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NCT Number: NCT03422263

Performance Under SGLT-2-Inhibitors in Humans

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Berner Klinik Montana

Crans-Montana, Valais, 3963, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent
  • ambulatory patients

Exclusion criteria

  • relevant limitations in movement

Treatment and study plan

Primary outcomes

  1. Distance

    Time frame: 28 days

    Change in distance covered in metres (m).

  2. Rate of perceived exertion

    Time frame: 28 days

    Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10)

  3. Saturation

    Time frame: 28 days

    Change in saturation after exertion, expressed in %

  4. Heart rate after exertion

    Time frame: 28 days

    Change in heart rate after exertion, expressed as bpm

  5. Maximum oxygen uptake

    Time frame: 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)

Secondary outcomes

  1. Muscle anatomy

    Time frame: 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).

  2. Muscle physiology

    Time frame: 28 days

    Muscle strength measured as hand grip in Newton using a hand dynamometer in kg

  3. Biochemical

    Time frame: 28 days

    change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum, CK in U/l

  4. Subjective Assessment

    Time frame: 28 days

    Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient (Range 20 - 100).

  5. Echocardiographic parameters (function)

    Time frame: 28 days

    Change in left ventricular function using doppler readings of LVOT: LVEF using Dusmenil Formula SV/LVEDV expressed in %.

  6. Muscle anatomy (echogenicity)

    Time frame: 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)

  7. Biochemical (metabolic function)

    Time frame: 28 days

    change in routine laboratory parameter related to metabolic function: Uric acid in serum, expressed in micromol/l

  8. Body constitution (BMI)

    Time frame: 28 days

    change in body mass index measured as weight/height x height expressed in kg/m2

  9. Body constitution (Hip circumference)

    Time frame: 28 days

    change in hip circumference measured at the maximum posterior protrusion of the buttocks in cm

  10. Body constitution (Muscle mass predicted I)

    Time frame: 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

  11. Body constitution (Muscle mass predicted II)

    Time frame: 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 outcomes

  1. Echocardiographic parameters (GLS)

    Time frame: 28 days

    Change in left ventricular systolic function using global longitudinal strain Imaging: GLS expressed as GLS avg in minus %.

  2. Biochemical (NTproBNP)

    Time frame: 28 days

    change in routine laboratory parameter related to cardiac function using measurements of NTproBNP in ng/l

  3. Echocardiographic parameters (LVEDV)

    Time frame: 28 days

    Change in left ventricular structure using B-mode Imaging: LVEDV in mm

  4. Echocardiographic parameters (LAVI)

    Time frame: 28 days

    Change in left atrial structure structure using Biplane method: LAVI in ml/m2

  5. Echocardiographic parameters (LV Massindex)

    Time frame: 28 days

    Change in left ventricular structure using B-mode Imaging: LV Massindex in g/m2

  6. Echocardiographic parameters (E/e' avg)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Berner Klinik Montana

Other

Registry information

Official study title

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

Acronym: PUSH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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