2024-514377-22-00招募中3 期
Effect of levothyroxine as adjuvant therapy to a hypocaloric diet in the treatment of obesity: a randomized placebo-controlled trial.
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud5 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2024年9月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 5
- 主要终点
- 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).
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 The main reason for withdrawn must be recorded on the appropriate page of the data collection document.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.
结局指标
主要结局
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).
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).
次要结局
- 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.
- Changes in the stage of obesity (obesity type I and II) measured by changes in BMI.
- Changes in cardiovascular risk factors: lipids, blood pressure, glucose, HbA1c, HOMA-IR, adipokines and inflammation markers.
- Changes in resting energy expenditure determined by indirect calorimetry.
- Differences in the degree of physical activity quantified by accelerometry.
- Changes in cardiac function: heart rate, ventricular extrasystoles, QT interval (EKG); and the apparition of side effects and adverse reactions.
- Changes in metabolic activity of adipose tissue.
- Gut microbiota analysis, epigenetic studies and analysis of genes related to obesity.
- Changes in nitrogen balance.
- Define gender, as a determining factor in reaching the primary endpoint and secondary outcomes.
- Changes in quality of life (EuroQol-5D quality of life questionnaire).
研究者
Isabel María Cornejo
Scientific
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
研究点 (5)
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