The Bialystok Bariatric Surgery Study

Obesity Clinical Trial

— BBSS  

Official title:

The Bialystok Bariatric Surgery Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04634591
• Other study ID #: R-I-002/546/2015
• Status: Recruiting
• Start date: September 10, 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyslipidemias
• Glucose Intolerance
• Metabolic Syndrome
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
Poland	Clinical Research Centre, Medical University of Bialystok	Bialystok	Podlaskie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Bialystok	University of Copenhagen

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Changes in total body weight under the surgery	1, 3, 6, 12 and 24 months after the surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Plasma metabolome	Changes in plasma metabolites concentrations measured using untargeted metabolomics, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Plasma proteome	Changes in plasma proteins concentrations measured using targeted and untargeted proteomics, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Urine metabolome	Changes in urine metabolites concentrations measured using untargeted metabolomics, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Skeletal muscle transcriptome	Changes in skeletal muscle gene and small RNA expressions measured using untargeted transcriptomics, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Liver transcriptome	Changes in liver gene and small RNA expressions measured using untargeted transcriptomics, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Adipose tissue transcriptome	Changes in adipose tissue gene and small RNA expressions measured using untargeted transcriptomics, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Circulating microRNA	Changes in circulating microRNAs expression, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Liver methylome	Changes in liver DNA methylations measured using Reduced representation bisulfite sequencing (RRBS) method, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Skeletal muscle methylome	Changes in skeletal muscle DNA methylations measured using Reduced representation bisulfite sequencing (RRBS) method, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery
Secondary	Adipose tissue methylome	Changes in adipose tissue DNA methylations measured using Reduced representation bisulfite sequencing (RRBS) method, in response to the surgery	1, 3, 6, 12 and 24 months after the surgery