BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment - Interaction With Gastrointestinal Microbiota, Psychiatric Morbidity and Socioeconomics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Ionized Calcium in serum
研究概览
简要总结
Weight-reducing obesity surgery (OS) generally gives good results but complications are common; e.g. impaired weight loss, weight regain, bowel pain, diarrhea, vitamin/mineral deficiency, osteoporosis and impaired dental health. The BASUN study is a prospective 10-year comparison of 1000 surgically and 400 conventionally treated individuals regarding adverse side-effects, risk factors for complications and poor outcome.
详细描述
The use of obesity surgery (OS) has increased dramatically due to the lack of effective conventional weight reducing methods. OS generally gives a sustained weight reduction and improves metabolic co-morbidities but complications are not uncommon, e.g. weight regain, bowel pain, diarrhea, vitamin/mineral deficiency, osteoporosis and impaired dental health. Studies of OS regarding adverse side-effects, risk factors for complications and poor outcomes are few or missing.
The BASUN study is a prospective 10-year comparison of 1000 surgically and 400 conventionally treated individuals. Inclusion started in April 2015 and will be completed in 2017. Subjects are consecutively included from the whole western region of Sweden and are followed by detailed checkups at 2, 5 and 10 years. Protocol includes nutritional and bone status, oral health, psychiatric health, GI symptoms, socioeconomics and health economy. Data are collected by interviews, blood and fecal samples, questionnaires, dual energy x-ray absorptiometry, dentist examinations, patients' record and registries. The study is carried out in close cooperation with experts in surgery, medicine, psychiatry, endocrinology, gastroenterology, hematology, molecular biology, osteoporosis, oral medicine, physiology and general medicine.
The BASUN study will be able to form the basis for more individualized medical guidelines with the objective of improving therapeutic quality and the utilization of health care resources.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients eligible for obesity treatment under specialist care with medical methods or with surgery
排除标准
- •no ability to speak, read or write in Swedish
结局指标
主要结局
Ionized Calcium in serum
时间窗: 10 years
Difference between pre- and posttreatment level; unit: mM
次要结局
- Change in Body Weight From Baseline(2, 5 & 10 years)
- Bone mineral density (T-score)(10 years)
- Serum Insulin Concentration(2, 5 & 10 years)
- Glycated Hemoglobin (HbA1c)(2, 5 & 10 years)
- Plasma Glucose Concentration(2, 5 & 10 years)
- Change in Body Mass Index (BMI)(2, 5 & 10 years)
- Bone mineral density (BMD)(10 years)
- Bone mineral density (Z-score)(10 years)
- Arterial blood pressure(2, 5 & 10 years)
- Quality of Life(2, 5 & 10 years)
