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.
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.
Study Type
OBSERVATIONAL
Enrollment
450
Berner Klinik Montana
Crans-Montana, Valais, Switzerland
Distance
Change in distance covered in metres (m).
Time frame: 28 days
Rate of perceived exertion
Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10)
Time frame: 28 days
Saturation
Change in saturation after exertion, expressed in %
Time frame: 28 days
Heart rate after exertion
Change in heart rate after exertion, expressed as bpm
Time frame: 28 days
Maximum oxygen uptake
Change in predicted VO2 max using distance covered in 6 minute walk test as follows 4.948 0.023\*Mean 6 MWD (meters)
Time frame: 28 days
Muscle anatomy
Change in muscle architecture parameter (MAP) measured as the mid-thigh diameter of the medial vastus muscle using B-mode sonography in centimètres (cm).
Time frame: 28 days
Muscle physiology
Muscle strength measured as hand grip in Newton using a hand dynamometer in kg
Time frame: 28 days
Biochemical
change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum, CK in U/l
Time frame: 28 days
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Subjective Assessment
Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient (Range 20 - 100).
Time frame: 28 days
Echocardiographic parameters (function)
Change in left ventricular function using doppler readings of LVOT: LVEF using Dusmenil Formula SV/LVEDV expressed in %.
Time frame: 28 days
Muscle anatomy (echogenicity)
Change in muscle architecture parameter (MAP) measured as the mid-thigh echogenicity of the lateral vastus muscle, using image J software, arbitary units (AU)
Time frame: 28 days
Biochemical (metabolic function)
change in routine laboratory parameter related to metabolic function: Uric acid in serum, expressed in micromol/l
Time frame: 28 days
Body constitution (BMI)
change in body mass index measured as weight/height x height expressed in kg/m2
Time frame: 28 days
Body constitution (Hip circumference)
change in hip circumference measured at the maximum posterior protrusion of the buttocks in cm
Time frame: 28 days
Body constitution (Muscle mass predicted I)
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
Time frame: 28 days
Body constitution (Muscle mass predicted II)
change in muscle mass predicted using the muscle thickness of the forearm (4.89xMT-Ulna(cm)xHeight(m)-9.15) in kg
Time frame: 28 days