BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment
ConditionObesity, Morbid
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGöteborg University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients eligible for obesity treatment under specialist care with medical methods or with surgery
Disqualifiers
no ability to speak, read or write in Swedish
Trial population
All patients eligible for obesity treatment under specialist care with medical methods or with surgery are asked for participation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Ionized Calcium in serum
Difference between pre- and posttreatment level; unit: mM
Time frame
10 yearsSecondary outcomes
1
Bone mineral density (BMD)
DXA based assessment; units: areal density (g/cm2)
Time frame
10 years2
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
Time frame
10 years3
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
Time frame
10 years4
Arterial blood pressure
arterial systolic and diastolic pressure at rest; mmHg
Time frame
2, 5 & 10 yearsOther outcomes
1
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).
Time frame
2, 5 & 10 years2
Psychomorbidity1: Depression
Patient Health Questionnaire 9 (PHQ-9); reported value: number of (or percentage) patients reporting scores indicating a moderate to severe depressive state
Time frame
2, 5 & 10 years3
Psychomorbidity2: Anxiety
Beck Anxiety Inventory (BAI); reported value: number of (or percentage) patients reporting high scores indicating moderate to severe anxiety
Time frame
2, 5 & 10 years4
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
Time frame
2, 5 & 10 yearsSponsors and contacts
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Source ClinicalTrials.gov