The Bialystok Bariatric Surgery Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Homeostatic model assessment for insulin resistance (HOMA-IR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •substance abuse,
- •uncontrolled psychiatric illness
- •expected lack of compliance
- •advanced-stage cancer
- •Non-obese control group:
研究组 & 干预措施
Obesity - undergoing bariatric surgery
Patients with morbid obesity, treated with the bariatric surgery
干预措施: Bariatric surgery (Procedure)
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)
结局指标
主要结局
Homeostatic model assessment for insulin resistance (HOMA-IR)
时间窗: 1, 3, 6, 12 and 24 months after the surgery
Changes in Homeostatic model assessment for insulin resistance under the surgery
High-density lipoprotein cholesterol (HDL)
时间窗: 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
Total cholesterol
时间窗: 1, 3, 6, 12 and 24 months after the surgery
Changes in serum total cholesterol concentration under the surgery, measured using the colorimetric method
Changes in glucose and insulin concentrations during the oral glucose tolerance test (OGTT)
时间窗: 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
Changes in GI hormones concentrations during the mixed meal tolerance test (MMTT)
时间窗: 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
Fasting glucose
时间窗: 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
Triglycerides (TG)
时间窗: 1, 3, 6, 12 and 24 months after the surgery
Changes in serum triglycerides concentration under the surgery, measured using the colorimetric method
Haemoglobin A1c (HbA1c)
时间窗: 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
Weight loss
时间窗: 1, 3, 6, 12 and 24 months after the surgery
Changes in total body weight under the surgery
Lean body mass
时间窗: 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)
Fat mass
时间窗: 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)
Low-density lipoprotein cholesterol (LDL)
时间窗: 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
Fasting insulin
时间窗: 1, 3, 6, 12 and 24 months after the surgery
Changes in fasting insulin concentration under the surgery, measured by the immunoradiometric assay (IRMA)
2-hour glucose
时间窗: 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
Visceral adipose tissue mass
时间窗: 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)
Homeostatic model assessment of beta cell function (HOMA-beta)
时间窗: 1, 3, 6, 12 and 24 months after the surgery
Changes in Homeostatic model assessment of beta cell function under the surgery
Changes in glucose and insulin concentrations during the mixed meal tolerance test (MMTT)
时间窗: 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
Changes in GI hormones concentrations during the oral glucose tolerance test (OGTT)
时间窗: 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
次要结局
- Plasma metabolome(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)
- Liver methylome(1, 3, 6, 12 and 24 months after the surgery)
- Circulating microRNA(1, 3, 6, 12 and 24 months after the surgery)
- Plasma proteome(1, 3, 6, 12 and 24 months after the surgery)
- Adipose tissue transcriptome(1, 3, 6, 12 and 24 months after the surgery)
- Adipose tissue methylome(1, 3, 6, 12 and 24 months after the surgery)
- Skeletal muscle methylome(1, 3, 6, 12 and 24 months after the surgery)