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Association Between Phthalates Exposure and Renal Function Impairment in TYpe 2 Diabetes (PURITY-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03622957
Recruitment Status : Unknown
Verified August 2018 by Anna Solini, University of Pisa.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 10, 2018
Istituto di Fisiologia Clinica CNR
Information provided by (Responsible Party):
Anna Solini, University of Pisa

Brief Summary:

The global incidence of diabetic nephropathy (DN) is increasing, with no appreciable reduction in the percent of patients progressing toward end stage renal disease (ESRD) and dialysis (Tuttle et al, 2014, Winocour et al, 2018). Therefore, identification of modifiable risk factors and early biomarkers of progressive decline in kidney function is an urgent clinical need. Phthalates are environmental and dietary contaminants with a various array of use that are identified in many consumer and industrial products; among them, di-(2-ethylhexyl) phthalate (DEHP) and its metabolites (mono 2-ethylhexyl phthalate (MEHP), 5OH-MEHP (MEHHP) and 5oxo-MEHP (MEOHP)) are widely used (Kato et al 2004, Braun et al, 2013). They partially distribute to the human tissues and their urinary and serum levels are directly related; therefore, urinary concentration of phthalates is commonly used as proxy of their exposure in humans (Kato et al 2004).

While the association between phthalates exposure and development of T2D is currently being explored (Dong et al 2017, Dales et al, 2018), little is known about their role in DN. Recent observations show that DEHP and its metabolites are associated with a higher prevalence of low-grade albuminuria and in children exposed to higher phthalates concentrations (Trasande et al, 2014, Wu et al, 2018), however such association has yet to be verified in adults. The environmental ubiquity of the phthalates enhances the importance of investigating the potential relation between their exposure and different degrees of renal function. (Kato et al 2004, Kataria et al, 2015).

Given this premise, the investigators will explore this potential association in a population of subjects with T2D consecutively referring to the outpatient diabetes clinic in Santa Chiara Hospital, Pisa, enrolled on a volunteer basis. During their routine visit at Santa Chiara Hospital outpatient diabetes clinic participants will provide the results of blood tests prescribed as per standard clinical practice along with a first morning, overnight fasting, urine sample collected in a phthalates-free container.

The investigators will record the participants' clinical history, physical examination and anthropometric measurements, will measure their renal function, evaluated by eGFR (calculated with the CDK-EPI formula), albumin excretion, fasting glucose, HbA1c%, and the exposure to phthalates, assessed by total concentrations of MEHP, MEOHP, MEHHP and adjusted for urinary creatinine. In this way, the investigators aim to point out the relationship of urinary phthalates with higher degrees of albuminuria and/or lower eGFR after adjustment for all potential confounders, including therapies.

Condition or disease
Diabetes Mellitus, Type 2 Albuminuria Cardiovascular Risk Factor

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Exploring the Association Between Phthalates Exposure, Measured Through Their Urinary Metabolites, and Renal Function Impairment in Individuals With TYpe 2 Diabetes - Protocol 2
Estimated Study Start Date : August 10, 2018
Estimated Primary Completion Date : September 3, 2018
Estimated Study Completion Date : September 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Type 2 diabetes subjects
Type 2 diabetes subjects consecutively referring to Santa Chiara, Pisa diabetes outpatients clinic

Primary Outcome Measures :
  1. Phthalates exposure [ug/g] [ Time Frame: Single routine clinical visit ]
    Concentrations of metabolites of DEHP [ug/ml] in a first morning spot urine sample (obtained during clinical visit) measured by ultra-HPLC coupled with electrospray ionization/quadrupole time-of-flight MS and then normalized for urinary creatinine [g/ml].

  2. Albuminuria [mg/g] [ Time Frame: Single routine clinical visit ]
    Grade of albuminuria measured by albuminuria/creatininuria ratio [mg/g] in a first morning spot urine sample (obtained during clinical visit).

  3. Glomerular Filtration Rate [ml/min/1.73m2] [ Time Frame: Single routine clinical visit ]
    GFR measured by eGFR (calculated with CDK-EPI formula). Creatinine [mg/dL] is measured in a serum sample (obtained during clinical visit). Physiological parameters (age, sex, race) are obtained during clinical visit.

Secondary Outcome Measures :
  1. CV Events (Yes/No) [ Time Frame: Single routine clinical visit ]
    History of cardiovascular events (Non fatal: Acute Myocardial infarction, Unstable Angina, Stroke), evaluated by clinical interview during routine clinical visit.

Biospecimen Retention:   Samples Without DNA
First morning spot urine sample

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Type 2 diabetes individuals referring to our outpatient clinics

Inclusion Criteria:

Age 18-85 years, T2D diagnosis, T2D duration >6 months,

Exclusion Criteria:

occurring acute clinical conditions, eGFR <15 ml/min/1.73m2, BMI > 40 Kg/m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03622957

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Contact: Anna Solini, Associate Professor, MD, PhD +39 050993482 anna.solini@med.unipi
Contact: Alessandro Mengozzi, MD + 39050993640

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University of Pisa
Pisa, Italy, 56125
Contact: Anna Solini, Associate Professor, MD, PhD    +39 050993482   
Contact: Alessandro Mengozzi, MD    +39 050993640   
Principal Investigator: Anna Solini, Associate Professor, MD, PhD         
Sub-Investigator: Amalia Gastaldelli, Associate Professor, PhD         
Sub-Investigator: Alessandro Mengozzi, MD         
Sponsors and Collaborators
University of Pisa
Istituto di Fisiologia Clinica CNR

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anna Solini, Associate Professor, MD, PhD, University of Pisa Identifier: NCT03622957    
Other Study ID Numbers: PURITY - Protocol 2
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations