Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

Sponsor
University of Pisa
Study ID
NCT04242758
Phase
PHASE4
Status
Unknown

Conditions

  • Glucose Metabolism Disorders
  • Renal Function Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG — DRUG
    SGLT2-inhibitor: Diabetic oral drug with diuretic properties
  • Hydrochlorothiazide 12.5mg — DRUG
    Best known thiazide class diuretic.

Study Details

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

Key Dates

Start date
Jun 4, 2019
Status verified
Jan 2020
Primary completion
Dec 30, 2019
Completion
Apr 1, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Dapaglifozin
    People undergoing SGLT2i (Dapaglifozin) therapy
  • Experimental: Hydrochlorothiazide
    People undergoing thiazide (Hydrochlorothiazide) therapy

Primary Outcome Measure

Urinary Phthalates concentration [ Time Frame: Changes between baseline and 1 month ]

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