NCT03422263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.7 years

First QC Date

January 23, 2018

Last Update Submit

October 6, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

SGLT-2-Inhibitor, Empagliflozin, Canagliflozin, Dapagliflozin

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (11)

  • Muscle anatomy

    28 days

  • Muscle physiology

    28 days

  • Biochemical

    28 days

  • Subjective Assessment

    28 days

  • Echocardiographic parameters (function)

    28 days

  • +6 more secondary outcomes

Other Outcomes (6)

  • Echocardiographic parameters (GLS)

    28 days

  • Biochemical (NTproBNP)

    28 days

  • Echocardiographic parameters (LVEDV)

    28 days

  • +3 more other outcomes

Study Arms (3)

Patients with T2DM under new therapy with SGLT-2-Inhibitors

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.

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

Patients without T2DM manifesting similar comorbidities (Haemoglobin value, renal function, similar body mass index, cardiovascular disease profile)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory patients above the age of 40 who provide informed consent.

You may qualify if:

  • informed consent
  • ambulatory patients

You may not qualify if:

  • relevant limitations in movement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berner Klinik Montana

Crans-Montana, Valais, 3963, Switzerland

Location

Related Publications (2)

  • Kettig E, Kistler-Fischbacher M, de Godoi Rezende Costa Molino C, Bischoff-Ferrari HA, Frundi DS. Association of magnesium and vitamin D status with grip strength and fatigue in older adults: a 4-week observational study of geriatric participants undergoing rehabilitation. Aging Clin Exp Res. 2023 Aug;35(8):1619-1629. doi: 10.1007/s40520-023-02450-7. Epub 2023 Jun 7.

    PMID: 37285075DERIVED

  • 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.

    PMID: 35935634DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Devine S Frundi, MD

    Berner Klinik Montana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead physician of internal medicine (Leitender Arzt Medizin)

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 5, 2018

Study Start

January 1, 2018

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

CH(1)