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

Sponsor

Göteborg University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03152617

Collaborator

(none)

1,400

Enrollment

Location

152

Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Apr 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

Ionized Calcium in serum [10 years]
Difference between pre- and posttreatment level; unit: mM

Secondary Outcome Measures

Bone mineral density (BMD) [10 years]
DXA based assessment; units: areal density (g/cm2)
Bone mineral density (T-score) [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) [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 [2, 5 & 10 years]
arterial systolic and diastolic pressure at rest; mmHg
Quality of Life [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 [2, 5 & 10 years]
Fasting value; unit: mM
Serum Insulin Concentration [2, 5 & 10 years]
Fasting value; unit: mIE/L
Glycated Hemoglobin (HbA1c) [2, 5 & 10 years]
Unit: mmol/mol
Change in Body Weight From Baseline [2, 5 & 10 years]
kg
Change in Body Mass Index (BMI) [2, 5 & 10 years]
kg x m2

Other Outcome Measures

Nutritional status [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 [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 [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 [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 [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 [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 [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 [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.