BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment

NCT03152617 | Recruiting

• 1 other identifier: KMossberg
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Keywords

bariatric surgery; gastric bypass; malnutrition; bone disease; oral health

Outcome Measures

Primary Outcomes (1)

• Ionized Calcium in serum

  Difference between pre- and posttreatment level; unit: mM

  10 years

Secondary Outcomes (10)

• Bone mineral density (BMD)

  10 years

• Bone mineral density (T-score)

  10 years

• Bone mineral density (Z-score)

  10 years

• Arterial blood pressure

  2, 5 & 10 years

• Quality of Life

  2, 5 & 10 years

Other Outcomes (8)

• Nutritional status

  2, 5 & 10 years

• Psychomorbidity1: Depression

  2, 5 & 10 years

• Psychomorbidity2: Anxiety

  2, 5 & 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• no ability to speak, read or write in Swedish

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

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

Gothenburg, SE41345, Sweden

RECRUITING

Related Publications (7)

• 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. 2025 Dec 11:104521. doi: 10.1016/j.numecd.2025.104521. Online ahead of print.

  PMID: 41486025 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Obesity, Morbid; Malnutrition; Bone Diseases

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases

Study Officials

• Lars Fandriks, M.D., PhD.

  Institute of Clinical Sciences, the Sahlgrenska Academy, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Fandriks, M.D., PhD.

CONTACT

+46313424123; lars.fandriks@gastro.gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: May 15, 2017
• Study Start: April 1, 2015
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)