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Renal Function DisorderPhase 4PURITYNCT04242758

Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

A Phase 4 study testing Dapagliflozin 10 MG and Hydrochlorothiazide 12.5mg in people with Renal Function Disorder and Glucose Metabolism Disorders, run by University of Pisa at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Dapagliflozin 10 MG and Hydrochlorothiazide 12.5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
4 Jun 2019to 1 Apr 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • age >85 years,
  • eGFR <60 ml/min/1.73 m2,
  • occurring acute complications

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Pisa

    Pisa, 56125

Other trials in Italy

About this study

Official title: Exploring the Association Between Phthalates Exposure, Measured Through Their Urinary Metabolites, and Renal Function Impairment in Individuals With TYpe 2 Diabetes - SGLT2 Subprotocol

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

Read the detailed description
  • 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.
Being tested
Dapagliflozin 10 MG, Hydrochlorothiazide 12.5mg
Medical subject headings
Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin 10 MGDrug

    Also called DAPA

    SGLT2-inhibitor: Diabetic oral drug with diuretic properties

  • Hydrochlorothiazide 12.5mgDrug

    Also called HCT

    Best known thiazide class diuretic.

Study groups in NCT04242758
Study groupRoleWhat they receive
DapaglifozinExperimentalPeople undergoing SGLT2i (Dapaglifozin) therapy
Receives: Drug: Dapagliflozin 10 MG
HydrochlorothiazideExperimentalPeople undergoing thiazide (Hydrochlorothiazide) therapy
Receives: Drug: Hydrochlorothiazide 12.5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary Phthalates concentration

    Exposure to phthalates assessed through urinary concentration of phthalates metabolites spot and 24-hours

    Measured: Changes between baseline and 1 month

  2. Urinary Phthalates concentration

    Exposure to phthalates assessed through urinary excretion spot and 24-hours

    Measured: Changes between baseline and 3 month

Secondary outcomes (5)

  1. Fasting glucose

    Fasting glucose measured in a fasting morning blood sample

    Measured: 1 and 3 months

  2. Glycated Haemoglobin

    HbA1c in a fasting measured in a morning blood sample

    Measured: 1 and 3 months

  3. Renal function

    Using creatinine measured in a fasting morning blood sample and estimated by eGFR (calculated with the CDK-EPI formula)

    Measured: 1 and 3 months

  4. Macrovascular events

    Number of participants with MACE events (Stroke, Acute Myocardial Infarction, Unstable Angina, Revascularization)

    Measured: 1 and 3 months

  5. Albumin excretion

    Measured by urinary albumin/creatinine ratio

    Measured: 1 and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start4 Jun 2019
  3. Primary completion30 Dec 2019
  4. Study completion1 Apr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04242758
Sponsor's protocol ID
PURITY - Protcol 5
Acronym
PURITY
Status last verified
Jan 2020
First submitted
22 Jan 2020
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dales RE, Kauri LM, Cakmak S. The associations between phthalate exposure and insulin resistance, beta-cell function and blood glucose control in a population-based sample. Sci Total Environ. 2018 Jan 15;612:1287-1292. doi: 10.1016/j.scitotenv.2017.09.009. Epub 2017 Sep 8.

    PubMed 28898934

  • Lind PM, Zethelius B, Lind L. Circulating levels of phthalate metabolites are associated with prevalent diabetes in the elderly. Diabetes Care. 2012 Jul;35(7):1519-24. doi: 10.2337/dc11-2396. Epub 2012 Apr 12.

    PubMed 22498808

  • Mengozzi A, Carli F, Biancalana E, Della Latta V, Seghieri M, Gastaldelli A, Solini A. Phthalates Exposure as Determinant of Albuminuria in Subjects With Type 2 Diabetes: A Cross-Sectional Study. J Clin Endocrinol Metab. 2019 May 1;104(5):1491-1499. doi: 10.1210/jc.2018-01797.

    PubMed 30462244

  • Kato K, Silva MJ, Reidy JA, Hurtz D 3rd, Malek NA, Needham LL, Nakazawa H, Barr DB, Calafat AM. Mono(2-ethyl-5-hydroxyhexyl) phthalate and mono-(2-ethyl-5-oxohexyl) phthalate as biomarkers for human exposure assessment to di-(2-ethylhexyl) phthalate. Environ Health Perspect. 2004 Mar;112(3):327-30. doi: 10.1289/ehp.6663.

    PubMed 14998748

  • Hauser R, Meeker JD, Park S, Silva MJ, Calafat AM. Temporal variability of urinary phthalate metabolite levels in men of reproductive age. Environ Health Perspect. 2004 Dec;112(17):1734-40. doi: 10.1289/ehp.7212.

    PubMed 15579421

  • Zota AR, Singla V, Adamkiewicz G, Mitro SD, Dodson RE. Reducing chemical exposures at home: opportunities for action. J Epidemiol Community Health. 2017 Jul 29;71(9):937-40. doi: 10.1136/jech-2016-208676. Online ahead of print.

    PubMed 28756396

  • Frederiksen H, Nielsen O, Koch HM, Skakkebaek NE, Juul A, Jorgensen N, Andersson AM. Changes in urinary excretion of phthalates, phthalate substitutes, bisphenols and other polychlorinated and phenolic substances in young Danish men; 2009-2017. Int J Hyg Environ Health. 2020 Jan;223(1):93-105. doi: 10.1016/j.ijheh.2019.10.002. Epub 2019 Oct 25.

    PubMed 31669154

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin 10 MG and Hydrochlorothiazide 12.5mg in people with Renal Function Disorder and Glucose Metabolism Disorders, run by University of Pisa at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary Phthalates concentration (time frame: Changes between baseline and 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04242758, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

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