Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy (PURITY)
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|ClinicalTrials.gov Identifier: NCT04242758|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Renal Function Disorder Glucose Metabolism Disorders||Drug: Dapagliflozin 10 MG Drug: Hydrochlorothiazide 12.5mg||Phase 4|
- Total concentrations of MEHP, MEOHP and MEHHP will be quantified, in the laboratories of the Institute of Clinical Physiology, National Research Council, Pisa, in a spot morning urine sample by ultra-HPLC coupled with electrospray ionization/quadrupole time-of-flight mass spectrometry (Agilent UHPLC 1290 infinity coupled to an Agilent 6540 MS-QTOF, Santa Clara, CA) using stable isotope labeled substrates, i.e. MEHP (ring-1,2-13C2, dicarboxyl-13C2), MEHHP, MEHHP 13C4, MEOHP and MEOHP 13C4 that will be purchased from Cambridge Isotope Laboratories (Tewksbury, MA).
- Urinary creatinine concentrations will be measured to adjust urinary concentrations of DEHP metabolite (Beckman Coulter AU400, Brea, CA), thus minimizing the inﬂuence of urine volume.
- Serum and urinary inflammatory markers and adipocytokines will be quantitatively determined using sandwich enzyme-linked immunosorbent assays kits according to the manufacturer's instructions. Optical density will be measured using a microplate reader.
- Serum and urinary markers of oxidative stress will be measured by gold standard techniques. In detail, MDA will be quantified by TBARS reactive substances measured by optical density; GSH-Px by a specific assay kit according to the manufacturer's instruction; SOD activity will be determined using a specific SOD kit; urinary 8-isoprostane concentration will be measured by a specific affinity sorbent. (Cayman Chemical, Ann Harbor, MI, USA) according to the manufacturer's instructions.
- To analyze mitochondrial DNA we will apply a triplex design previously reported to amplify mitochondria loci located within the MinorArc and MajorArc, respectively. To assess nuclear DNA, we will use RNase P Copy Number Reference.
- The phthalates-free diet will be self-administered by the individuals under intervention, following a set of instruction and rules provided by the physicians based on the current literature data.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploring the Association Between Phthalates Exposure, Measured Through Their Urinary Metabolites, and Renal Function Impairment in Individuals With TYpe 2 Diabetes - SGLT2 Subprotocol|
|Actual Study Start Date :||June 4, 2019|
|Actual Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||April 1, 2020|
People undergoing SGLT2i (Dapaglifozin) therapy
Drug: Dapagliflozin 10 MG
SGLT2-inhibitor: Diabetic oral drug with diuretic properties
Other Name: DAPA
People undergoing thiazide (Hydrochlorothiazide) therapy
Drug: Hydrochlorothiazide 12.5mg
Best known thiazide class diuretic.
Other Name: HCT
- Urinary Phthalates concentration [ Time Frame: Changes between baseline and 1 month ]Exposure to phthalates assessed through urinary concentration of phthalates metabolites spot and 24-hours
- Urinary Phthalates concentration [ Time Frame: Changes between baseline and 3 month ]Exposure to phthalates assessed through urinary excretion spot and 24-hours
- Fasting glucose [ Time Frame: 1 and 3 months ]Fasting glucose measured in a fasting morning blood sample
- Glycated Haemoglobin [ Time Frame: 1 and 3 months ]HbA1c in a fasting measured in a morning blood sample
- Renal function [ Time Frame: 1 and 3 months ]Using creatinine measured in a fasting morning blood sample and estimated by eGFR (calculated with the CDK-EPI formula)
- Macrovascular events [ Time Frame: 1 and 3 months ]Number of participants with MACE events (Stroke, Acute Myocardial Infarction, Unstable Angina, Revascularization)
- Albumin excretion [ Time Frame: 1 and 3 months ]Measured by urinary albumin/creatinine ratio
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242758
|University of Pisa|
|Pisa, Italy, 56125|
|Principal Investigator:||Anna Solini, Prof||University of Pisa|