The Bialystok Bariatric Surgery Study

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2023

Interventions

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

Arms, Groups and Cohorts

  • Obesity – undergoing bariatric surgery
    • Patients with morbid obesity, treated with the bariatric surgery
  • Obesity – without bariatric surgery treatment
    • Patients with morbid obesity, not treated with the bariatric surgery
  • Non-obese
    • Non-obese patients – control group (without obesity and without the bariatric surgery treatment)

Clinical Trial Outcome Measures

Primary Measures

  • Weight loss
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in total body weight under the surgery
  • Lean body mass
    • Time Frame: 1, 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 mass
    • Time Frame: 1, 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 mass
    • Time Frame: 1, 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 glucose
    • Time Frame: 1, 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
  • Total cholesterol
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in serum total cholesterol concentration under the surgery, measured using the colorimetric method
  • Fasting insulin
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in fasting insulin concentration under the surgery, measured by the immunoradiometric assay (IRMA)
  • 2-hour glucose
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in glucose concentration at 2-hour of the oral glucose tolerance test under the surgery, measured in plasma using the colorimetric method
  • Haemoglobin A1c (HbA1c)
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in Haemoglobin A1c under the surgery, measured by the high-performance liquid chromatography (HPLC) method
  • Homeostatic model assessment for insulin resistance (HOMA-IR)
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in Homeostatic model assessment for insulin resistance under the surgery
  • Homeostatic model assessment of beta cell function (HOMA-beta)
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in Homeostatic model assessment of beta cell function under the surgery
  • Changes in glucose and insulin concentrations during the oral glucose tolerance test (OGTT)
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in concentrations of glucose and insulin during the oral glucose tolerance test, under the surgery
  • Changes in glucose and insulin concentrations during the mixed meal tolerance test (MMTT)
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in concentrations of glucose and insulin during the mixed meal tolerance test, under the surgery
  • Changes in GI hormones concentrations during the oral glucose tolerance test (OGTT)
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in concentrations of gastrointestinal hormones during the oral glucose tolerance test, under the surgery
  • Changes in GI hormones concentrations during the mixed meal tolerance test (MMTT)
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in concentrations of gastrointestinal hormones during the mixed meal tolerance test, under the surgery

Secondary Measures

  • Plasma metabolome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in plasma metabolites concentrations measured using untargeted metabolomics, in response to the surgery
  • Plasma proteome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in plasma proteins concentrations measured using targeted and untargeted proteomics, in response to the surgery
  • Urine metabolome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in urine metabolites concentrations measured using untargeted metabolomics, in response to the surgery
  • Skeletal muscle transcriptome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in skeletal muscle gene and small RNA expressions measured using untargeted transcriptomics, in response to the surgery
  • Liver transcriptome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in liver gene and small RNA expressions measured using untargeted transcriptomics, in response to the surgery
  • Adipose tissue transcriptome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in adipose tissue gene and small RNA expressions measured using untargeted transcriptomics, in response to the surgery
  • Circulating microRNA
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in circulating microRNAs expression, in response to the surgery
  • Liver methylome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in liver DNA methylations measured using Reduced representation bisulfite sequencing (RRBS) method, in response to the surgery
  • Skeletal muscle methylome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in skeletal muscle DNA methylations measured using Reduced representation bisulfite sequencing (RRBS) method, in response to the surgery
  • Adipose tissue methylome
    • Time Frame: 1, 3, 6, 12 and 24 months after the surgery
    • Changes in adipose tissue DNA methylations measured using Reduced representation bisulfite sequencing (RRBS) method, in response to the surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Bialystok
  • Collaborator
    • University of Copenhagen
  • Provider of Information About this Clinical Study
    • Sponsor

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