Clinical trial NCT04634591: The Bialystok Bariatric Surgery Study
Official title: The Bialystok Bariatric Surgery Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Diabetes Mellitus
Metabolic Syndrome
Dyslipidemias
PreDiabetes
Keywords: bariatric surgery
diabetes treatment
prediabetes treatment
metabolic surgery
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-11-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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 outcomes:
measure: Weight loss
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Lean body mass
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Fat mass
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Visceral adipose tissue mass
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Fasting glucose
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Triglycerides (TG)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: High-density lipoprotein cholesterol (HDL)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Low-density lipoprotein cholesterol (LDL)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Total cholesterol
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Fasting insulin
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: 2-hour glucose
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Haemoglobin A1c (HbA1c)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Homeostatic model assessment of beta cell function (HOMA-beta)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Changes in glucose and insulin concentrations during the oral glucose tolerance test (OGTT)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Changes in glucose and insulin concentrations during the mixed meal tolerance test (MMTT)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Changes in GI hormones concentrations during the oral glucose tolerance test (OGTT)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Changes in GI hormones concentrations during the mixed meal tolerance test (MMTT)
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
Secondary outcomes:
measure: Plasma metabolome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Plasma proteome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Urine metabolome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Skeletal muscle transcriptome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Liver transcriptome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Adipose tissue transcriptome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Circulating microRNA
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Liver methylome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Skeletal muscle methylome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
measure: Adipose tissue methylome
timeFrame: 1, 3, 6, 12 and 24 months after the surgery
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Clinical Research Centre, Medical University of Bialystok
state: Podlaskie
Study officials:
References: