Clinical trial

The Bialystok Bariatric Surgery Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT04634591

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionObesity, Diabetes Mellitus, Metabolic Syndrome, Dyslipidemias, PreDiabetes

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * substance abuse, * uncontrolled psychiatric illness * expected lack of compliance * advanced-stage cancer Non-obese control group: * BMI \<30

Treatments and study arms

Bariatric surgery

Procedure

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

Primary outcomes

Weight loss1, 3, 6, 12 and 24 months after the surgery

Changes in total body weight under the surgery

Lean body mass1, 3, 6, 12 and 24 months after the surgery

Changes in total lean body mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)

Fat mass1, 3, 6, 12 and 24 months after the surgery

Changes in total fat mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)

Visceral adipose tissue mass1, 3, 6, 12 and 24 months after the surgery

Changes in visceral adipose tissue mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)

Fasting glucose1, 3, 6, 12 and 24 months after the surgery

Changes in fasting glucose concentration under the surgery, measured in plasma using the colorimetric method

Triglycerides (TG)1, 3, 6, 12 and 24 months after the surgery

Changes in serum triglycerides concentration under the surgery, measured using the colorimetric method

High-density lipoprotein cholesterol (HDL)1, 3, 6, 12 and 24 months after the surgery

Changes in serum High-density lipoprotein cholesterol (HDL) concentration under the surgery, measured using the colorimetric method

Low-density lipoprotein cholesterol (LDL)1, 3, 6, 12 and 24 months after the surgery

Changes in serum Low-density lipoprotein cholesterol (LDL) concentration under the surgery, measured using the colorimetric method

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Clinical Research Centre, Medical University of Bialystok🇵🇱 Bialystok, Podlaskie Voivodeship, Poland

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Lukasz Szczerbinski, MD, PhDContact

Email · Call +48 85 831 81 50

Adam Kretowski, Prof., MD, PhDPrincipal Investigator

Lukasz Szczerbinski, MD, PhDPrincipal Investigator