Type 2 Diabetes Mellitus Clinical Trial
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
In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central sympathic nervous activity will be examined.
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.
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