The Bialystok Bariatric Surgery Study
- Conditions
- PreDiabetesObesityDiabetes MellitusMetabolic SyndromeDyslipidemias
- Interventions
- Procedure: Bariatric surgery
- Registration Number
- NCT04634591
- Lead Sponsor
- Medical University of Bialystok
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- substance abuse,
- uncontrolled psychiatric illness
- expected lack of compliance
- advanced-stage cancer
Non-obese control group:
- BMI <30
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obesity - undergoing bariatric surgery Bariatric surgery Patients with morbid obesity, treated with the bariatric surgery
- Primary Outcome Measures
Name Time Method Homeostatic model assessment for insulin resistance (HOMA-IR) 1, 3, 6, 12 and 24 months after the surgery Changes in Homeostatic model assessment for insulin resistance under the surgery
High-density lipoprotein cholesterol (HDL) 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
Total cholesterol 1, 3, 6, 12 and 24 months after the surgery Changes in serum total cholesterol concentration under the surgery, measured using the colorimetric method
Changes in glucose and insulin concentrations during the oral glucose tolerance test (OGTT) 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 GI hormones concentrations during the mixed meal tolerance test (MMTT) 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
Fasting glucose 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) 1, 3, 6, 12 and 24 months after the surgery Changes in serum triglycerides concentration under the surgery, measured using the colorimetric method
Haemoglobin A1c (HbA1c) 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
Weight loss 1, 3, 6, 12 and 24 months after the surgery Changes in total body weight under the surgery
Lean body mass 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 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)
Low-density lipoprotein cholesterol (LDL) 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
Fasting insulin 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 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
Visceral adipose tissue mass 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)
Homeostatic model assessment of beta cell function (HOMA-beta) 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 mixed meal tolerance test (MMTT) 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) 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
- Secondary Outcome Measures
Name Time Method Plasma metabolome 1, 3, 6, 12 and 24 months after the surgery Changes in plasma metabolites concentrations measured using untargeted metabolomics, in response to the surgery
Urine metabolome 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 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 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
Liver methylome 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
Circulating microRNA 1, 3, 6, 12 and 24 months after the surgery Changes in circulating microRNAs expression, in response to the surgery
Plasma proteome 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
Adipose tissue transcriptome 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
Adipose tissue methylome 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
Skeletal muscle methylome 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
Trial Locations
- Locations (1)
Clinical Research Centre, Medical University of Bialystok
🇵🇱Bialystok, Podlaskie, Poland