BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment (BASUN)
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|ClinicalTrials.gov Identifier: NCT03152617|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : September 19, 2019
|Condition or disease|
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 [Patient Registry]|
|Estimated Enrollment :||1400 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment - Interaction With Gastrointestinal Microbiota, Psychiatric Morbidity and Socioeconomics|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2027|
|Estimated Study Completion Date :||December 2027|
- Ionized Calcium in serum [ Time Frame: 10 years ]Difference between pre- and posttreatment level; unit: mM
- Bone mineral density (BMD) [ Time Frame: 10 years ]DXA based assessment; units: areal density (g/cm2)
- 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
- 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
- Arterial blood pressure [ Time Frame: 2, 5 & 10 years ]arterial systolic and diastolic pressure at rest; mmHg
- 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.
- Plasma Glucose Concentration [ Time Frame: 2, 5 & 10 years ]Fasting value; unit: mM
- Serum Insulin Concentration [ Time Frame: 2, 5 & 10 years ]Fasting value; unit: mIE/L
- Glycated Hemoglobin (HbA1c) [ Time Frame: 2, 5 & 10 years ]Unit: mmol/mol
- Change in Body Weight From Baseline [ Time Frame: 2, 5 & 10 years ]kg
- Change in Body Mass Index (BMI) [ Time Frame: 2, 5 & 10 years ]kg x m2
- 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).
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152617
|Contact: Lars Fandriks, M.D., PhD.||+firstname.lastname@example.org|
|Department of Gastrosurgical R & E, the Sahlgrenska Academy,University of Gothenburg||Recruiting|
|Göteborg, Sweden, SE41345|
|Contact: Lars Fandriks, M.D., PhD. +46313424123 email@example.com|
|Principal Investigator:||Lars Fandriks, M.D., PhD.||Institute of Clinical Sciences, the Sahlgrenska Academy, University of Gothenburg|