Assessment of Anthropometric Parameters, Protein and Metabolic Profile and Function of the Respiratory System in Obese Patients Reducing Their Body Mass Under Controlled Conditions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Satisfaction with Life Scale
研究概览
简要总结
Obesity is currently considered an increasingly more severe social and health related problem. The World Health Organization qualified obesity as a chronic disease along with circulatory diseases, diabetes, cancer and respiratory diseases. The principal physiological methods of treatment for this disease are diet and exercise. The aim of the study is assess anhtropometric parameters, metabolic and proteomic profile and respiratory truck function in obese patients reducing body weight during 21 days course of calorie restriction and physical activity.
详细描述
THE AIM OF THE STUDY:
Determining changes in anthropometric parameters, both the protein and metabolic profile as well as changes in the respiratory system functional testing in obese patients, in whom an attempt to reduce body mass (through dietary treatment and physical activity), under controlled conditions (over a period of a 21-day hospitalization) was made.
RESEARCH METHODOLOGY:
The study will be conducted on a group of a 100 persons with obesity who fulfilled the inclusion criteria (index BMI>30 kg/m2/ and an increased adipose tissue content assessed by the electrical bioimpedance method)
RESEARCH PLAN
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient's age: above 18 years of age
- •BMI obesity >30kg/m2
- •increased content of overall adipose tissue measured by bioelectrical impendance method
- •consent to take part in the study
排除标准
- •positive electrocardiographic stress test
- •staying on a vegetarian or any other alternative diet
- •patients with active or post cancerous disease (ongoing radiation-/chemotherapy treatment),
- •patients with liver diseases (ALT > 3x border line ) except for patients with fatty live disease,
- •chronic kidney disease eGFR <30 ml/ 1,73m2 / min,
- •acute inflammation CRP > 5mg/dl,
- •unstable ischeamic heart disease, state after bypass surgery, implanted heart stimulator- (cardioverter, defibrillator - ICD, heart pacemaker), endovascular prosthesis,
- •patients after an ischemic or haemorrhagic stroke (<6 months)
- •post STEMI patients with a drug-eluting stent implantation, nSTEMI (<12 months)
- •inherited metabolic disorders: phenylketonouria, galactosaemia
- •autoimmune diseases (an acute thyroiditis, celiac disease, systemic connective tissue disease, haemolytic anemia, vitiligo, addison's disease, hyperbilirubinemia),
- •non specific enteneritis (Crohn's disease, ulcerative colonitis)
- •psychological disorders, eating disorders such as anorexia, bulimia,
- •antibiotic therapy, steroid therapy, (ongoing)
- •drug, alcohol addiction (a daily consumption of more then 1 portion of alcohol).
结局指标
主要结局
Satisfaction with Life Scale
时间窗: after 12 months
SWLS Questionaire
adipose tissue
时间窗: after 12 months
The assessment of the body adipose tissue content using the electrical bioimpedance device- TANITA MC-980 MA.( Percentage )
Respiratory system tests
时间窗: after 12 months
spirometry (%)
次要结局
未报告次要终点
研究者
Agnieszka Zawada
principal investigator
Poznan University of Medical Sciences