Hepcidin Behavior in Patients With Obesity and Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Serum hepcidin concentration
研究概览
简要总结
Iron deficiency is one of the most common nutritional problems observed in patients with obesity and after bariatric surgery. From a therapeutic point of view, iron deficiency can lead to iron deficiency anemia. Iron supplementation carries the risk of exacerbating infections, altering the gut microbiome and iron overload. Therefore, it would be beneficial to use iron supplementation only in truly iron deficient patients. To date, different studies have observed that hepcidin could be a possible indicator of iron status and absorption in different patient populations. Furthermore, it could be used to distinguish anemia due to iron deficiency from inflammation and globin disorder related anemia. How hepcidin concentrations variate in patients with obesity and after bariatric surgery remains unsure.
详细描述
During the visit in the obesity clinic, eligible patients will be approached for participation by the sub-investigator. Interested patients will receive information regarding the study and receive the information sheet containing the informed consent form. After signing the informed consent form, general information will be collected regarding medical and demographic data using a short questionnaire. Additional questionnaires regarding demographics and menstrual cycle will be collected. Anthropometric measurements will be collected for the determination of the length, weight, hip circumference, waist circumference and body composition. Finally, blood samples will be collected for the determination of iron and inflammation related markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient has to be 18 years or older
- •Written informed consent has to be obtained after being informed on all aspects of the study
- •The patient has a BMI > 30 kg/m² OR There has to be at least one year between the primary RYGB and the participation in the study OR There has to be at least one year between the primary SG and the participation in the study
排除标准
- •Patients younger than 18 years old
- •Women who are pregnant or are breastfeeding
- •Post-menopausal women, defined as at least 6 months of amenorrhea after the final menstrual period
- •Inability to follow the procedures of the studies due to language problems
- •Patients who have had more than one bariatric surgery
结局指标
主要结局
Serum hepcidin concentration
时间窗: Study visit 1 day
Serum hepcidin concentration
次要结局
- Hemoglobin concentration(Study visit 1 day)
- Mean corpuscular volume(Study visit 1 day)
- Folate (serum level)(Study visit 1 day)
- Iron concentration(Study visit 1 day)
- Transferrin concentration(Study visit 1 day)
- Transferrin saturation(Study visit 1 day)
- Ferritin concentration(Study visit 1 day)
- Vitamin B12 concentration(Study visit 1 day)
- Folate (RBC level)(Study visit 1 day)
- C-reactive protein(Study visit 1 day)