Effect of the dapagliflozin drug on the glomerular hyperfiltration in nondiabeticobese patients.
- 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.Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2019-002262-12-ES
- Lead Sponsor
- Hospital Universitari Germans Trias i Pujol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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
experienced menarche and who have not undergone successful surgical
sterilization -hysterectomy, bilateral tubal ligation, or bilateral
oophorectomy- or who are not post-menopausal): must be using an
acceptable method of contraception (barrier, hormonal or intra uterine
device) to avoid pregnancy throughout the study and for up to 4 weeks
after the last dose of study drug in such a manner that the risk of
pregnancy is minimized.ç7) WOCBP must have a negative serum or urine pregnancy test result
within 0 to 72 hours before the first dose of study drug.
8) Women must not be breast-feeding.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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
immunotherapy for primary or secondary renal disease within 6 months
prior to enrolment.
8) History of organ transplantation.
9) History of New York Heart Association (NYHA) class IV of cardiac
insufficiency.
10) Miocardial infarction, unstable angina, stroke or transient ischemic
attack within 12 weeks prior to enrolment.
11) Any medication, surgical or medical condition which might
significantly alter the absorption, distribution, metabolism, or excretion
of medications including, but not limited to any of the following:
- History of active inflammatory bowel disease within the last six
months;
- Major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy, or bowel resection;
- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding
within last six months;
- Pancreatic injury or pancreatitis within the last six months;
- Evidence of hepatic disease as determined by any one of the following:
ALT or AST values exceeding 3x ULN at the screening visit, a history of
hepatic encephalopathy, a history of esophageal varices, or a history of
portocaval shunt.
12) History of drug or alcohol abuse within the 12 months prior to
dosing, or evidence of such abuse as indicated by the laboratory assays
conducted during the screening.
13) Active malignancy aside from treated squamous cell or basal cell
carcinoma of the skin.
14) History of > 2 urinary infections within the last year.
15) Pregnancy or breastfeeding.
16) Participation in any clinical investigation within 3 months prior to
initial dosing.
17) History of noncompliance to medical regimens or unwillingness to
comply with the study protocol.
18) Any surgical or medical condition, which in the opinion of the
investigator, may place the patient at higher risk from his/her
participation in the study, or is likely to prevent the patient from
complying with the requirements of the study or completing the study.
19) Treatment with antidiabetic drugs, surgery, aggressive diet regimen
or significant increase of physical exercise leading to unstable body
weight.
19) WOCBP who are unwilling or unable to use an acceptable method to
avoid pregnancy for the entire study period and up to 4 weeks after the
last dose of study drug.
20) Iodized contrast allergy
During the clinical trial, the treatment with concomitant non-steroidal
anti-inflammatory drugs (NSAIDs) will be contraindicated, due to the
risk of acute renal failure as a consequence of an excessive decrease in
renal perfusion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of dapagliflozin on mGFR in non-diabetic obese<br>patients with glomerular hyperfiltration.;Secondary Objective: Moreover, we will study the effect of dapagliflozin on blood pressure,<br>weight, abdominal, proteinuria, hepatic esteatosis, aric ucid, HbA1c,<br>fasting blood glycemia, insulin resistence, aldosterone, renin,<br>angiotensin II and urinary biomarkers.;Primary end point(s): Decrease in at least 10-20% of measured glomerular filtration rate<br>(mGFR) in non-diabetic obese patients with glomerular hyperfiltration<br>after treatment with dapagliflozin 10mg for 6 weeks relative to placebo<br>(Time Frame: week 0, 6).;Timepoint(s) of evaluation of this end point: Follow-up of 6 weeks.
- Secondary Outcome Measures
Name Time Method