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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Obesity, Morbid

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, gastric bypass, malnutrition, bone disease, oral health