BBSS: The Bialystok Bariatric Surgery Study

• Sponsor: Medical University of Bialystok (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04634591
• Collaborator: University of Copenhagen (Other)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 99.7
• Patients Per Site Per Month: 10

Study Details

Study Description

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	Phase
Obesity; Diabetes Mellitus; Metabolic Syndrome; Dyslipidemias; PreDiabetes	Procedure: Bariatric surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Bialystok Bariatric Surgery Study
• Actual Study Start Date: Sep 10, 2015
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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 Names: 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

Primary Outcome Measures

1. Weight loss [1, 3, 6, 12 and 24 months after the surgery]

   Changes in total body weight under the surgery

2. 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)

3. 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)

4. 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)

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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)

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. Circulating microRNA [1, 3, 6, 12 and 24 months after the surgery]

   Changes in circulating microRNAs expression, in response to the surgery

8. 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

9. 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

10. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Centre, Medical University of Bialystok	Bialystok	Podlaskie	Poland	15-276

Sponsors and Collaborators

• Medical University of Bialystok
• University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Bialystok
• ClinicalTrials.gov Identifier: NCT04634591
• Other Study ID Numbers: R-I-002/546/2015
• First Posted: Nov 18, 2020
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• 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: Metabolic Syndrome; Dyslipidemias; Prediabetic State; Glucose Intolerance

Study Results

No Results Posted as of Apr 4, 2022