BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment
- Conditions
- Obesity, Morbid
- Registration Number
- NCT03152617
- Lead Sponsor
- Göteborg University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1400
- All patients eligible for obesity treatment under specialist care with medical methods or with surgery
- no ability to speak, read or write in Swedish
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ionized Calcium in serum 10 years Difference between pre- and posttreatment level; unit: mM
- Secondary Outcome Measures
Name Time Method Change in Body Weight From Baseline 2, 5 & 10 years kg
Bone mineral density (T-score) 10 years T-score is bone mineral density (BMD)in relation to young healthy adults of the same sex; unit: number of standard deviations below or above BMD of controls
Serum Insulin Concentration 2, 5 & 10 years Fasting value; unit: mIE/L
Glycated Hemoglobin (HbA1c) 2, 5 & 10 years Unit: mmol/mol
Plasma Glucose Concentration 2, 5 & 10 years Fasting value; unit: mM
Change in Body Mass Index (BMI) 2, 5 & 10 years kg x m2
Bone mineral density (BMD) 10 years DXA based assessment; units: areal density (g/cm2)
Bone mineral density (Z-score) 10 years Z-score is bone mineral density (BMD) in relation adults of the same age; unit: number of standard deviations below or above BMD of controls of the same age
Arterial blood pressure 2, 5 & 10 years arterial systolic and diastolic pressure at rest; mmHg
Quality of Life 2, 5 & 10 years 36-item Short Form Survey(RAND36); Reported value: reported value: number of (or percentage) patients reporting physical and mental health summary scores indicating moderately to severely reduced quality of life as compared to a general reference population.
Trial Locations
- Locations (1)
Department of Gastrosurgical R & E, the Sahlgrenska Academy,University of Gothenburg
🇸🇪Göteborg, Sweden