Early Performance in Patients With Type-II-Diabetes Mellitus Under New Treatment With SGLT-2-Inhibitors Compared to Control Groups.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Rate of perceived exertion
研究概览
简要总结
The PUSH Study is conceived to investigate the early effects of SGLT-2-Inhibitors on the physical performance of patients with Type-II-Diabetes mellitus compared to patients under other therapy regimes. Patients shall be divided into 3 groups: I - Patients with type II diabetes mellitus under new treatment with an SGLT2-Inhibitor. II - Patients with type II diabetes mellitus without SGLT-2- Inhibitor medication. III - Patients without type II diabetes mellitus but with similar comorbidities to the previous groups.
详细描述
SGLT-2-Inhibitors have been shown to improve cardiovascular outcomes in patients with type II diabetes mellitus. Present evidence shows this effect to be not directly related to better serum glucose levels because the effect was measurable within several days of initiation of the treatment.
In a prospective single-centre double-blinded comparative observational study, other aspects of the effect of SGLT-2-Inhibitors shall be analyzed from patient registry, particularly the physical performance of patients under new treatment with SGLT-2-Inhibitors. Patient consent will be sort for the analysis of clinical data during the duration of stay.
Patients included in the registry suitable for analysis shall be divided into 3 groups: I - Patients with type II diabetes mellitus under new treatment with an SGLT2-Inhibitor. II - Patients with type II diabetes mellitus without SGLT-2- Inhibitor medication. III - Patients without type II diabetes mellitus but with similar comorbidities to the previous groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •ambulatory patients
排除标准
- •relevant limitations in movement
结局指标
主要结局
Rate of perceived exertion
时间窗: 28 days
Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10)
Maximum oxygen uptake
时间窗: 28 days
Change in predicted VO2 max using distance covered in 6 minute walk test as follows 4.948 0.023\*Mean 6 MWD (meters)
Distance
时间窗: 28 days
Change in distance covered in metres (m).
Saturation
时间窗: 28 days
Change in saturation after exertion, expressed in %
Heart rate after exertion
时间窗: 28 days
Change in heart rate after exertion, expressed as bpm
次要结局
- Echocardiographic parameters (function)(28 days)
- Biochemical (metabolic function)(28 days)
- Biochemical(28 days)
- Body constitution (Muscle mass predicted II)(28 days)
- Muscle anatomy(28 days)
- Muscle physiology(28 days)
- Subjective Assessment(28 days)
- Body constitution (Muscle mass predicted I)(28 days)
- Muscle anatomy (echogenicity)(28 days)
- Body constitution (BMI)(28 days)
- Body constitution (Hip circumference)(28 days)
研究者
Devine Frundi
Lead physician of internal medicine (Leitender Arzt Medizin)
Berner Klinik Montana