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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid

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.

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

• Study Contact: Name: Lars Fandriks, M.D., PhD.; Phone Number: +46313424123; Email: lars.fandriks@gastro.gu.se

Study Locations

• Sweden
  • Göteborg, Sweden, SE41345
    • Recruiting
    • Department of Gastrosurgical R & E, the Sahlgrenska Academy,University of Gothenburg
    • Contact: Lars Fandriks, M.D., PhD.; Phone Number: +46313424123; Email: lars.fandriks@gastro.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ionized Calcium in serum	Difference between pre- and posttreatment level; unit: mM	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density (BMD)	DXA based assessment; units: areal density (g/cm2)	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	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	10 years
Arterial blood pressure	arterial systolic and diastolic pressure at rest; mmHg	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.	2, 5 & 10 years
Plasma Glucose Concentration	Fasting value; unit: mM	2, 5 & 10 years
Serum Insulin Concentration	Fasting value; unit: mIE/L	2, 5 & 10 years
Glycated Hemoglobin (HbA1c)	Unit: mmol/mol	2, 5 & 10 years
Change in Body Weight From Baseline	kg	2, 5 & 10 years
Change in Body Mass Index (BMI)	kg x m2	2, 5 & 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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	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	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	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	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	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.	2, 5 & 10 years

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Lars Fandriks, M.D., PhD., Institute of Clinical Sciences, the Sahlgrenska Academy, University of Gothenburg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: bariatric surgery; malnutrition; oral health; gastric bypass; bone disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Overweight; Malnutrition; Obesity; Obesity, Morbid; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: KMossberg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO