Evaluation of the Long-term Outcome After Bariatric Surgery in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-surgical impact on body weight
研究概览
简要总结
There is a lack of long-term data on the impact of bariatric surgery in type 1 diabetes (T1D). The aim of this study is to gain long-term outcome data on the effects of bariatric surgery in obese patients with T1D.
详细描述
This study aims to evaluate long-term data on the effect of bariatric surgery in T1D regarding weight lost, insulin-requirement, and quality of life.
Inclusion criteria are patients who underwent bariatric surgery (Sleeve, One anastomosis gastric bypass, Roux en Y Gastric Bypass) and the presence of T1D prior to surgery. Labor parameters include verification of T1D antibodies, and level of C-peptide. Exclusion criteria is T2D.
In order to obtain a sufficient number of patients for the evaluation, several sites are involved in the acquisition of these specific data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D-specific antibodies
- •C-peptide level
- •status after bariatric surgery
排除标准
- •patients without T1D
- •patients with T1d without bariatric surgery
结局指标
主要结局
Post-surgical impact on body weight
时间窗: 1 year
Body weight in kgpost-surgical A1c course
次要结局
- Post-surgical impact on metabolic changes(1 year)
- Post-surgical impact on body weight and metabolic changes(1 year)
研究者
Christine Stier
Study coordinator
Sana Klinikum Offenbach