Diabetes Mellitus, Type 2
Conditions
Keywords
SGLT-2-Inhibitor, Empagliflozin, Canagliflozin, Dapagliflozin
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Berner Klinik Montana
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* informed consent * ambulatory patients
Exclusion criteria
* relevant limitations in movement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum oxygen uptake | 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) |
| Heart rate after exertion | 28 days | Change in heart rate after exertion, expressed as bpm |
| Saturation | 28 days | Change in saturation after exertion, expressed in % |
| Rate of perceived exertion | 28 days | Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10) |
| Distance | 28 days | Change in distance covered in metres (m). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic parameters (function) | 28 days | Change in left ventricular function using doppler readings of LVOT: LVEF using Dusmenil Formula SV/LVEDV expressed in %. |
| Muscle anatomy (echogenicity) | 28 days | Change in muscle architecture parameter (MAP) measured as the mid-thigh echogenicity of the lateral vastus muscle, using image J software, arbitary units (AU) |
| Muscle anatomy | 28 days | Change in muscle architecture parameter (MAP) measured as the mid-thigh diameter of the medial vastus muscle using B-mode sonography in centimètres (cm). |
| Muscle physiology | 28 days | Muscle strength measured as hand grip in Newton using a hand dynamometer in kg |
| Biochemical | 28 days | change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum, CK in U/l |
| Subjective Assessment | 28 days | Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient (Range 20 - 100). |
| Biochemical (metabolic function) | 28 days | change in routine laboratory parameter related to metabolic function: Uric acid in serum, expressed in micromol/l |
| Body constitution (BMI) | 28 days | change in body mass index measured as weight/height x height expressed in kg/m2 |
| Body constitution (Hip circumference) | 28 days | change in hip circumference measured at the maximum posterior protrusion of the buttocks in cm |
| Body constitution (Muscle mass predicted I) | 28 days | change in muscle mass predicted using the Baumgartner equation 0.2487(BM) + 0.0483(ST)-0.1584(GQUAD) +0.0732(HGS) +2.5843(SEX) + 5.8828 in kg |
| Body constitution (Muscle mass predicted II) | 28 days | change in muscle mass predicted using the muscle thickness of the forearm (4.89xMT-Ulna(cm)xHeight(m)-9.15) in kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biochemical (NTproBNP) | 28 days | change in routine laboratory parameter related to cardiac function using measurements of NTproBNP in ng/l |
| Echocardiographic parameters (GLS) | 28 days | Change in left ventricular systolic function using global longitudinal strain Imaging: GLS expressed as GLS avg in minus %. |
| Echocardiographic parameters (E/e' avg) | 28 days | Change in left ventricular diastolic function using Mitral inflow E velocity as obtained by pulsed-wave (PW) Doppler expressed E/e' avg ratio |
| Echocardiographic parameters (LV Massindex) | 28 days | Change in left ventricular structure using B-mode Imaging: LV Massindex in g/m2 |
| Echocardiographic parameters (LAVI) | 28 days | Change in left atrial structure structure using Biplane method: LAVI in ml/m2 |
| Echocardiographic parameters (LVEDV) | 28 days | Change in left ventricular structure using B-mode Imaging: LVEDV in mm |
Countries
Switzerland
Outcome results
None listed