Performance Under SGLT-2-Inhibitors in Humans (PUSH)
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|ClinicalTrials.gov Identifier: NCT03422263|
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
|Condition or disease|
|Diabetes Mellitus, Type 2|
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|
|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|
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)
- 6 minute walk test [ Time Frame: 28 days ]Change in distance covered.
- 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.
- Muscle physiology [ Time Frame: 28 days ]Muscle strength measured as hand grip in Newton using a hand dynamometer
- Biochemical [ Time Frame: 28 days ]change in routine laboratory parameter related to muscle status using measurements of creatinine kinase in serum
- Subjective Assessment [ Time Frame: 28 days ]Change in fatigue using a Fatigue Score questionnaire (FSMC) as assessed by patient.
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
|Contact: Devine S Frundi, MD||+41 27 485 firstname.lastname@example.org|
|Berner Klinik Montana||Recruiting|
|Crans-Montana, Valais, Switzerland, 3963|
|Contact: Devine S Frundi, MD +41 274855242 email@example.com|
|Principal Investigator:||Devine S Frundi, MD||Berner Klinik Montana|