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Recruiting NCT04634591

The Bialystok Bariatric Surgery Study

— Observational Obesity Diabetes Mellitus Metabolic Syndrome Dyslipidemias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bariatric surgery.
Who it may be relevant to
Registry conditions: Obesity, Diabetes Mellitus, Metabolic Syndrome, Dyslipidemias. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Weight loss [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Lean body mass [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Fat mass [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Visceral adipose tissue mass [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Fasting glucose [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Triglycerides (TG) [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • High-density lipoprotein cholesterol (HDL) [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Low-density lipoprotein cholesterol (LDL) [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Total cholesterol [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Fasting insulin [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
Secondary outcome measures (10)
  • Plasma metabolome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Plasma proteome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Urine metabolome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Skeletal muscle transcriptome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Liver transcriptome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Adipose tissue transcriptome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Circulating microRNA [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Liver methylome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Skeletal muscle methylome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]
  • Adipose tissue methylome [Time frame: 1, 3, 6, 12 and 24 months after the surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Poland · 1 center
  • Clinical Research Centre, Medical University of Bialystok — Bialystok

Identifiers

NCT: NCT04634591 · R-I-002/546/2015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗