Clinical trial NCT03422263: Performance Under SGLT-2-Inhibitors in Humans
Official title: Early Performance in Patients With Type-II-Diabetes Mellitus Under New Treatment With SGLT-2-Inhibitors Compared to Control Groups.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: SGLT-2-Inhibitor, Empagliflozin, Canagliflozin, Dapagliflozin
Lead sponsor: Berner Klinik Montana
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory patients above the age of 40 who provide informed consent.

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.

Eligibility criteria: Inclusion Criteria:

* informed consent
* ambulatory patients

Exclusion Criteria:

* relevant limitations in movement

Primary outcomes:
measure: Distance
timeFrame: 28 days
measure: Rate of perceived exertion
timeFrame: 28 days
measure: Saturation
timeFrame: 28 days
measure: Heart rate after exertion
timeFrame: 28 days
measure: Maximum oxygen uptake
timeFrame: 28 days
Secondary outcomes:
measure: Muscle anatomy
timeFrame: 28 days
measure: Muscle physiology
timeFrame: 28 days
measure: Biochemical
timeFrame: 28 days
measure: Subjective Assessment
timeFrame: 28 days
measure: Echocardiographic parameters (function)
timeFrame: 28 days
measure: Muscle anatomy (echogenicity)
timeFrame: 28 days
measure: Biochemical (metabolic function)
timeFrame: 28 days
measure: Body constitution (BMI)
timeFrame: 28 days
measure: Body constitution (Hip circumference)
timeFrame: 28 days
measure: Body constitution (Muscle mass predicted I)
timeFrame: 28 days
measure: Body constitution (Muscle mass predicted II)
timeFrame: 28 days
Other outcomes:
measure: Echocardiographic parameters (GLS)
timeFrame: 28 days
measure: Biochemical (NTproBNP)
timeFrame: 28 days
measure: Echocardiographic parameters (LVEDV)
timeFrame: 28 days
measure: Echocardiographic parameters (LAVI)
timeFrame: 28 days
measure: Echocardiographic parameters (LV Massindex)
timeFrame: 28 days
measure: Echocardiographic parameters (E/e' avg)
timeFrame: 28 days
Locations:
city: Crans-Montana
country: Switzerland
facility: Berner Klinik Montana
state: Valais
Study officials:
affiliation: Berner Klinik Montana
name: Devine S Frundi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.