The Bialystok Bariatric Surgery Study

Study Overview
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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.

Official Title
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The Bialystok Bariatric Surgery Study

Conditions
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Obesity, Diabetes Mellitus, Metabolic Syndrome, Dyslipidemias, PreDiabetes

Intervention / Treatment
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* Procedure: Bariatric surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obesity - undergoing bariatric surgery<br>Patients with morbid obesity, treated with the bariatric surgery | Procedure: Bariatric surgery<br>* Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity<br>* Other names: Metabolic surgery;|
| Obesity - without bariatric surgery treatment<br>Patients with morbid obesity, not treated with the bariatric surgery | |
| Non-obese<br>Non-obese patients - control group (without obesity and without the bariatric surgery treatment) | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, diabetes treatment, prediabetes treatment, metabolic surgery