Performance Under SGLT-2-Inhibitors in Humans

Diabetes Mellitus, Type 2 Clinical Trial

— PUSH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422263
• Other study ID #: Bernerklinik
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Berner Klinik Montana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• informed consent

• ambulatory patients

Exclusion Criteria:

• relevant limitations in movement

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Switzerland	Berner Klinik Montana	Crans-Montana	Valais

Sponsors (1)

Lead Sponsor	Collaborator
Berner Klinik Montana

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Echocardiographic parameters (GLS)	Change in left ventricular systolic function using global longitudinal strain Imaging: GLS expressed as GLS avg in minus %.	28 days
Other	Biochemical (NTproBNP)	change in routine laboratory parameter related to cardiac function using measurements of NTproBNP in ng/l	28 days
Other	Echocardiographic parameters (LVEDV)	Change in left ventricular structure using B-mode Imaging: LVEDV in mm	28 days
Other	Echocardiographic parameters (LAVI)	Change in left atrial structure structure using Biplane method: LAVI in ml/m2	28 days
Other	Echocardiographic parameters (LV Massindex)	Change in left ventricular structure using B-mode Imaging: LV Massindex in g/m2	28 days
Other	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
Primary	Distance	Change in distance covered in metres (m).	28 days
Primary	Rate of perceived exertion	Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10)	28 days
Primary	Saturation	Change in saturation after exertion, expressed in %	28 days
Primary	Heart rate after exertion	Change in heart rate after exertion, expressed as bpm	28 days
Primary	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	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
Secondary	Muscle physiology	Muscle strength measured as hand grip in Newton using a hand dynamometer in kg	28 days
Secondary	Biochemical	change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum, CK in U/l	28 days
Secondary	Subjective Assessment	Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient (Range 20 - 100).	28 days
Secondary	Echocardiographic parameters (function)	Change in left ventricular function using doppler readings of LVOT: LVEF using Dusmenil Formula SV/LVEDV expressed in %.	28 days
Secondary	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
Secondary	Biochemical (metabolic function)	change in routine laboratory parameter related to metabolic function: Uric acid in serum, expressed in micromol/l	28 days
Secondary	Body constitution (BMI)	change in body mass index measured as weight/height x height expressed in kg/m2	28 days
Secondary	Body constitution (Hip circumference)	change in hip circumference measured at the maximum posterior protrusion of the buttocks in cm	28 days
Secondary	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
Secondary	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