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Obesity, MorbidBASUNNCT03152617

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

An observational study of Obesity, Morbid, run by Göteborg University at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Morbid
How many people
1,400 participants
Where
1 siteSweden
Study dates
Apr 2015to Dec 2027
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients eligible for obesity treatment under specialist care with medical methods or with surgery are asked for participation.

Who may be able to join

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

Who cannot join

  • no ability to speak, read or write in Swedish

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lars Fandriks, M.D., PhD. contact

+46313424123

lars.fandriks@gastro.gu.se

Sweden1 site, 1 recruiting

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

    Gothenburg, SE41345

    Lars Fandriks, M.D., PhD., +46313424123, lars.fandriks@gastro.gu.se

    Recruiting

Other trials in Sweden

About this study

Official title: BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment - Interaction With Gastrointestinal Microbiota, Psychiatric Morbidity and Socioeconomics

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.

Read the 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.

Conditions
Obesity, Morbid
Keywords
bariatric surgery, gastric bypass, malnutrition, bone disease, oral health
Medical subject headings
Obesity, Morbid, Malnutrition, Bone Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ionized Calcium in serum

    Difference between pre- and posttreatment level; unit: mM

    Measured: 10 years

Secondary outcomes (10)

  1. Bone mineral density (BMD)

    DXA based assessment; units: areal density (g/cm2)

    Measured: 10 years

  2. 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

    Measured: 10 years

  3. 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

    Measured: 10 years

  4. Arterial blood pressure

    arterial systolic and diastolic pressure at rest; mmHg

    Measured: 2, 5 & 10 years

  5. 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.

    Measured: 2, 5 & 10 years

  6. Plasma Glucose Concentration

    Fasting value; unit: mM

    Measured: 2, 5 & 10 years

  7. Serum Insulin Concentration

    Fasting value; unit: mIE/L

    Measured: 2, 5 & 10 years

  8. Glycated Hemoglobin (HbA1c)

    Unit: mmol/mol

    Measured: 2, 5 & 10 years

  9. Change in Body Weight From Baseline

    kg

    Measured: 2, 5 & 10 years

  10. Change in Body Mass Index (BMI)

    kg x m2

    Measured: 2, 5 & 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study startApr 2015
  3. Primary completionApr 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,400 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03152617
Sponsor's protocol ID
KMossberg
Acronym
BASUN
Status last verified
Apr 2025
First submitted
3 Oct 2016
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32059719

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Morbid, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lars Fandriks, M.D., PhD. (+46313424123, lars.fandriks@gastro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ionized Calcium in serum (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03152617, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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