BASUN - Risks for Malnutrition, Metabolic Bone Disease & Impaired Oral

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03152617
Study type	Observational [Patient Registry]
Source	Göteborg University
Contact	Lars Fandriks, M.D., PhD.
Phone	+46313424123
Email	lars.fandriks@gastro.gu.se
Status	Recruiting
Phase
Start date	April 2015
Completion date	December 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms