Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change in areal bone mineral density at lumbar spine, hip and radius
研究概览
简要总结
Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in popularity in people with type 2 diabetes and may impact bone health. Objectives: To evaluate the impact of the most popular bariatric procedure worldwide (sleeve gastrectomy (SG)) on vBMD by QCT in patients with type 2 diabetes; Secondary aims: (1) to identify the determinants of vBMD after bariatric surgery in patients with type 2 diabetes; (2) to compare vBMD and its potential determinants after bariatric surgery with obese controls without diabetes as well as with controls without obesity and normoglycemia.
详细描述
This is a multicentre, prospective and observational study comprising a bariatric group with or without diabetes undergoing SG (n=70) and one control group (n=30).
Outcome measures are assessed before and at 4 months, 8 months, one year and 3 years after surgery in the bariatric groups and at a single visit for the control group.
Bariatric groups will include adult men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy and followed at 0, 4 months, 8 months, 1 year and 3 years after surgery, and the control group will consist of 30 overweight individuals (10 men, 10 premenopausal women, 10 menopausal women) and without diabetes or prediabetes and assessed at a single visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •bariatric groups: men and women; 18 to 60 years old; with a BMI >=35 kg/m2; with type 2 diabetes: use of oral hypoglycemic agents or insulin OR 2 of the following tests confirming type 2 diabetes: HbA1c >=6.5%; fasting glucose >=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) >=11.1 mM) (guidelines.diabetes.ca);) or without diabetes: HbA1c <6.5% AND fasting glucose <7.0 mM; who are awaiting bariatric surgery. Control group: BMI 25.0 to 29.9 kg/m2 (overweight group); without diabetes or prediabetes: HbA1c <6.0% AND fasting glucose <6.1 mM (Diabetes Canada criteria), with a stable weight for the last 3 months.
排除标准
- •bariatric groups: type 1 diabetes; disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance <60 ml/min) or medication (e.g. glucocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism; BMI>60 kg/m2; CT scan impossible to perform (e.g. patient too large for the gantry aperture); pregnant women or women who plan to become pregnant during the study or women of childbearing age who do not agree to take an appropriate contraceptive method during the study; history of oesophageal, gastric or digestive surgery; history of bariatric surgery; cancer at risk of recurrence during the study; Prosthesis that could interfere with interpretation of imaging data; Chronic severe condition or illness precluding from participation in the project.
- •Control group: Same criteria plus: >5% change in weight in the last 3 months; pregnancy or lactation in the last year.
结局指标
主要结局
Change in areal bone mineral density at lumbar spine, hip and radius
时间窗: before, 1 year after and 3 years after bariatric surgery
assessed by dual-energy X-ray absorptiometry (DXA)
Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius
时间窗: before, 1 year after and 3 years after bariatric surgery
assessed by quantitative computed tomography (QCT)
次要结局
- Change in serum advanced glycation end products (AGEs)(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in HbA1c(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in estradiol and estrone(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in sclerostin(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in N-terminal propeptide of type 1 procollagen (P1NP)(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in C-telopeptide(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in fasting glucose(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in fasting insulin(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in serum 25-hydroxyvitamin D(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in insulin like growth factor (IGF)-1(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in peptide YY (PYY)(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in oxidative stress markers(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in self-reported physical activity level(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in measured physical activity level(before, 1 year after and 3 years after bariatric surgery)
- Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated)(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in parathormone (PTH)(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in adiponectin(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in leptin(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in Free fatty acids (FFA)(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in fat and lean mass(before, 1 year after and 3 years after bariatric surgery)
- Change in muscle mass and fat content at mid-femur(before, 1 year after and 3 years after bariatric surgery)
- Change in upper extremity muscle strength(before, 1 year after and 3 years after bariatric surgery)
- Change in muscle function(before, 1 year after and 3 years after bariatric surgery)
- Change in gut microbiota(before, 1 year after and 3 years after bariatric surgery)
- Change in cutaneous Advanced glycation end products (AGEs)(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in ghrelin(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in visceral and subcutaneous adipose tissue(before, 1 year after and 3 years after bariatric surgery)
- Change in physical capacity(before, 1 year after and 3 years after bariatric surgery)
- Change in balance(before and 1 year after bariatric surgery)
- Change in sociodemographic factors(before, 1 year after and 3 years after bariatric surgery)
- Change in nutrition(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in bone alkaline phosphatase(before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery)
- Change in lower extremity muscle strength(before, 1 year after and 3 years after bariatric surgery)
研究者
Claudia Gagnon
Dr
CHU de Quebec-Universite Laval