The Bialystok Bariatric Surgery Study

ConditionsObesity Diabetes Mellitus Metabolic Syndrome Dyslipidemias PreDiabetes

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMedical University of Bialystok

About this trial

The Bialystok Bariatric Surgery Study (BBSS) is a prospective observational cohort study of patients undergoing bariatric surgery at the First Clinical Department of General and Endocrine Surgery at the Medical University of Bialystok. The BBSS consists of a battery of baseline tests established one month prior to the surgery and repeated at one, three, six, twelve and twenty four-month follow-up clinical visits.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI ≥ 40 kg/m2, or BMI ≥ 35 and at least one or more obesity-related co-morbidities such as type 2 diabetes (T2D), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.

Inability to achieve a healthy weight loss sustained for a period of time with prior weight loss efforts

Patient consent for participation in research project

Willingness in participation in follow-up visits

Disqualifiers

substance abuse,

uncontrolled psychiatric illness

expected lack of compliance

advanced-stage cancer

Trial population

In Bialystok Bariatric Surgery Study (BBSS), we observe a cohort study of patients who undergo bariatric surgery in the First Clinical Department of General and Endocrine Surgery of the Medical University of Bialystok. This center performs several types of bariatric surgery including Roux-en-Y gastric bypass (RYGB), adjustable gastric banding (AGB), and sleeve gastrectomy (SG) in patients referred to the clinic by general practitioners and endocrinologists and who were qualified for the surgery according to the clinical physicians. Only patients who agreed to participate in the research project, specified in detail during written and oral patients consent, are included. Moreover, the study population consists of the group of obese patients who do not undergo the surgery and are followed-up without the surgical intervention and the non-obese control group of patients without obesity.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Bariatric surgery
Procedure/Surgery
Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity

Treatment groups

1,000 Participants

are divided into 3 treatment groups

Group A: Obesity - undergoing bariatric surgery1 intervention

Group B: Obesity - without bariatric surgery treatment0 interventions

Group C: Non-obese0 interventions

Trial outcomes