The Bialystok Bariatric Surgery Study

NCT ID: NCT04634591

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-10

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Diabetes Mellitus Metabolic Syndrome Dyslipidemias PreDiabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Obesity - undergoing bariatric surgery

Patients with morbid obesity, treated with the bariatric surgery

Bariatric surgery

Intervention Type PROCEDURE

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

Obesity - without bariatric surgery treatment

Patients with morbid obesity, not treated with the bariatric surgery

No interventions assigned to this group

Non-obese

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

No interventions assigned to this group

Interventions

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Bariatric surgery

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

Intervention Type PROCEDURE

Other Intervention Names

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Metabolic surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Medical University of Bialystok

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Lukasz Szczerbinski, MD, PhD

Role: primary

+48 85 831 81 50

Other Identifiers

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R-I-002/546/2015

Identifier Type: -

Identifier Source: org_study_id

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