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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Non-obese control group:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre, Medical University of Bialystok | Recruiting | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| D050171 | Dyslipidemias |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 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 |
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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D052439 | Lipid Metabolism Disorders |