ClinicalTrials.gov
ClinicalTrials.gov Menu

Performance Under SGLT-2-Inhibitors in Humans (PUSH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03422263
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Devine Frundi, 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.

Condition or disease
Diabetes Mellitus, Type 2

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 Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Early Performance in Patients With Type-II-Diabetes Mellitus Under New Treatment With SGLT-2-Inhibitors Compared to Control Groups.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 28 days ]
    Change in distance covered.


Secondary Outcome Measures :
  1. Muscle anatomy [ Time Frame: 28 days ]
    Change in muscle architecture parameter (MAP) measured as the mid-thigh diameter of the medial vastus muscle using B-mode sonography.

  2. Muscle physiology [ Time Frame: 28 days ]
    Muscle strength measured as hand grip in Newton using a hand dynamometer

  3. Biochemical [ Time Frame: 28 days ]
    change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum

  4. Subjective Assessment [ Time Frame: 28 days ]
    Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory patients above the age of 40 who provide informed consent.
Criteria

Inclusion Criteria:

  • informed consent
  • ambulatory patients

Exclusion Criteria:

  • relevant limitations in movement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422263


Contacts
Contact: Devine S Frundi, MD +41 27 485 5277 devine.frundi@bernerklinik.ch

Locations
Switzerland
Berner Klinik Montana Recruiting
Crans-Montana, Valais, Switzerland, 3963
Contact: Devine S Frundi, MD    +41 274855242    devine.frundi@bernerklinik.ch   
Sponsors and Collaborators
Berner Klinik Montana
Investigators
Principal Investigator: Devine S Frundi, MD Berner Klinik Montana

Responsible Party: Devine Frundi, Lead physician of internal medicine (Leitender Arzt Medizin), Berner Klinik Montana
ClinicalTrials.gov Identifier: NCT03422263     History of Changes
Other Study ID Numbers: Bernerklinik
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Results of the study for academic purposes for trainees to get an academic degree within Switzerland.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Devine Frundi, Berner Klinik Montana:
Type 2 diabetes mellitus, SGLT-2-Inhibitors, Empagliflozin, Canagliflozin, Dapagliflozin, 6-minute walk test.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs