Performance Under SGLT-2-Inhibitors in Humans

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT03422263
• Lead Sponsor: Berner Klinik Montana

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-05
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• informed consent
• ambulatory patients

Exclusion Criteria

• relevant limitations in movement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of perceived exertion	28 days	Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10)
Saturation	28 days	Change in saturation after exertion, expressed in %
Maximum oxygen uptake	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)
Distance	28 days	Change in distance covered in metres (m).
Heart rate after exertion	28 days	Change in heart rate after exertion, expressed as bpm

Secondary Outcome Measures

Name	Time	Method
Echocardiographic parameters (function)	28 days	Change in left ventricular function using doppler readings of LVOT: LVEF using Dusmenil Formula SV/LVEDV expressed in %.
Biochemical	28 days	change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum, CK in U/l
Biochemical (metabolic function)	28 days	change in routine laboratory parameter related to metabolic function: Uric acid in serum, expressed in micromol/l
Body constitution (Muscle mass predicted II)	28 days	change in muscle mass predicted using the muscle thickness of the forearm (4.89xMT-Ulna(cm)xHeight(m)-9.15) in kg
Muscle anatomy	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).
Muscle physiology	28 days	Muscle strength measured as hand grip in Newton using a hand dynamometer in kg
Subjective Assessment	28 days	Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient (Range 20 - 100).
Body constitution (Muscle mass predicted I)	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
Muscle anatomy (echogenicity)	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)
Body constitution (BMI)	28 days	change in body mass index measured as weight/height x height expressed in kg/m2
Body constitution (Hip circumference)	28 days	change in hip circumference measured at the maximum posterior protrusion of the buttocks in cm

Trial Locations

Locations (1)

Berner Klinik Montana; 🇨🇭 Crans-Montana, Valais, Switzerland