Effects of Vildagliptin Versus Glibenclamide on Glycemia After Exercise in Patients With Type 2 Diabetes
Status:
Unknown status
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Exercise is considered a way to benefit the health of unhealthy and healthy individuals. This
is confirmed by different scientific researches, in which people who participated improve
their health. The present study will be conducted to test the hypothesis that vildagliptin
associated with metformin may have more impact in improving glucose variability after a
sub-maximal exercise test, as compared to glibenclamide. Our general aim will be to evaluate
glucose variability after the submaximal exercise test under the treatment with vildagliptin
or glibenclamide. The specific aims of this study are to evaluate the oxidative stress,
endothelial function, metabolic and cardiovascular responses to exercise under the treatment
with vildagliptin or glibenclamide. All these responses are important in patients with
Diabetes Mellitus type II. Allied to the patient's routine treatment (metformin), they will
receive orally a second drug, to take in 12 weeks. The patients will be raffled to take one
of the two drugs that act on glycemia, that are called vildagliptin (50 mg of this drug twice
a day) and glibenclamide (5 mg once a day during the first week and later you will increase
to 5 mg twice a day). The metformin drug will continue be used.
Patients who meet the eligible criteria for the study will first make the test of the maximum
effort, to determination of peak oxygen consumption (VO2peak) and ventilatory thresholds.
Forty eight hours after this test, patients will be allowed to do the pre-drugs protocol that
will be given in three consecutive days as explained below.
- Day 1: Begin a 24-hour urinary collection, perform vascular doppler ultrasound to
evaluate endothelial function and then the glucose sensor will be inserted
subcutaneously (begin continuous glucose monitoring system - CGMS evaluation);
- Day 2: End the 24-hour urinary collection, submit to the submaximal test (blood
collection at baseline, 15 and 30 min of the session, and 60 min after recovery). On the
same day, the patients will begin 24h ambulatory blood pressure monitoring (24h-ABPM).
- Day 3: Removal of the glucose sensor; end of the 24h ABPM, randomization. This same
protocol, except the randomization will be repeated at the end of the 12 week treatment.