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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapaglifozin | Experimental | People undergoing SGLT2i (Dapaglifozin) therapy |
|
| Hydrochlorothiazide | Experimental | People undergoing thiazide (Hydrochlorothiazide) therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 MG | Drug | SGLT2-inhibitor: Diabetic oral drug with diuretic properties |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Fasting glucose measured in a fasting morning blood sample | 1 and 3 months |
| Glycated Haemoglobin | HbA1c in a fasting measured in a morning blood sample |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anna Solini, Prof | University of Pisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pisa | Pisa | 56125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28898934 | Background | 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. | |
| 22498808 | 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. |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| Hydrochlorothiazide 12.5mg | Drug | Best known thiazide class diuretic. |
|
|
| 1 and 3 months |
| Renal function | Using creatinine measured in a fasting morning blood sample and estimated by eGFR (calculated with the CDK-EPI formula) | 1 and 3 months |
| Macrovascular events | Number of participants with MACE events (Stroke, Acute Myocardial Infarction, Unstable Angina, Revascularization) | 1 and 3 months |
| Albumin excretion | Measured by urinary albumin/creatinine ratio | 1 and 3 months |
| 30462244 | 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. |
| 14998748 | 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. |
| 15579421 | 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. |
| 28756396 | 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. |
| 31669154 | 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. |
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |