跳至主要内容
临床试验/NCT03152617
NCT03152617招募中不适用

BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment - Interaction With Gastrointestinal Microbiota, Psychiatric Morbidity and Socioeconomics

Göteborg University1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2015年4月最近更新:
适应症

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

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)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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