Observational study on bariatric surgery outcomes
The Bialystok Bariatric Surgery Study
Medical University of Bialystok · NCT04634591
This study looks at how bariatric surgery affects weight loss and related health issues like diabetes in patients over two years after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Bialystok (other) |
| Locations | 1 site (Bialystok, Podlaskie Voivodeship) |
| Trial ID | NCT04634591 on ClinicalTrials.gov |
What this trial studies
The Bialystok Bariatric Surgery Study is a prospective observational cohort study focusing on patients undergoing bariatric surgery at the Medical University of Bialystok. Participants will undergo a series of baseline tests one month prior to surgery, with follow-up assessments at one, three, six, twelve, and twenty-four months post-surgery. The study aims to evaluate the effects of bariatric surgery on obesity and related conditions such as diabetes and metabolic syndrome.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a BMI of 40 or higher, or a BMI of 35 or higher with obesity-related co-morbidities.
Not a fit: Patients with substance abuse issues, uncontrolled psychiatric illnesses, or advanced-stage cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term benefits of bariatric surgery for managing obesity and its associated health conditions.
How similar studies have performed: Other studies have shown positive outcomes with bariatric surgery for obesity and related conditions, indicating that this approach is well-supported in the literature.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bialystok, Podlaskie Voivodeship
- Clinical Research Centre, Medical University of Bialystok — Bialystok, Podlaskie Voivodeship, Poland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Diabetes Mellitus, Metabolic Syndrome, Dyslipidemias, PreDiabetes, bariatric surgery, diabetes treatment, prediabetes treatment