Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

• Status: Active, not recruiting
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pisa
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin; Diuretics; Hydrochlorothiazide

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