Diabetes Mellitus, Type 2PUSHNCT03422263
Performance Under SGLT-2-Inhibitors in Humans
An observational study of Diabetes Mellitus, Type 2, run by Berner Klinik Montana at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 450 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 30 Sep 2020
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ambulatory patients above the age of 40 who provide informed consent.
Who may be able to join
- informed consent
- ambulatory patients
Who cannot join
- relevant limitations in movement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Performance in Patients With Type-II-Diabetes Mellitus Under New Treatment With SGLT-2-Inhibitors Compared to Control Groups.
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- SGLT-2-Inhibitor, Empagliflozin, Canagliflozin, Dapagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance
Change in distance covered in metres (m).
Measured: 28 days
Rate of perceived exertion
Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10)
Measured: 28 days
Saturation
Change in saturation after exertion, expressed in %
Measured: 28 days
Heart rate after exertion
Change in heart rate after exertion, expressed as bpm
Measured: 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)
Measured: 28 days
Secondary outcomes (11)
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).
Measured: 28 days
Muscle physiology
Muscle strength measured as hand grip in Newton using a hand dynamometer in kg
Measured: 28 days
Biochemical
change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum, CK in U/l
Measured: 28 days
Subjective Assessment
Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient (Range 20 - 100).
Measured: 28 days
Echocardiographic parameters (function)
Change in left ventricular function using doppler readings of LVOT: LVEF using Dusmenil Formula SV/LVEDV expressed in %.
Measured: 28 days
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)
Measured: 28 days
Biochemical (metabolic function)
change in routine laboratory parameter related to metabolic function: Uric acid in serum, expressed in micromol/l
Measured: 28 days
Body constitution (BMI)
change in body mass index measured as weight/height x height expressed in kg/m2
Measured: 28 days
Body constitution (Hip circumference)
change in hip circumference measured at the maximum posterior protrusion of the buttocks in cm
Measured: 28 days
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
Measured: 28 days
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jan 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Berner Klinik Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devine Frundi, Berner Klinik Montana
- Investigators
- Devine S Frundi, MD, Principal investigator, Berner Klinik Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422263
- Sponsor's protocol ID
- Bernerklinik
- Acronym
- PUSH
- Status last verified
- Oct 2020
- First submitted
- 23 Jan 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Results of the study for academic purposes for trainees to get an academic degree within Switzerland.
Publications
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.
PubMed 37285075Frundi 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.
PubMed 35935634
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Performance in Patients With Type-II-Diabetes Mellitus Under New Treatment With SGLT-2-Inhibitors Compared to Control Groups.
- ClinicalTrials.gov ID
- NCT03422263
- Acronym / sponsor ID
- PUSH / Bernerklinik
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- SGLT-2-Inhibitor, Empagliflozin, Canagliflozin, Dapagliflozin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Berner Klinik MontanaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory patients above the age of 40 who provide informed consent.
Key inclusion criteria (2 listed)
- informed consent
- ambulatory patients
Key exclusion criteria (1 listed)
- relevant limitations in movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distance
Time frame: 28 days
Change in distance covered in metres (m).
Rate of perceived exertion
Time frame: 28 days
Change in modified Borg Scale as subjective assessment of moderate intensity physical activity ( Range 0 - 10)
Saturation
Time frame: 28 days
Change in saturation after exertion, expressed in %
Heart rate after exertion
Time frame: 28 days
Change in heart rate after exertion, expressed as bpm
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)
11 secondary outcomes
Muscle anatomy
Time frame: 28 days
Muscle physiology
Time frame: 28 days
Biochemical
Time frame: 28 days
Subjective Assessment
Time frame: 28 days
Echocardiographic parameters (function)
Time frame: 28 days
Muscle anatomy (echogenicity)
Time frame: 28 days
Biochemical (metabolic function)
Time frame: 28 days
Body constitution (BMI)
Time frame: 28 days
Body constitution (Hip circumference)
Time frame: 28 days
Body constitution (Muscle mass predicted I)
Time frame: 28 days
Body constitution (Muscle mass predicted II)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 37285075Kettig 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.
- Derived from this study: PubMed 35935634Frundi 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.
- Individual participant dataSharing planned: Undecided. Results of the study for academic purposes for trainees to get an academic degree within Switzerland.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devine S Frundi, MD principal investigator
Berner Klinik Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Berner Klinik Montana at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance (time frame: 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.