The Bialystok Bariatric Surgery Study (BBSS)

Medical University of Bialystok

Status: Enrolling

Conditions: Dyslipidemias; Diabetes Mellitus; Obesity; PreDiabetes; Metabolic Syndrome

Treatments: Procedure: Bariatric surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04634591

R-I-002/546/2015

Details and patient eligibility

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,000 participants in 3 patient groups

Obesity - undergoing bariatric surgery

Description:

Patients with morbid obesity, treated with the bariatric surgery

Treatment:

Procedure: Bariatric surgery

Obesity - without bariatric surgery treatment

Description:

Patients with morbid obesity, not treated with the bariatric surgery

Non-obese

Description:

Non-obese patients - control group (without obesity and without the bariatric surgery treatment)