Bariatric surgery: Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Clinical Research Centre, Medical University of Bialystok
Bialystok
Podlaskie Voivodeship
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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