Effect of Gastric Bypass Surgery on Diabetes Status and Microvascular Complications in Obese Type 2 Diabetic Patients: Register-based and Clinical Follow-up Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Number of patients with HbA1c<48 mmol/mol.
研究概览
简要总结
This study evaluates the long-term benefits of Roux-en-Y gastric bypass (RYGB) on type 2 diabetes mellitus, focussing on the prevalence and predictors of T2DM improvement and remission after RYGB, and subsequently relapse of type 2 diabetes mellitus after RYGB. Moreover, the study evaluates the possible effect of RYGB on diabetic microvascular complications such as nephropathy and retinopathy. Finally, the study provides insight into the factors influencing glucose-insulin homeostasis after RYGB, including altered microbiota diversity and bile acid levels.
详细描述
One hundred Danish type 2 diabetes mellitus (T2DM) patients who underwent Roux-en-Y gastric bypass surgery (RYGB) between 2006-2011 will be evaluated clinically together with 50 T2DM patients, matched on gender, age, presurgical body mass index, and diabetes duration.
The clinical follow-up consists of a physiological check-up, a thorough paraclinical work-up, and a whole body dual-energy x-ray absorptiometry (body composition and bone mineral density) a peripheral quantitative compute tomography (HR-pQCT), stool samples (microbiota), ophthalmological examination including retina photo, and a questionaire.
More over, a liquid meal test with sampling of total bile acids, fibroblast growth factor 19 and 21 (FGF 19 and FGF 21), plasma glucose, and insulin will be performed on a smaller part of the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •speaks and understands Danish
- •presents written concent
- •cases must be Roux-en-Y operated between 2006-2011.
排除标准
- •Converted Roux-en-Y
- •chronic inflammatory bowel disease
- •ischemic heart disease
- •liver disease
- •cholecystectomy.
- •Controls can not be bariatric operated.
结局指标
主要结局
Number of patients with HbA1c<48 mmol/mol.
时间窗: Maximum follow-up is 121 months (january 2006-february 2016)
次要结局
- Number of patients with two-step change from preoperative level on the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) scale(From operation/inclusion to end of follow-up february 2016, maximum follow-up 121 months)
- Number of patients with T-score <-2,5 evaluated by dual energy xray absorptiometry(Maximum follow-up is 121 months (january 2006-february 2016))
- Number of patients with urine albumin/creatinin< 30 mg/g(Maximum follow-up is 121 months (january 2006-february 2016))