Diabetes Mellitus, Type 2GliRACo1NCT03917758
Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors
A study testing SGLT2 inhibitor in people with Diabetes Mellitus, Type 2 and Arterial Hypertension, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Subjects treated with Canagliflozin, Dapagliflozin and Empagliflozin obtained improvement on blood pressure values, body weight and cardiovascular mortality but pathophysiological explanations of these effects are not yet known. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Arterial Hypertension, Body Weight Changes
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2018to 30 Oct 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic patients;
- clinical indication to SGLT2i therapy.
Who cannot join
- signs and symptoms of poor glycemic control (polydipsia, polyuria and weight loss);
- 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;
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Mauro Maccario
Turin, Piedmont, 10126
Mauro M Maccario, MD, 00390116709559, mauro.maccario@unito.it
Mirko M Parasiliti Caprino, MD, PhD, 00390116335544, mirko.parasiliticaprino@unito.it
About this study
Official title: Assessment of the Renin-angiotensin-aldosterone System (RAAS) and Antidiuretic Function in Patients With Type 2 Diabetes Before and During Treatment With Sodium-glucose Co-transporter 2 Inhibitors (SGLT2i): the GliRACo 1 Study
Subjects treated with Canagliflozin, Dapagliflozin and Empagliflozin obtained improvement on blood pressure values, body weight and cardiovascular mortality but pathophysiological explanations of these effects are not yet known.
Read the detailed description
The pathophysiological explanations of the cardiovascular improvement of patients treated with SGLT2i are not yet known: osmotic diuresis and natriuresis, direct effects of weight reduction, increased in nitric oxide release, oxidative stress reduction, local renin-angiotensin-aldosterone system (RAAS) inhibition are the supposed mechanism. In the Literature the diuretic effect of SGLT2i therapy seems to be even stronger than thiazide or thiazide-like drugs. However, it is not defined the role of SGLT2i on antidiuretic function (RAAS, brain natriuretic peptide-BNP and antidiuretic hormone-ADH). Defining this relation could be important for:
- 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.
- Being tested
- SGLT2 inhibitor
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Renin-Angiotensin System, Vasopressin, Natriuretic Peptide, Brain, Blood Pressure, Body Composition, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Body Weight Changes, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called Dapagliflozin, Empagliflozin, Canagliflozin
Start of the treatment with SGLT2i.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Experimental | 30 diabetic patients candidate to treatment with SGLT2i in add-on to metformin. Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of antidiuretic function parameters (BNP)
Blood samples for BNP (pg/mL).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (BNP)
Blood samples for BNP (pg/mL).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (vasopressin)
Blood samples for Copeptin (pmol/L).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (vasopressin)
Blood samples for Copeptin (pmol/L).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for plasma osmolality (mOsm/Kg).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for urinary osmolality (mOsm/Kg).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for plasma osmolality (mOsm/Kg).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for urinary osmolality (mOsm/Kg).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for serum sodium (mmol/L).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for serum sodium (mmol/L).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for urinary sodium (mmol/L).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for urinary sodium (mmol/L).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for serum potassium (mmol/L).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for serum potassium (mmol/L).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for urinary potassium (mmol/L).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for urinary potassium (mmol/L).
Measured: 90 days after starting SGLT2i therapy
Changes from baseline of renin-angiotensin-aldosterone system parameters (renin)
Blood samples for plasma renin activity (ng/mL/h).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of renin-angiotensin-aldosterone system parameters (renin)
Blood samples for plasma renin activity (ng/mL/h).
Measured: 90 days after starting SGLT2i therapy
Long term changes from baseline of renin-angiotensin-aldosterone system parameters aldosterone)
Blood samples for aldosterone (pg/mL).
Measured: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Long term changes from baseline of renin-angiotensin-aldosterone system parameters
Blood samples for plasma renin activity (ng/mL/h) and aldosterone (pg/mL)
Measured: 90 days after starting SGLT2i therapy
Secondary outcomes (4)
Changes from baseline of blood pressure values (ABPM)
Mean Systolic and Diastolic Blood Pressure (mmHg)
Measured: Before starting SGLT2i and 90 days after the starting
Changes from baseline of body composition
Variation of parameters of Bioelectrical Impedance Analysis (BIA)
Measured: Before starting SGLT2i and 90 days after the starting
Changes in basal glicemic control
Blood samples for basal glucose (mg/dL).
Measured: Before starting SGLT2i and 90 days after the starting
Changes in long term glicemic control
Blood samples for Glycated albumin (mmol/mol).
Measured: Before starting SGLT2i and 90 days after the starting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start10 Oct 2018
- Primary completion30 Jul 2020
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Maccario, University of Turin, Italy
- Investigators
- Mauro M Maccario, MD, Principal investigator, Endocrinology, Diabetology and Metabolism; University of TurinEzio E Ghigo, MD, Study chair, Endocrinology, Diabetology and Metabolism; University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917758
- Sponsor's protocol ID
- GliRACo 1
- Acronym
- GliRACo1
- Status last verified
- Nov 2020
- First submitted
- 7 Apr 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27822054Zinman 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.
PubMed 26378978Lambers 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.
PubMed 23668478Shin 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.
PubMed 27802313Cherney 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.
PubMed 24334175Boertien 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.
PubMed 23624546Nogueira-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.
PubMed 26161452Pikkemaat 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.
PubMed 26321369DeFronzo 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.
PubMed 23735727Berton 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.
PubMed 37021137
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Renin-angiotensin-aldosterone System (RAAS) and Antidiuretic Function in Patients With Type 2 Diabetes Before and During Treatment With Sodium-glucose Co-transporter 2 Inhibitors (SGLT2i): the GliRACo 1 Study
- ClinicalTrials.gov ID
- NCT03917758
- Acronym / sponsor ID
- GliRACo1 / GliRACo 1
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Renin-Angiotensin System, Vasopressin, Natriuretic Peptide, Brain, Blood Pressure, Body Composition, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects treated with Canagliflozin, Dapagliflozin and Empagliflozin obtained improvement on blood pressure values, body weight and cardiovascular mortality but pathophysiological explanations of these effects are not yet known.
Detailed description
The pathophysiological explanations of the cardiovascular improvement of patients treated with SGLT2i are not yet known: osmotic diuresis and natriuresis, direct effects of weight reduction, increased in nitric oxide release, oxidative stress reduction, local renin-angiotensin-aldosterone system (RAAS) inhibition are the supposed mechanism. In the Literature the diuretic effect of SGLT2i therapy seems to be even stronger than thiazide or thiazide-like drugs. However, it is not defined the role of SGLT2i on antidiuretic function (RAAS, brain natriuretic peptide-BNP and antidiuretic hormone-ADH). Defining this relation could be important for:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | Experimental | Drug: SGLT2 inhibitor30 diabetic patients candidate to treatment with SGLT2i in add-on to metformin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diabetic patients;
- clinical indication to SGLT2i therapy.
Key exclusion criteria (22 listed)
- signs and symptoms of poor glycemic control (polydipsia, polyuria and weight loss);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorAlso: Dapagliflozin, Empagliflozin, CanagliflozinStart of the treatment with SGLT2i. | Drug | Diabetic patients |
Primary outcome
Changes from baseline of antidiuretic function parameters (BNP)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Blood samples for BNP (pg/mL).
Changes from baseline of antidiuretic function parameters (BNP)
Time frame: 90 days after starting SGLT2i therapy
Blood samples for BNP (pg/mL).
Changes from baseline of antidiuretic function parameters (vasopressin)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Blood samples for Copeptin (pmol/L).
Changes from baseline of antidiuretic function parameters (vasopressin)
Time frame: 90 days after starting SGLT2i therapy
Blood samples for Copeptin (pmol/L).
Changes from baseline of antidiuretic function parameters (osmolality)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Samples for plasma osmolality (mOsm/Kg).
Changes from baseline of antidiuretic function parameters (osmolality)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Samples for urinary osmolality (mOsm/Kg).
Changes from baseline of antidiuretic function parameters (osmolality)
Time frame: 90 days after starting SGLT2i therapy
Samples for plasma osmolality (mOsm/Kg).
Changes from baseline of antidiuretic function parameters (osmolality)
Time frame: 90 days after starting SGLT2i therapy
Samples for urinary osmolality (mOsm/Kg).
Changes from baseline of antidiuretic function parameters (sodium balance)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Samples for serum sodium (mmol/L).
Changes from baseline of antidiuretic function parameters (sodium balance)
Time frame: 90 days after starting SGLT2i therapy
Samples for serum sodium (mmol/L).
Changes from baseline of antidiuretic function parameters (sodium balance)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Samples for urinary sodium (mmol/L).
Changes from baseline of antidiuretic function parameters (sodium balance)
Time frame: 90 days after starting SGLT2i therapy
Samples for urinary sodium (mmol/L).
Changes from baseline of antidiuretic function parameters (potassium balance)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Samples for serum potassium (mmol/L).
Changes from baseline of antidiuretic function parameters (potassium balance)
Time frame: 90 days after starting SGLT2i therapy
Samples for serum potassium (mmol/L).
Changes from baseline of antidiuretic function parameters (potassium balance)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Samples for urinary potassium (mmol/L).
Changes from baseline of antidiuretic function parameters (potassium balance)
Time frame: 90 days after starting SGLT2i therapy
Samples for urinary potassium (mmol/L).
Changes from baseline of renin-angiotensin-aldosterone system parameters (renin)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Blood samples for plasma renin activity (ng/mL/h).
Changes from baseline of renin-angiotensin-aldosterone system parameters (renin)
Time frame: 90 days after starting SGLT2i therapy
Blood samples for plasma renin activity (ng/mL/h).
Long term changes from baseline of renin-angiotensin-aldosterone system parameters aldosterone)
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Blood samples for aldosterone (pg/mL).
Long term changes from baseline of renin-angiotensin-aldosterone system parameters
Time frame: 90 days after starting SGLT2i therapy
Blood samples for plasma renin activity (ng/mL/h) and aldosterone (pg/mL)
4 secondary outcomes
Changes from baseline of blood pressure values (ABPM)
Time frame: Before starting SGLT2i and 90 days after the starting
Changes from baseline of body composition
Time frame: Before starting SGLT2i and 90 days after the starting
Changes in basal glicemic control
Time frame: Before starting SGLT2i and 90 days after the starting
Changes in long term glicemic control
Time frame: Before starting SGLT2i and 90 days after the starting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Results publication: PubMed 27822054Reed 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.
- Results publication: PubMed 26378978Zinman 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.
- Results publication: PubMed 23668478Lambers 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.
- Results publication: PubMed 27802313Shin 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.
- Results publication: PubMed 24334175Cherney 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.
- Results publication: PubMed 23624546Boertien 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.
- Results publication: PubMed 26161452Nogueira-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.
- Results publication: PubMed 26321369Pikkemaat 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.
- Results publication: PubMed 23735727DeFronzo 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.
- Derived from this study: PubMed 37021137Berton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro M Maccario, MD principal investigator
Endocrinology, Diabetology and Metabolism; University of Turin
Ezio E Ghigo, MD study chair
Endocrinology, Diabetology and Metabolism; University of Turin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGLT2 inhibitor in people with Diabetes Mellitus, Type 2 and Arterial Hypertension, run by University of Turin, Italy 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 2 inclusion and 22 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 3 Nov 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.
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?
Contact Mauro M Maccario, MD (00390116709559, mauro.maccario@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline of antidiuretic function parameters (BNP) (time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy). The study lists 20 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 NCT03917758, which also lists 10 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 3 Nov 2020.