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The Bialystok Bariatric Surgery Study (BBSS)

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ClinicalTrials.gov Identifier: NCT04634591
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Medical University of Bialystok

Study Description
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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.

Condition or disease Intervention/treatment
Obesity Diabetes Mellitus Metabolic Syndrome Dyslipidemias PreDiabetes Procedure: Bariatric surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Bialystok Bariatric Surgery Study
Actual Study Start Date : September 10, 2015
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Obesity - undergoing bariatric surgery
Patients with morbid obesity, treated with the bariatric surgery
 Procedure: Bariatric surgery
Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity
Other Name: Metabolic surgery
Obesity - without bariatric surgery treatment
Patients with morbid obesity, not treated with the bariatric surgery
Non-obese
Non-obese patients - control group (without obesity and without the bariatric surgery treatment)


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in total body weight under the surgery

  2. Lean body mass [ Time Frame: 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)

  3. Fat mass [ Time Frame: 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)

  4. Visceral adipose tissue mass [ Time Frame: 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)

  5. Fasting glucose [ Time Frame: 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

  6. Triglycerides (TG) [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in serum triglycerides concentration under the surgery, measured using the colorimetric method

  7. High-density lipoprotein cholesterol (HDL) [ Time Frame: 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

  8. Low-density lipoprotein cholesterol (LDL) [ Time Frame: 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

  9. Total cholesterol [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in serum total cholesterol concentration under the surgery, measured using the colorimetric method

  10. Fasting insulin [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in fasting insulin concentration under the surgery, measured by the immunoradiometric assay (IRMA)

  11. 2-hour glucose [ Time Frame: 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

  12. Haemoglobin A1c (HbA1c) [ Time Frame: 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

  13. Homeostatic model assessment for insulin resistance (HOMA-IR) [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in Homeostatic model assessment for insulin resistance under the surgery

  14. Homeostatic model assessment of beta cell function (HOMA-beta) [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in Homeostatic model assessment of beta cell function under the surgery

  15. Changes in glucose and insulin concentrations during the oral glucose tolerance test (OGTT) [ Time Frame: 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

  16. Changes in glucose and insulin concentrations during the mixed meal tolerance test (MMTT) [ Time Frame: 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

  17. Changes in GI hormones concentrations during the oral glucose tolerance test (OGTT) [ Time Frame: 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

  18. Changes in GI hormones concentrations during the mixed meal tolerance test (MMTT) [ Time Frame: 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 Outcome Measures :
  1. Plasma metabolome [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in plasma metabolites concentrations measured using untargeted metabolomics, in response to the surgery

  2. Plasma proteome [ Time Frame: 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

  3. Urine metabolome [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in urine metabolites concentrations measured using untargeted metabolomics, in response to the surgery

  4. Skeletal muscle transcriptome [ Time Frame: 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

  5. Liver transcriptome [ Time Frame: 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

  6. Adipose tissue transcriptome [ Time Frame: 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

  7. Circulating microRNA [ Time Frame: 1, 3, 6, 12 and 24 months after the surgery ]
    Changes in circulating microRNAs expression, in response to the surgery

  8. Liver methylome [ Time Frame: 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

  9. Skeletal muscle methylome [ Time Frame: 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

  10. Adipose tissue methylome [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634591


Locations
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Poland
Clinical Research Centre, Medical University of Bialystok Recruiting
Bialystok, Podlaskie, Poland, 15-276
Contact: Lukasz Szczerbinski, MD, PhD    +48 85 831 81 50    lukasz.szczerbinski@umb.edu.pl   
Principal Investigator: Adam Kretowski, Prof., MD, PhD         
Principal Investigator: Lukasz Szczerbinski, MD, PhD         
Sponsors and Collaborators
Medical University of Bialystok
University of Copenhagen
More Information
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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT04634591    
Other Study ID Numbers: R-I-002/546/2015
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Bialystok:
bariatric surgery
diabetes treatment
prediabetes treatment
metabolic surgery
Additional relevant MeSH terms:
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Metabolic Syndrome
Dyslipidemias
Prediabetic State
Glucose Intolerance
Insulin Resistance
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia