Obesity Clinical Trial
Official title:
Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects
NCT number | NCT03089333 |
Other study ID # | 2016004830 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | December 2017 |
Verified date | May 2018 |
Source | University of Campinas, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
New strategies trying to achieve blood pressure control and consequently reduce cardiovascular risk in resistant hypertensive subjects are promising. In this context, the SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a potential drug in order to impact on blood pressure levels, as well as target organ damage and adiposity in this high-risk population.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Resistant hypertension and type 2 diabetes diagnoses after a 6-month follow-up - Use of metformin therapy - Therapy adherence - Agree to participate in the research protocol and sign the informed consent form Exclusion Criteria: - secondary Hypertension - pseudoresistance hypertension (poor medication adherence and white coat hypertension) - patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases - pregnancy - smoking - autoimmune diseases |
Country | Name | City | State |
---|---|---|---|
Brazil | University of Campinas (UNICAMP) | Campinas | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Systolic Blood Pressure | Change in Office Systolic Blood Pressure after 12 weeks of treatment | Baseline and 12 weeks | |
Secondary | Change in Ambulatory Systolic Blood Pressure | Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment | Baseline and 12 weeks | |
Secondary | Change in weight | Change in body weight | Baseline and 12 weeks | |
Secondary | Change in arterial stiffness | Change in arterial stiffness measured by Sphygmocor device | Baseline and 12 weeks | |
Secondary | Change in left ventricular hypertrophy | Change in left ventricular hypertrophy measured by Echocardiogram | Baseline and 12 weeks | |
Secondary | Change in microalbuminuria | Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio | Baseline and 12 weeks |
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