidism, clinical hypothyroidism or previously treated with levothyroxine)."}
• {"criterion_text":"- Be receiving treatment with levothyroxine or any hypoglycaemic or have received either of the two up to 3 months before entering the study."}
• {"criterion_text":"- Regular consumption of probiotics or prebiotics or the consumption of antibiotics during the 3 months prior to inclusion."}
• {"criterion_text":"- Previous history of cancer (except basalioma) in the last 5 years or active cancer of any kind."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Establish cardiovascular disease, such as cerebrovascular accidents, ischemic heart disease, peripheral artery disease, among others."}
• {"criterion_text":"- Previous history of atrial fibrillation or any arrhythmia."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Weight loss (measured in percentage (%) and kilograms (kg)) and body composition changes (BMI, waist/hip circumference, fat mass, fat free mass, body water by impedance measurement) from baseline to the end of intervention program at 3 months (sample size: 286 subjects).","definition_or_measurement_approach":"Weight loss measured as percentage and kilograms; body composition changes assessed by BMI, waist/hip circumference, fat mass, fat free mass, body water measured by impedance from baseline to 3 months."}

Secondary endpoints

• {"endpoint_text":"- Weight Regain Prevention Rate in patients who previously underwent a weight loss intervention (the same parameters as on the endpoint will be measured) from month three untill the end of the treatment.","definition_or_measurement_approach":"Same parameters as primary endpoint measured from month 3 until end of treatment to evaluate weight regain prevention rate."}
• {"endpoint_text":"- Changes in the stage of obesity (obesity type I and II) measured by changes in BMI.","definition_or_measurement_approach":"Stage change assessed by BMI category changes (obesity type I and II) based on BMI measurements."}
• {"endpoint_text":"- Changes in cardiovascular risk factors: lipids, blood pressure, glucose, HbA1c, HOMA-IR, adipokines and inflammation markers.","definition_or_measurement_approach":"Laboratory and clinical measures: lipid panels, blood pressure, glucose, HbA1c, HOMA-IR, adipokines and inflammation biomarkers."}
• {"endpoint_text":"- Changes in resting energy expenditure determined by indirect calorimetry.","definition_or_measurement_approach":"Resting energy expenditure measured using indirect calorimetry."}
• {"endpoint_text":"- Differences in the degree of physical activity quantified by accelerometry.","definition_or_measurement_approach":"Physical activity quantified via accelerometer data."}
• {"endpoint_text":"- Changes in cardiac function: heart rate, ventricular extrasystoles, QT interval (EKG); and the apparition of side effects and adverse reactions.","definition_or_measurement_approach":"Cardiac function assessed by ECG (heart rate, ventricular extrasystoles, QT interval) and monitoring of adverse events."}
• {"endpoint_text":"- Changes in metabolic activity of adipose tissue.","definition_or_measurement_approach":"Assessment of metabolic activity in adipose tissue (method not further specified in summary)."}
• {"endpoint_text":"- Gut microbiota analysis, epigenetic studies and analysis of genes related to obesity.","definition_or_measurement_approach":"Microbiota, epigenetic and gene analyses performed on appropriate biological samples (methods not further specified in summary)."}
• {"endpoint_text":"- Changes in nitrogen balance.","definition_or_measurement_approach":"Nitrogen balance measured by appropriate biochemical assays (not further specified)."}
• {"endpoint_text":"- Define gender, as a determining factor in reaching the primary endpoint and secondary outcomes.","definition_or_measurement_approach":"Gender-stratified analyses to assess influence on primary and secondary outcomes."}
• {"endpoint_text":"- Changes in quality of life (EuroQol-5D quality of life questionnaire).","definition_or_measurement_approach":"Quality of life measured using the EuroQol-5D questionnaire."}

Spain

Earliest CTIS Part Ii Submission Date

19-07-2024

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

377

Number Of Sites

5

Number Of Participants

286

Primary sponsor

Full Name

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain