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

Overview

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.

Primary outcome measures

• Ionized Calcium in serum [Time frame: 10 years]

Secondary outcome measures (10)

• Bone mineral density (BMD) [Time frame: 10 years]
• Bone mineral density (T-score) [Time frame: 10 years]
• Bone mineral density (Z-score) [Time frame: 10 years]
• Arterial blood pressure [Time frame: 2, 5 & 10 years]
• Quality of Life [Time frame: 2, 5 & 10 years]
• Plasma Glucose Concentration [Time frame: 2, 5 & 10 years]
• Serum Insulin Concentration [Time frame: 2, 5 & 10 years]
• Glycated Hemoglobin (HbA1c) [Time frame: 2, 5 & 10 years]
• Change in Body Weight From Baseline [Time frame: 2, 5 & 10 years]
• Change in Body Mass Index (BMI) [Time frame: 2, 5 & 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Sweden · 1 center

• Department of Gastrosurgical R & E, the Sahlgrenska Academy,University of Gothenburg — Gothenburg

Publications

• Celander J, Engstrom M, Hoskuldsdottir G, Lener F, Simons K, Wallenius V, Eliasson B, Hedberg S, Mossberg K. Anaemia and weight outcomes 5 years after metabolic and bariatric surgery - a prospective cohort study. Nutr Metab Cardiovasc Dis. 2026 Apr;36(4):104521. doi: 10.1016/j.numecd.2025.104521. Epub 2025 Dec 11. PMID 41486025
• Taghat N, Mossberg K, Lingstrom P, Petzold M, Ostberg AL. Impact of Medical and Surgical Obesity Treatment on Dental Caries: A 2-Year Prospective Cohort Study. Caries Res. 2023;57(3):231-242. doi: 10.1159/000533609. Epub 2023 Aug 16. PMID 37586350
• Lener F, Hoskuldsdottir G, Landin-Wilhelmsen K, Bjorkelund C, Eliasson B, Fandriks L, Wallenius V, Engstrom M, Mossberg K. Anaemia in patients with self-reported use of iron supplements in the BAriatric surgery SUbstitution and nutrition study: A prospective cohort study. Nutr Metab Cardiovasc Dis. 2023 May;33(5):998-1006. doi: 10.1016/j.numecd.2023.02.008. Epub 2023 Feb 16. PMID 36890072
• 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. PMID 35876084
• 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. PMID 35396282
• 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. PMID 34507573
• 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. PMID 32059719

Identifiers

NCT: NCT03152617 · KMossberg

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗