The Bialystok Bariatric Surgery Study (BBSS)

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 Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus; Metabolic Syndrome; Dyslipidemias; PreDiabetes
• Intervention / Treatment: Procedure: Bariatric surgery

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Poland
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-276
      • Recruiting
      • Clinical Research Centre, Medical University of Bialystok
      • Contact: Lukasz Szczerbinski, MD, PhD; Phone Number: +48 85 831 81 50; Email: lukasz.szczerbinski@umb.edu.pl
      • Principal Investigator: Adam Kretowski, Prof., MD, PhD
      • Principal Investigator: Lukasz Szczerbinski, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

In Bialystok Bariatric Surgery Study (BBSS), we observe a cohort study of patients who undergo bariatric surgery in the First Clinical Department of General and Endocrine Surgery of the Medical University of Bialystok. This center performs several types of bariatric surgery including Roux-en-Y gastric bypass (RYGB), adjustable gastric banding (AGB), and sleeve gastrectomy (SG) in patients referred to the clinic by general practitioners and endocrinologists and who were qualified for the surgery according to the clinical physicians. Only patients who agreed to participate in the research project, specified in detail during written and oral patients consent, are included. Moreover, the study population consists of the group of obese patients who do not undergo the surgery and are followed-up without the surgical intervention and the non-obese control group of patients without obesity.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obesity - undergoing bariatric surgery; Patients with morbid obesity, treated with the bariatric surgery	Procedure: Bariatric surgery; Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity; Other Names: Metabolic 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Changes in total body weight under the surgery	1, 3, 6, 12 and 24 months after the surgery
Lean body mass	Changes in total lean body mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)	1, 3, 6, 12 and 24 months after the surgery
Fat mass	Changes in total fat mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)	1, 3, 6, 12 and 24 months after the surgery
Visceral adipose tissue mass	Changes in visceral adipose tissue mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)	1, 3, 6, 12 and 24 months after the surgery
Fasting glucose	Changes in fasting glucose concentration under the surgery, measured in plasma using the colorimetric method	1, 3, 6, 12 and 24 months after the surgery
Triglycerides (TG)	Changes in serum triglycerides concentration under the surgery, measured using the colorimetric method	1, 3, 6, 12 and 24 months after the surgery
High-density lipoprotein cholesterol (HDL)	Changes in serum High-density lipoprotein cholesterol (HDL) concentration under the surgery, measured using the colorimetric method	1, 3, 6, 12 and 24 months after the surgery
Low-density lipoprotein cholesterol (LDL)	Changes in serum Low-density lipoprotein cholesterol (LDL) concentration under the surgery, measured using the colorimetric method	1, 3, 6, 12 and 24 months after the surgery
Total cholesterol	Changes in serum total cholesterol concentration under the surgery, measured using the colorimetric method	1, 3, 6, 12 and 24 months after the surgery
Fasting insulin	Changes in fasting insulin concentration under the surgery, measured by the immunoradiometric assay (IRMA)	1, 3, 6, 12 and 24 months after the surgery
2-hour glucose	Changes in glucose concentration at 2-hour of the oral glucose tolerance test under the surgery, measured in plasma using the colorimetric method	1, 3, 6, 12 and 24 months after the surgery
Haemoglobin A1c (HbA1c)	Changes in Haemoglobin A1c under the surgery, measured by the high-performance liquid chromatography (HPLC) method	1, 3, 6, 12 and 24 months after the surgery
Homeostatic model assessment for insulin resistance (HOMA-IR)	Changes in Homeostatic model assessment for insulin resistance under the surgery	1, 3, 6, 12 and 24 months after the surgery
Homeostatic model assessment of beta cell function (HOMA-beta)	Changes in Homeostatic model assessment of beta cell function under the surgery	1, 3, 6, 12 and 24 months after the surgery
Changes in glucose and insulin concentrations during the oral glucose tolerance test (OGTT)	Changes in concentrations of glucose and insulin during the oral glucose tolerance test, under the surgery	1, 3, 6, 12 and 24 months after the surgery
Changes in glucose and insulin concentrations during the mixed meal tolerance test (MMTT)	Changes in concentrations of glucose and insulin during the mixed meal tolerance test, under the surgery	1, 3, 6, 12 and 24 months after the surgery
Changes in GI hormones concentrations during the oral glucose tolerance test (OGTT)	Changes in concentrations of gastrointestinal hormones during the oral glucose tolerance test, under the surgery	1, 3, 6, 12 and 24 months after the surgery
Changes in GI hormones concentrations during the mixed meal tolerance test (MMTT)	Changes in concentrations of gastrointestinal hormones during the mixed meal tolerance test, under the surgery	1, 3, 6, 12 and 24 months after the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2015
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: bariatric surgery; metabolic surgery; diabetes treatment; prediabetes treatment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Lipid Metabolism Disorders; Metabolic Syndrome; Prediabetic State; Glucose Intolerance; Dyslipidemias
• Other Study ID Numbers: R-I-002/546/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No