An observational study in Obesity, Morbid, sponsored by Göteborg University. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Göteborg University · Observational
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.
All patients eligible for obesity treatment under specialist care with medical methods or with surgery are asked for participation.
Exclusion Criteria:
Ionized 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
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
Nutritional status
Blood biochemistry package: Retinol, RBP, Vitamins B, Vid D, methylmalonate, homocysteine, hemoglobulin, MCV, MCH, MCHC, reticulocytes, iron, transferrin, ferritin , Zn, S-Albumin, creatinine, blood lipid profile, ALP; reported value will be number of patients with one or more abnormal laboratory value(-s).
Time frame: 2, 5 & 10 years
Psychomorbidity1: Depression
Patient Health Questionnaire 9 (PHQ-9); reported value: number of (or percentage) patients reporting scores indicating a moderate to severe depressive state
Time frame: 2, 5 & 10 years
Psychomorbidity2: Anxiety
Beck Anxiety Inventory (BAI); reported value: number of (or percentage) patients reporting high scores indicating moderate to severe anxiety
Time frame: 2, 5 & 10 years
Psychomorbidity3: Adult ADHD
Adult ADHD Self-Report Scale -Screener (ASRS); reported value: number (or percentage) of patients reporting scores above cut-off indicating adult ADHD symptoms
Time frame: 2, 5 & 10 years
Psychomorbidity4: Drug use
Drug Use Disorders Identification Test (DUDIT); reported value: number (or percentage) of patients reporting scores above cut-off indicating risk for drug-related problems
Time frame: 2, 5 & 10 years
Psychomorbidity5: Alcohol
Alcohol Use Disorders Identification Test (AUDIT); reported value: number (or percentage) of patients reporting scores above cut-off indicating risk for alcohol-related problems
Time frame: 2, 5 & 10 years
Gastrointestinal symptomatology
Rome III Diagnostic criteria; reported value: number (or percentage) of patients fulfilling the criteria for functional gastrointestinal gastrointestinal disorder
Time frame: 2, 5 & 10 years
Oral Health questionnaire
Oral Health Impact Profile (OHIP-14); reported value: number (or percentage) of patients scoring above cut-off for oral health impacting quality of life.
Time frame: 2, 5 & 10 years
Plan to share: No
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Göteborg University