Performance Under SGLT-2-Inhibitors in Humans

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Performance in Patients With Type-II-Diabetes Mellitus Under New Treatment With SGLT-2-Inhibitors Compared to Control Groups.

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent ambulatory patients Exclusion Criteria: relevant limitations in movement

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with T2DM under new therapy with SGLT-2-Inhibitors<br>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.<br>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<br>Patients without T2DM manifesting similar comorbidities (Haemoglobin value, renal function, similar body mass index, cardiovascular disease profile) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGLT-2-Inhibitor, Empagliflozin, Canagliflozin, Dapagliflozin