UnknownPhase 4

Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

Italy30 participantsStarted 2019-06-04

Plain-language summary

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

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Urinary Phthalates concentration

Timeframe: Changes between baseline and 1 month

Urinary Phthalates concentration

Timeframe: Changes between baseline and 3 month

Trial details

NCT IDNCT04242758

SponsorUniversity of Pisa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-30

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