Empagliflozin and Sympathetic Nerve Traffic
|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: NCT03254849|
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Empagliflozin Drug: Hydrochlorothiazide 25 mg||Phase 4|
The drug empagliflozin is a selective oral inhibitor of the sodium-glucose co-transporter 2 (SGLT-2) in the kidney.On the market empagliflozin is approved for the treatment of type 2 Diabetes. The mechanism of action can be described as follows: SGLT-2 is responsible for 90% of the reabsorption of Glucose in the kidney. If this Transport System is inhibited the secretion of glucose via the urine is increased. Therefore the blood glucose concentration will be lowered.
It has been noted that the SGLT-2 drugs are lowering the blood pressure as well, but the specific characteristics of the durg leading to this effect have not been examined in adequate clinical trial up to now.
To evaluate the central sympathic nervous activity a microneurography will be performed in this study; this examination will provide Information if empagliflozin dose decrease the sympathic nervous activity. If this is the case new effects of empagliflozin have to be discussed, Otherwise it can be assumed that the blood pressure decrease is a result of an increase of urine volume. In this case the sympathic activity should be increased.
This study will be performed in parallel groups who will receive a double-blind, randomised treatment, either empagliflozin or hydrochlorothiazide. The hypothesis that empagliflozin - in contrast to hydrochlorthiazide - does not increase the sympathic nervous activity in obese, hypertensive subjects with type 2 Diabetes treated with metformin will be tested.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effects on Blood Pressure and Central Sympathetic Nerve Traffic by SGLT2-inhibition With Empagliflozin Compared to Hydrochlorothiazide in Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||December 8, 2017|
|Estimated Primary Completion Date :||September 15, 2019|
|Estimated Study Completion Date :||September 15, 2019|
Experimental: empagliflozin 25 mg
Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 1: 25 mg/d empagliflozin + hydrochlorothiazide placebo
Other Name: Jardiance
Experimental: hydrochlorothiazide 25 mg
Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 2: 25 mg/d hydrochlorothiazide + empagliflozin placebo
Drug: Hydrochlorothiazide 25 mg
Other Name: HCT
- Blood Pressure reduction [ Time Frame: 6 weeks ]Blood pressure reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to Hydrochlorothiazide treatment
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): NCT03254849
|Contact: Maren Lübkert||+4921314018 ext email@example.com|
|Profil Institut für Stoffwechselforschung GmbH||Recruiting|
|Neuss, North Rhine-Westphalia, Germany, 41460|
|Contact: Maren Lübkert +49 2131 4018 146 firstname.lastname@example.org|
|Principal Investigator: Tim Heise, MD|
|Principal Investigator:||Tim Heise, MD||Profil Institut für Stoffwechselforschung GmbH|