Clinical trial NCT03152617: BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment
Official title: BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment - Interaction With Gastrointestinal Microbiota, Psychiatric Morbidity and Socioeconomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: bariatric surgery
gastric bypass
malnutrition
bone disease
oral health
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients eligible for obesity treatment under specialist care with medical methods or with surgery are asked for participation.

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.

Eligibility criteria: Inclusion Criteria:

* All patients eligible for obesity treatment under specialist care with medical methods or with surgery

Exclusion Criteria:

* no ability to speak, read or write in Swedish

Primary outcomes:
measure: Ionized Calcium in serum
timeFrame: 10 years
Secondary outcomes:
measure: Bone mineral density (BMD)
timeFrame: 10 years
measure: Bone mineral density (T-score)
timeFrame: 10 years
measure: Bone mineral density (Z-score)
timeFrame: 10 years
measure: Arterial blood pressure
timeFrame: 2, 5 & 10 years
measure: Quality of Life
timeFrame: 2, 5 & 10 years
measure: Plasma Glucose Concentration
timeFrame: 2, 5 & 10 years
measure: Serum Insulin Concentration
timeFrame: 2, 5 & 10 years
measure: Glycated Hemoglobin (HbA1c)
timeFrame: 2, 5 & 10 years
measure: Change in Body Weight From Baseline
timeFrame: 2, 5 & 10 years
measure: Change in Body Mass Index (BMI)
timeFrame: 2, 5 & 10 years
Other outcomes:
measure: Nutritional status
timeFrame: 2, 5 & 10 years
measure: Psychomorbidity1: Depression
timeFrame: 2, 5 & 10 years
measure: Psychomorbidity2: Anxiety
timeFrame: 2, 5 & 10 years
measure: Psychomorbidity3: Adult ADHD
timeFrame: 2, 5 & 10 years
measure: Psychomorbidity4: Drug use
timeFrame: 2, 5 & 10 years
measure: Psychomorbidity5: Alcohol
timeFrame: 2, 5 & 10 years
measure: Gastrointestinal symptomatology
timeFrame: 2, 5 & 10 years
measure: Oral Health questionnaire
timeFrame: 2, 5 & 10 years
Locations:
city: Göteborg
country: Sweden
facility: Department of Gastrosurgical R & E, the Sahlgrenska Academy,University of Gothenburg
Study officials:
affiliation: Institute of Clinical Sciences, the Sahlgrenska Academy, University of Gothenburg
name: Lars Fandriks, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taghat N, Lingstrom P, Mossberg K, Fandriks L, Eliasson B, Ostberg AL. Oral health by obesity classification in young obese women - a cross-sectional study. Acta Odontol Scand. 2022 Nov;80(8):596-604. doi: 10.1080/00016357.2022.2063942. Epub 2022 Jul 24.
citation: Hoskuldsdottir G, Engstrom M, Rawshani A, Lener F, Wallenius V, Fandriks L, Mossberg K, Eliasson B. Comparing effects of obesity treatment with very low energy diet and bariatric surgery after 2 years: a prospective cohort study. BMJ Open. 2022 Apr 8;12(4):e053242. doi: 10.1136/bmjopen-2021-053242.
citation: Hoskuldsdottir G, Engstrom M, Rawshani A, Wallenius V, Lener F, Fandriks L, Mossberg K, Eliasson B. The BAriatic surgery SUbstitution and nutrition (BASUN) population: a data-driven exploration of predictors for obesity. BMC Endocr Disord. 2021 Sep 10;21(1):183. doi: 10.1186/s12902-021-00849-9.
citation: Hoskuldsdottir G, Mossberg K, Wallenius V, Al Nimer A, Bjorkvall W, Lundberg S, Behre CJ, Werling M, Eliasson B, Fandriks L. Design and baseline data in the BAriatic surgery SUbstitution and Nutrition study (BASUN): a 10-year prospective cohort study. BMC Endocr Disord. 2020 Feb 14;20(1):23. doi: 10.1186/s12902-020-0503-z.