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Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy (PURITY)

U

University of Pisa

Status and phase

Unknown
Phase 4

Conditions

Glucose Metabolism Disorders
Renal Function Disorder

Treatments

Drug: Dapagliflozin 10 MG
Drug: Hydrochlorothiazide 12.5mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04242758
PURITY - Protcol 5

Details and patient eligibility

About

In this open clinical trial, 30 subjects with inadequately controlled T2D and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor vs other oral-antidiabetic drugs (OADs) therapy for 3 months. Measures will be performed at baseline, after 2 days, after one month and at the end of the study protocol, as per good clinical practice

Full description

  • 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.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Individuals of both sex;
  • Age between 18 and 85 years;
  • T2D
  • T2D duration > 6 months
  • BMI ≤ 40 Kg/m2,
  • HbA1c > 48 mmol/mol
  • Eligible for SGLT-2i therapy

Exclusion criteria

  • age >85 years,
  • eGFR <60 ml/min/1.73 m2,
  • occurring acute complications

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Dapaglifozin
Experimental group
Description:
People undergoing SGLT2i (Dapaglifozin) therapy
Treatment:
Drug: Dapagliflozin 10 MG
Hydrochlorothiazide
Experimental group
Description:
People undergoing thiazide (Hydrochlorothiazide) therapy
Treatment:
Drug: Hydrochlorothiazide 12.5mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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