Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin. (ZODIAC-39)
A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (RCTs).
With this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.
研究概览
详细说明
This prospective cohort study is part of the ZODIAC (Zwolle Outpatient Diabetes project Integrating Available Care) study, which started in 1998 as a prospective observational study and includes patients with known T2DM who are treated in primary care.
The investigators aim to investigate the course of the bodyweight and glycaemic control, the years after starting specific SU's, pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
As part of the process called benchmarking, a dataset of quality measures is collected annually for all patients participating in the ZODIAC study during the patient's visit to the practice nurse and/or general practitioner and sent to the investigators' diabetes centre for benchmarking and research purposes once a year.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Overijssel
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Zwolle、Overijssel、荷兰、8000 AB
- Isala
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- T2DM
- Treated in primary care in period 1998 to 2012
- used metformin monotherapy
- subsequently received add-on therapy with a SU or pioglitazone during their entire follow-up period
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients on metformin mono-therapy who receive add-on
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.
大体时间：Up to 5 years
|
The course of the bodyweight up to five years after starting individual SU's (gliclazide/glibenclamide/tolbutamide/glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
|
Up to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.
大体时间：Up to 5 years
|
The course of the glycaemic control, up to five years after starting individual SU's (gliclazide, glibenclamide, tolbutamide, glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
|
Up to 5 years
|
合作者和调查者
调查人员
- 首席研究员：G. W.D. Landman, MD PhD、Isala, Diabetes Centre
- 首席研究员：R. Wever, MD、Isala, Diabetes Centre
- 首席研究员：P. R. van Dijk, MD、Isala, Diabetes Centre
- 研究主任：Nanne Kleefstra, MD PhD、Diabetes Centre, Isala, Zwolle
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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