An observational study in Diabetes Mellitus, Type 2, sponsored by Berner Klinik Montana. Completed at 1 site in Switzerland. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Berner Klinik Montana · Observational
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.
Ambulatory patients above the age of 40 who provide informed consent.
Exclusion Criteria:
Patients with T2DM under new therapy with SGLT-2-Inhibitors (Empagliflozin 10 mg per day, Dapagliflozin 10 mg per day, Canagliflozin 100 mg per day) at baseline.
Patients with T2DM without therapy with SGLT-2-Inhibitors (Empagliflozin 10 mg per day, Dapagliflozin 10 mg per day, Canagliflozin 100 mg per day) at baseline.
Patients without T2DM manifesting similar comorbidities (Haemoglobin value, renal function, similar body mass index, cardiovascular disease profile)
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
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
Echocardiographic parameters (GLS)
Change in left ventricular systolic function using global longitudinal strain Imaging: GLS expressed as GLS avg in minus %.
Time frame: 28 days
Biochemical (NTproBNP)
change in routine laboratory parameter related to cardiac function using measurements of NTproBNP in ng/l
Time frame: 28 days
Echocardiographic parameters (LVEDV)
Change in left ventricular structure using B-mode Imaging: LVEDV in mm
Time frame: 28 days
Echocardiographic parameters (LAVI)
Change in left atrial structure structure using Biplane method: LAVI in ml/m2
Time frame: 28 days
Echocardiographic parameters (LV Massindex)
Change in left ventricular structure using B-mode Imaging: LV Massindex in g/m2
Time frame: 28 days
Echocardiographic parameters (E/e' avg)
Change in left ventricular diastolic function using Mitral inflow E velocity as obtained by pulsed-wave (PW) Doppler expressed E/e' avg ratio
Time frame: 28 days
Plan to share: Undecided — Results of the study for academic purposes for trainees to get an academic degree within Switzerland.
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