The Bialystok Bariatric Surgery Study

NCT04634591 | Recruiting

• 1 other identifier: R-I-002/546/2015
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome; Dyslipidemias; PreDiabetes; Diabetes Mellitus

Keywords

bariatric surgery; diabetes treatment; prediabetes treatment; metabolic surgery

Outcome Measures

Primary Outcomes (18)

• Weight loss

  Changes in total body weight under the surgery

  1, 3, 6, 12 and 24 months after the surgery

• Lean body mass

  Changes in total lean body mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  1, 3, 6, 12 and 24 months after the surgery

• Fat mass

  Changes in total fat mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  1, 3, 6, 12 and 24 months after the surgery

• Visceral adipose tissue mass

  Changes in visceral adipose tissue mass under the surgery, measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  1, 3, 6, 12 and 24 months after the surgery

• Fasting glucose

  Changes in fasting glucose concentration under the surgery, measured in plasma using the colorimetric method

  1, 3, 6, 12 and 24 months after the surgery

• Triglycerides (TG)

  Changes in serum triglycerides concentration under the surgery, measured using the colorimetric method

  1, 3, 6, 12 and 24 months after the surgery

• High-density lipoprotein cholesterol (HDL)

  Changes in serum High-density lipoprotein cholesterol (HDL) concentration under the surgery, measured using the colorimetric method

  1, 3, 6, 12 and 24 months after the surgery

• Low-density lipoprotein cholesterol (LDL)

  Changes in serum Low-density lipoprotein cholesterol (LDL) concentration under the surgery, measured using the colorimetric method

  1, 3, 6, 12 and 24 months after the surgery

• Total cholesterol

  Changes in serum total cholesterol concentration under the surgery, measured using the colorimetric method

  1, 3, 6, 12 and 24 months after the surgery

• Fasting insulin

  Changes in fasting insulin concentration under the surgery, measured by the immunoradiometric assay (IRMA)

  1, 3, 6, 12 and 24 months after the surgery

• 2-hour glucose

  Changes in glucose concentration at 2-hour of the oral glucose tolerance test under the surgery, measured in plasma using the colorimetric method

  1, 3, 6, 12 and 24 months after the surgery

• Haemoglobin A1c (HbA1c)

  Changes in Haemoglobin A1c under the surgery, measured by the high-performance liquid chromatography (HPLC) method

  1, 3, 6, 12 and 24 months after the surgery

• Homeostatic model assessment for insulin resistance (HOMA-IR)

  Changes in Homeostatic model assessment for insulin resistance under the surgery

  1, 3, 6, 12 and 24 months after the surgery

• Homeostatic model assessment of beta cell function (HOMA-beta)

  Changes in Homeostatic model assessment of beta cell function under the surgery

  1, 3, 6, 12 and 24 months after the surgery

• Changes in glucose and insulin concentrations during the oral glucose tolerance test (OGTT)

  Changes in concentrations of glucose and insulin during the oral glucose tolerance test, under the surgery

  1, 3, 6, 12 and 24 months after the surgery

• Changes in glucose and insulin concentrations during the mixed meal tolerance test (MMTT)

  Changes in concentrations of glucose and insulin during the mixed meal tolerance test, under the surgery

  1, 3, 6, 12 and 24 months after the surgery

• Changes in GI hormones concentrations during the oral glucose tolerance test (OGTT)

  Changes in concentrations of gastrointestinal hormones during the oral glucose tolerance test, under the surgery

  1, 3, 6, 12 and 24 months after the surgery

• Changes in GI hormones concentrations during the mixed meal tolerance test (MMTT)

  Changes in concentrations of gastrointestinal hormones during the mixed meal tolerance test, under the surgery

  1, 3, 6, 12 and 24 months after the surgery

Secondary Outcomes (10)

• Plasma metabolome

  1, 3, 6, 12 and 24 months after the surgery

• Plasma proteome

  1, 3, 6, 12 and 24 months after the surgery

• Urine metabolome

  1, 3, 6, 12 and 24 months after the surgery

• Skeletal muscle transcriptome

  1, 3, 6, 12 and 24 months after the surgery

• Liver transcriptome

  1, 3, 6, 12 and 24 months after the surgery

Study Arms (3)

Obesity - undergoing bariatric surgery

Patients with morbid obesity, treated with the bariatric surgery

Procedure: Bariatric 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)

Interventions

Bariatric surgery PROCEDURE

Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity

Also known as: Metabolic surgery

Obesity - undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• substance abuse,
• uncontrolled psychiatric illness
• expected lack of compliance
• advanced-stage cancer
• Non-obese control group:
• BMI \<30

Sponsors & Collaborators

• Medical University of Bialystok: lead
• University of Copenhagen: collaborator

Study Sites (1)

Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Metabolic Syndrome; Dyslipidemias; Prediabetic State

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: September 10, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2025-05

Locations

PL (1)