Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors
NCT ID: NCT03917758
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-10-10
2020-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* knowing effect of SGLT2i on RAAS (drugs interferences are important particularly during case detection of primary aldosteronism);
* discovering antidiuretic response to SGLT2i treatment and interactions between RAAS, BNP and ADH on the volume improvement induced by this new antidiabetic drugs.
In addition the aim of the study is to define effect of treatment on blood pressure and body composition.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diabetic patients
30 diabetic patients candidate to treatment with SGLT2i in add-on to metformin.
SGLT2 inhibitor
Start of the treatment with SGLT2i.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SGLT2 inhibitor
Start of the treatment with SGLT2i.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* clinical indication to SGLT2i therapy.
Exclusion Criteria
* HbA1c \>10% or 86 mmol/mol;
* Body Mass Index (BMI) \> 40 Kg/m2;
* personal history of primary and secondary aldosteronism;
* personal history of heart failure;
* personal history of acute kidney injury;
* personal history of chronic kidney disease;
* personal history of liver cirrhosis;
* personal history of protein-wasting syndrome;
* personal history of renin secreting tumor;
* personal history of diabetes insipidus;
* personal history of syndrome of inappropriate antidiuresis (SIAD);
* personal history of hypocortisolism and hypercortisolism;
* therapy with Angiotensin Converting Enzyme inhibitors;
* therapy with Angiotensin Receptor Blockers;
* therapy with renin inhibitors;
* therapy with beta-blockers;
* therapy with alfa2-receptors agonists;
* therapy with Calcium Channel Blockers;
* therapy with diuretics;
* therapy with mineralocorticoid receptor antagonists;
* therapy with non steroidal and steroidal anti-inflammatory drugs.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Turin, Italy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mauro Maccario
Medical Doctor, Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mauro M Maccario, MD
Role: PRINCIPAL_INVESTIGATOR
Endocrinology, Diabetology and Metabolism; University of Turin
Ezio E Ghigo, MD
Role: STUDY_CHAIR
Endocrinology, Diabetology and Metabolism; University of Turin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mauro Maccario
Turin, Piedmont, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Reed JW. Impact of sodium-glucose cotransporter 2 inhibitors on blood pressure. Vasc Health Risk Manag. 2016 Oct 27;12:393-405. doi: 10.2147/VHRM.S111991. eCollection 2016.
Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127. Epub 2013 Jun 5.
Shin SJ, Chung S, Kim SJ, Lee EM, Yoo YH, Kim JW, Ahn YB, Kim ES, Moon SD, Kim MJ, Ko SH. Effect of Sodium-Glucose Co-Transporter 2 Inhibitor, Dapagliflozin, on Renal Renin-Angiotensin System in an Animal Model of Type 2 Diabetes. PLoS One. 2016 Nov 1;11(11):e0165703. doi: 10.1371/journal.pone.0165703. eCollection 2016.
Cherney DZ, Perkins BA, Soleymanlou N, Maione M, Lai V, Lee A, Fagan NM, Woerle HJ, Johansen OE, Broedl UC, von Eynatten M. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation. 2014 Feb 4;129(5):587-97. doi: 10.1161/CIRCULATIONAHA.113.005081. Epub 2013 Dec 13.
Boertien WE, Riphagen IJ, Drion I, Alkhalaf A, Bakker SJ, Groenier KH, Struck J, de Jong PE, Bilo HJ, Kleefstra N, Gansevoort RT. Copeptin, a surrogate marker for arginine vasopressin, is associated with declining glomerular filtration in patients with diabetes mellitus (ZODIAC-33). Diabetologia. 2013 Aug;56(8):1680-8. doi: 10.1007/s00125-013-2922-0. Epub 2013 Apr 28.
Nogueira-Silva L, Blanchard A, Curis E, Lorthioir A, Zhygalina V, Bergerot D, Baron S, Amar L, Bobrie G, Plouin PF, Menard J, Azizi M. Deciphering the Role of Vasopressin in Primary Aldosteronism. J Clin Endocrinol Metab. 2015 Sep;100(9):3297-303. doi: 10.1210/JC.2015-2007. Epub 2015 Jul 10.
Pikkemaat M, Melander O, Bengtsson Bostrom K. Association between copeptin and declining glomerular filtration rate in people with newly diagnosed diabetes. The Skaraborg Diabetes Register. J Diabetes Complications. 2015 Nov-Dec;29(8):1062-5. doi: 10.1016/j.jdiacomp.2015.07.006. Epub 2015 Jul 9.
DeFronzo RA, Hompesch M, Kasichayanula S, Liu X, Hong Y, Pfister M, Morrow LA, Leslie BR, Boulton DW, Ching A, LaCreta FP, Griffen SC. Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):3169-76. doi: 10.2337/dc13-0387. Epub 2013 Jun 4.
Berton AM, Parasiliti-Caprino M, Prencipe N, Bioletto F, Lopez C, Bona C, Caputo M, Rumbolo F, Ponzetto F, Settanni F, Gasco V, Mengozzi G, Ghigo E, Grottoli S, Maccario M, Benso AS. Copeptin adaptive response to SGLT2 inhibitors in patients with type 2 diabetes mellitus: The GliRACo study. Front Neurosci. 2023 Mar 20;17:1098404. doi: 10.3389/fnins.2023.1098404. eCollection 2023.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GliRACo 1
Identifier Type: -
Identifier Source: org_study_id