A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16,293
- 试验地点
- 1
- 主要终点
- The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Patients on metformin mono-therapy who receive add-on
干预措施: individual SUs, insulin, pioglitazone (Drug)
结局指标
主要结局
The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.
时间窗: 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.
次要结局
- The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.(Up to 5 years)
研究者
Gijs Landman
MD, PHD
Medical Research Foundation, The Netherlands