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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,400
Department of Gastrosurgical R & E, the Sahlgrenska Academy,University of Gothenburg
Gothenburg, Sweden
RECRUITINGIonized Calcium in serum
Difference between pre- and posttreatment level; unit: mM
Time frame: 10 years
Bone mineral density (BMD)
DXA based assessment; units: areal density (g/cm2)
Time frame: 10 years
Bone mineral density (T-score)
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
Time frame: 10 years
Bone mineral density (Z-score)
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
Time frame: 10 years
Arterial blood pressure
arterial systolic and diastolic pressure at rest; mmHg
Time frame: 2, 5 & 10 years
Quality of Life
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.
Time frame: 2, 5 & 10 years
Plasma Glucose Concentration
Fasting value; unit: mM
Time frame: 2, 5 & 10 years
Serum Insulin Concentration
Fasting value; unit: mIE/L
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Time frame: 2, 5 & 10 years
Glycated Hemoglobin (HbA1c)
Unit: mmol/mol
Time frame: 2, 5 & 10 years
Change in Body Weight From Baseline
kg
Time frame: 2, 5 & 10 years
Change in Body Mass Index (BMI)
kg x m2
Time frame: 2, 5 & 10 years