Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2020-04-01

Brief Summary

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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

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Detailed Description

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* 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.

Conditions

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Renal Function Disorder Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dapaglifozin

People undergoing SGLT2i (Dapaglifozin) therapy

Group Type EXPERIMENTAL

Dapagliflozin 10 MG

Intervention Type DRUG

SGLT2-inhibitor: Diabetic oral drug with diuretic properties

Hydrochlorothiazide

People undergoing thiazide (Hydrochlorothiazide) therapy

Group Type EXPERIMENTAL

Hydrochlorothiazide 12.5mg

Intervention Type DRUG

Best known thiazide class diuretic.

Interventions

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Dapagliflozin 10 MG

SGLT2-inhibitor: Diabetic oral drug with diuretic properties

Intervention Type DRUG

Hydrochlorothiazide 12.5mg

Best known thiazide class diuretic.

Intervention Type DRUG

Other Intervention Names

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DAPA HCT

Eligibility Criteria

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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