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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with T2DM under new therapy with SGLT-2-Inhibitors | 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 SGLT-2-Inhibitors. | 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 | Patients without T2DM manifesting similar comorbidities (Haemoglobin value, renal function, similar body mass index, cardiovascular disease profile) |
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| Measure | Description | Time Frame |
|---|---|---|
| Distance | Change in distance covered in metres (m). | 28 days |
| Rate of perceived exertion | Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10) | 28 days |
| Saturation | Change in saturation after exertion, expressed in % | 28 days |
| Heart rate after exertion | Change in heart rate after exertion, expressed as bpm | 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) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 28 days |
| Muscle physiology |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic parameters (GLS) | Change in left ventricular systolic function using global longitudinal strain Imaging: GLS expressed as GLS avg in minus %. | 28 days |
| Biochemical (NTproBNP) | change in routine laboratory parameter related to cardiac function using measurements of NTproBNP in ng/l |
Inclusion Criteria:
Exclusion Criteria:
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Ambulatory patients above the age of 40 who provide informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Devine S Frundi, MD | Berner Klinik Montana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berner Klinik Montana | Crans-Montana | Valais | 3963 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37285075 | Derived | Kettig E, Kistler-Fischbacher M, de Godoi Rezende Costa Molino C, Bischoff-Ferrari HA, Frundi DS. Association of magnesium and vitamin D status with grip strength and fatigue in older adults: a 4-week observational study of geriatric participants undergoing rehabilitation. Aging Clin Exp Res. 2023 Aug;35(8):1619-1629. doi: 10.1007/s40520-023-02450-7. Epub 2023 Jun 7. | |
| 35935634 |
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Results of the study for academic purposes for trainees to get an academic degree within Switzerland.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Muscle strength measured as hand grip in Newton using a hand dynamometer in kg
| 28 days |
| Biochemical | change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum, CK in U/l | 28 days |
| Subjective Assessment | Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient (Range 20 - 100). | 28 days |
| Echocardiographic parameters (function) | Change in left ventricular function using doppler readings of LVOT: LVEF using Dusmenil Formula SV/LVEDV expressed in %. | 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) | 28 days |
| Biochemical (metabolic function) | change in routine laboratory parameter related to metabolic function: Uric acid in serum, expressed in micromol/l | 28 days |
| Body constitution (BMI) | change in body mass index measured as weight/height x height expressed in kg/m2 | 28 days |
| Body constitution (Hip circumference) | change in hip circumference measured at the maximum posterior protrusion of the buttocks in cm | 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 | 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 | 28 days |
| 28 days |
| Echocardiographic parameters (LVEDV) | Change in left ventricular structure using B-mode Imaging: LVEDV in mm | 28 days |
| Echocardiographic parameters (LAVI) | Change in left atrial structure structure using Biplane method: LAVI in ml/m2 | 28 days |
| Echocardiographic parameters (LV Massindex) | Change in left ventricular structure using B-mode Imaging: LV Massindex in g/m2 | 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 | 28 days |
| Frundi DS, Kettig E, Popp LL, Hoffman M, Dumartin M, Hughes M, Lamy E, Fru YJW, Bano A, Muka T, Wilhelm M. Physical performance and glycemic control under SGLT-2-inhibitors in patients with type 2 diabetes and established atherosclerotic cardiovascular diseases or high cardiovascular risk (PUSH): Design of a 4-week prospective observational study. Front Cardiovasc Med. 2022 Jul 22;9:907385. doi: 10.3389/fcvm.2022.907385. eCollection 2022. |
| D004700 | Endocrine System Diseases |