The Bialystok Bariatric Surgery Study

Medical University of Bialystok1,000 enrolled

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

OBSERVATIONAL

Enrollment

1,000

Conditions

Obesity Diabetes Mellitus Metabolic Syndrome Dyslipidemias PreDiabetes

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, Poland

RECRUITING

Outcomes

Primary Outcomes

Weight loss

Changes in total body weight under the surgery

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1, 3, 6, 12 and 24 months after the surgery

Secondary Outcomes

Plasma metabolome

Changes in plasma metabolites concentrations measured using untargeted metabolomics, in response to the surgery

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1, 3, 6, 12 and 24 months after the surgery

Circulating microRNA

Changes in circulating microRNAs expression, in response to the surgery

Time frame: 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

Data from ClinicalTrials.gov

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Skeletal muscle methylome

Changes in skeletal muscle DNA methylations measured using Reduced representation bisulfite sequencing (RRBS) method, in response to the surgery

Time frame: 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

Time frame: 1, 3, 6, 12 and 24 months after the surgery