Effect of Body Composition on Thyroid Hormone Levels Among Overweight and Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Thyroid hormones (FT3, FT4)
研究概览
简要总结
The study was aimed at investigating the relationship between body composition and thyroid hormone levels in overweight and obese subjects (BMI≥25 Kg/m2)
详细描述
Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP), bioimpedance and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obesity (BMI> 25 Kg/m2)
排除标准
- •Any kind of drug
- •Hypertension
- •Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
- •Chronic inflammatory diseases
- •Renal failure
- •Liver failure
- •Angina pectoris
- •Myocardial infarction and heart failure
- •Genetic heart diseases
- •Thrombocytopenias
结局指标
主要结局
Thyroid hormones (FT3, FT4)
时间窗: Baseline
FT3 (pg/mL), FT4 (pg/mL) concentration in serum
skeletal muscle mass
时间窗: Baseline
skeletal muscle mass (kg)
TSH
时间窗: At baseline
TSH (mU/L) concentration in serum
次要结局
- HDL cholesterol(Baseline)
- Insulin(Baseline)
- Total cholesterol(Baseline)
- Weight(Baseline)
- Vitamin D(Baseline)
- eGFR (estimated glomerular filtration rate)(Baseline)
- LDL cholesterol(Baseline)
- BMI(Baseline)
- Height(Baseline)
- Creatinin(Baseline)
研究者
Gianluigi Giannelli
Clinical Professor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
