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

Obesity, Morbid Clinical Trial

— BASUN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152617
• Other study ID #: MWerling
• Status: Recruiting
• Start date: April 2015
• Est. completion date: December 2027

Study information

• Verified date: September 2019
• Source: Göteborg University
• Contact: Lars Fandriks, M.D., PhD.
• Phone: +46313424123
• Email: lars.fandriks[@]gastro.gu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Malnutrition
• Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Sweden	Department of Gastrosurgical R & E, the Sahlgrenska Academy,University of Gothenburg	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	2, 5 & 10 years
Other	Psychomorbidity1: Depression	Patient Health Questionnaire 9 (PHQ-9); reported value: number of (or percentage) patients reporting scores indicating a moderate to severe depressive state	2, 5 & 10 years
Other	Psychomorbidity2: Anxiety	Beck Anxiety Inventory (BAI); reported value: number of (or percentage) patients reporting high scores indicating moderate to severe anxiety	2, 5 & 10 years
Other	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	2, 5 & 10 years
Other	Psychomorbidity4: Drug use	Drug Use Disorders Identification Test (DUDIT); reported value: number (or percentage) of patients reporting scores above cut-off indicating risk for drug-related problems	2, 5 & 10 years
Other	Psychomorbidity5: Alcohol	Alcohol Use Disorders Identification Test (AUDIT); reported value: number (or percentage) of patients reporting scores above cut-off indicating risk for alcohol-related problems	2, 5 & 10 years
Other	Gastrointestinal symptomatology	Rome III Diagnostic criteria; reported value: number (or percentage) of patients fulfilling the criteria for functional gastrointestinal gastrointestinal disorder	2, 5 & 10 years
Other	Oral Health questionnaire	Oral Health Impact Profile (OHIP-14); reported value: number (or percentage) of patients scoring above cut-off for oral health impacting quality of life.	2, 5 & 10 years
Primary	Ionized Calcium in serum	Difference between pre- and posttreatment level; unit: mM	10 years
Secondary	Bone mineral density (BMD)	DXA based assessment; units: areal density (g/cm2)	10 years
Secondary	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
Secondary	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
Secondary	Arterial blood pressure	arterial systolic and diastolic pressure at rest; mmHg	2, 5 & 10 years
Secondary	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
Secondary	Plasma Glucose Concentration	Fasting value; unit: mM	2, 5 & 10 years
Secondary	Serum Insulin Concentration	Fasting value; unit: mIE/L	2, 5 & 10 years
Secondary	Glycated Hemoglobin (HbA1c)	Unit: mmol/mol	2, 5 & 10 years
Secondary	Change in Body Weight From Baseline	kg	2, 5 & 10 years
Secondary	Change in Body Mass Index (BMI)	kg x m2	2, 5 & 10 years