EUCTR2019-002262-12-ES
Active, Not Recruiting
Phase 1
Effect of dapagliflozin on glomerular hyperfiltration in nondiabeticobese patients with or without treatment with ACEIs.Pilot clinical trial of efficacy, low level of intervention, unicentric,randomized and simple blind. - DAPA-OB
Hospital Universitari Germans Trias i Pujol0 sites60 target enrollmentSeptember 1, 2021
ConditionsThis study aims to demonstrate the hypothesis that treatment with dapagliflozin 10mg lowers in at least 10-20% of measured glomerular filtration rate (mGFR) in non-diabetic obese patients with glomerular hyperfiltration.Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
DrugsEdistride
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- This study aims to demonstrate the hypothesis that treatment with dapagliflozin 10mg lowers in at least 10-20% of measured glomerular filtration rate (mGFR) in non-diabetic obese patients with glomerular hyperfiltration.
- Sponsor
- Hospital Universitari Germans Trias i Pujol
- Enrollment
- 60
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age \=18 and \=70 years
- •2\) Diagnosis of obesity (body mass index \=30 Kg/m²)
- •3\) Diagnosis of measured glomerular hyperfiltration (mGFR \=
- •120mL/min) by clearance of iohexol.
- •4\) Understanding and accepting the clinical trial and willing to sign
- •informed consent
- •5\) Twenty of the 60 subjects included must be on a stable dose of
- •angiotensin converting enzyme inhibitors (ACEI) for at least 4 weeks
- •prior to randomization.
- •6\) Women of Child\-Bearing Potential (WOCBP: women who have
Exclusion Criteria
- •1\) Not complying inclusion criteria.
- •2\) Diagnosis of type 1 or type 2 Diabetes Mellitus.
- •3\) History of severe hypersensitivity or contraindications to
- •dapagliflozin.
- •4\) Lactose intolerance or glucose\-galactasa malabsorption.
- •5\) Treatment a month prior clinical trial beginning of any oral
- •antidiabetic.
- •6\) Autosomal dominant polycystic kidney disease or autosomal recessive
- •polycystic kidney disease, lupus nephritis, or ANCA\-associated vasculitis.
- •7\) Receiving cytotoxic therapy, immunosuppressive therapy, or other
Outcomes
Primary Outcomes
Not specified
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