Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

NCT04242758 | Unknown Phase 4 DMC

• 1 other identifier: PURITY - Protcol 5
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Renal Function Disorder; Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (2)

• Urinary Phthalates concentration

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

  Changes between baseline and 1 month

• Urinary Phthalates concentration

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

  Changes between baseline and 3 month

Secondary Outcomes (5)

• Fasting glucose

  1 and 3 months

• Glycated Haemoglobin

  1 and 3 months

• Renal function

  1 and 3 months

• Macrovascular events

  1 and 3 months

• Albumin excretion

  1 and 3 months

Study Arms (2)

Dapaglifozin

EXPERIMENTAL

People undergoing SGLT2i (Dapaglifozin) therapy

Drug: Dapagliflozin 10 MG

Hydrochlorothiazide

EXPERIMENTAL

People undergoing thiazide (Hydrochlorothiazide) therapy

Drug: Hydrochlorothiazide 12.5mg

Interventions

Dapagliflozin 10 MG DRUG

SGLT2-inhibitor: Diabetic oral drug with diuretic properties

Also known as: DAPA

Dapaglifozin

Hydrochlorothiazide 12.5mg DRUG

Best known thiazide class diuretic.

Also known as: HCT

Hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 56125, Italy

Location

Related Publications (7)

• 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.

  PMID: 28898934 BACKGROUND

• 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.

  PMID: 22498808 BACKGROUND

• 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.

  PMID: 30462244 BACKGROUND

• 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.

  PMID: 14998748 BACKGROUND

• 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.

  PMID: 15579421 BACKGROUND

• 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.

  PMID: 28756396 BACKGROUND

• 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.

  PMID: 31669154 BACKGROUND

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

dapagliflozin; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Solini, Prof

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: June 4, 2019
• Primary Completion: December 30, 2019
• Study Completion: April 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)