Diabetes Mellitus, Type 2 Clinical Trial
— DIABEX-VILDAOfficial title:
A 12-week Study to Compare the Effects of Vildagliptin Versus Glibenclamide on Glycemic Variability After a Sub Maximal Exercise Test in Patients With Type 2 Diabetes Inadequately Controlled With Metformin.
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Type 2 diabetes (fasting glucose = 126 mg/dl or 7.0 mmol/l)(25); - Recent HbA1C determination (between 7, 5 and 10%); - Not involved in regular physical exercise; - Older than 18 years; - In use of Metformin. Exclusion Criteria: - Smoker and use of analgesic or anti-inflammatory drugs during the week of the study - BMI > 40 kg/m²; - Proliferative retinopathy; - Ischemic cardiomyopathy; - Peripheral vascular disease; - Blood Aspartate transaminase (AST) and Alanine transaminase (ALT) 2.5 times higher the normal concentration before screening visit - Lactose intolerance; - Renal insufficiency (creatinine clearance <60ml/min); - Blood pressure more than 180/100mmHg at rest (3 consecutive measures). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre Porto Alegre | Porto Alegre | Rio Grande do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Flow Mediated Dilatation (FMD) | This analysis will be performed by a high-resolution ultrasound of the brachial artery (doppler vascular), which characterizes the Flow Mediated Dilatation (FMD), which is expressed by changes in basal diameter in response to the increased flow and Nitroglycerin (NTG), which will be applied in a single dose (0.4 mg) as a sublingual spray. | Baseline and 12 weeks | No |
Other | Change in Blood pressure variability | Blood Pressure Monitoring Sensor (BPMS)which will be programmed to automatically measuring the blood pressure every 15 minutes during the day (06:00 to 22:00 h), and every 20 minutes during the night (22:00 to 6:00 h. | Baseline and 12 weeks | No |
Other | Change in Plasma glucagon concentration on exercise | EDTA Vacutainer tubes of 10 ml will be used to perform the blood tests and they will be stored at -20º to send them to the Molecular and Proteins Analysis Unit after buying specific kit. | -1h, 0, 15min, 30 min (end), 60min post exercise in baseline and 12 weeks | No |
Other | Change in Oxidative stress (F2 isoprostane 8-iso prostaglandin F2a); | The 24-hour urinary samples will be collected at visit 1 and 4 to evaluate the oxidative stress. Free 8-iso PGF2a that is most frequently measured F2 isoprostane in body fluids. | Baseline and 12 weeks. | No |
Primary | Change in Glycemic variability | Continuous glucose monitoring system (CGMS) during 48 hours (24h before and 24 after the submaximal exercise test). | Baseline and 12 weeks | No |
Secondary | Change in Hemodynamic response to exercise: Cardiac output (Q), Stroke Volume (SV) and blood pressure (BP) | Cardiac output (Q) and the Stroke Volume (SV)and blood pressure (BP) will be measured before the sub-maximal tests, 10% below the second threshold and every 2 minutes of recovery. | Each 2 minutes during exercise and until 60 min post in baseline and 12 weeks | No |
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