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NCT Number: NCT03152617

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Gothenburg, SE41345, Sweden

Location status: Recruiting

Location contact

Lars Fandriks, M.D., PhD.

CONTACT

[email protected]

+46313424123

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ionized Calcium in serum

    Time frame: 10 years

    Difference between pre- and posttreatment level; unit: mM

Secondary outcomes

  1. Bone mineral density (BMD)

    Time frame: 10 years

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

  2. Bone mineral density (T-score)

    Time frame: 10 years

    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

  3. Bone mineral density (Z-score)

    Time frame: 10 years

    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

  4. Arterial blood pressure

    Time frame: 2, 5 & 10 years

    arterial systolic and diastolic pressure at rest; mmHg

  5. Quality of Life

    Time frame: 2, 5 & 10 years

    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.

  6. Plasma Glucose Concentration

    Time frame: 2, 5 & 10 years

    Fasting value; unit: mM

  7. Serum Insulin Concentration

    Time frame: 2, 5 & 10 years

    Fasting value; unit: mIE/L

  8. Glycated Hemoglobin (HbA1c)

    Time frame: 2, 5 & 10 years

    Unit: mmol/mol

  9. Change in Body Weight From Baseline

    Time frame: 2, 5 & 10 years

    kg

  10. Change in Body Mass Index (BMI)

    Time frame: 2, 5 & 10 years

    kg x m2

Other outcomes

  1. Nutritional status

    Time frame: 2, 5 & 10 years

    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. Psychomorbidity1: Depression

    Time frame: 2, 5 & 10 years

    Patient Health Questionnaire 9 (PHQ-9); reported value: number of (or percentage) patients reporting scores indicating a moderate to severe depressive state

  3. Psychomorbidity2: Anxiety

    Time frame: 2, 5 & 10 years

    Beck Anxiety Inventory (BAI); reported value: number of (or percentage) patients reporting high scores indicating moderate to severe anxiety

  4. Psychomorbidity3: Adult ADHD

    Time frame: 2, 5 & 10 years

    Adult ADHD Self-Report Scale -Screener (ASRS); reported value: number (or percentage) of patients reporting scores above cut-off indicating adult ADHD symptoms

  5. Psychomorbidity4: Drug use

    Time frame: 2, 5 & 10 years

    Drug Use Disorders Identification Test (DUDIT); reported value: number (or percentage) of patients reporting scores above cut-off indicating risk for drug-related problems

  6. Psychomorbidity5: Alcohol

    Time frame: 2, 5 & 10 years

    Alcohol Use Disorders Identification Test (AUDIT); reported value: number (or percentage) of patients reporting scores above cut-off indicating risk for alcohol-related problems

  7. Gastrointestinal symptomatology

    Time frame: 2, 5 & 10 years

    Rome III Diagnostic criteria; reported value: number (or percentage) of patients fulfilling the criteria for functional gastrointestinal gastrointestinal disorder

  8. Oral Health questionnaire

    Time frame: 2, 5 & 10 years

    Oral Health Impact Profile (OHIP-14); reported value: number (or percentage) of patients scoring above cut-off for oral health impacting quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Fandriks, M.D., PhD.

CONTACT

[email protected]

+46313424123

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Acronym: BASUN

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
May 15, 2017
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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