Diabetes Mellitus, Dyslipidemias, Metabolic Syndrome, Obesity, PreDiabetes
Conditions
Keywords
bariatric surgery, diabetes treatment, prediabetes treatment, metabolic surgery
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.
Interventions
PROCEDUREBariatric surgery
Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity
Sponsors
Medical University of Bialystok
University of Copenhagen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Circulating microRNA | 1, 3, 6, 12 and 24 months after the surgery | Changes in circulating microRNAs expression, 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 |
| 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 |
| 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 |
Countries
Poland
Outcome results
None listed