Type 2 Diabetes Mellitus Clinical Trial
— NATRIURETICOfficial title:
Incretin and Treatment With Inhibition of Sodium-glucose Cotransporter-2 Combination Insights Into Mechanisms Implicated in Congestive Heart Failure: "NATRIURETIC" Trial
This study aims to provide essential mechanistic insights into natriuretic and hemodynamic effects of SGLT2i and GLP-1RA agents in T2D patients. Ultimately, by obtaining physiological data in T2D patients without HF, our aims are to gain insight into how the use of this combined therapy may be used in T2D with HF in future work.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Men and women diagnosed with T2D =6 months prior to informed consent; 2. eGFR =30 mL/min/1.73m2; 3. Age >18 years; 4. HbA1c 7.0%-12.0%; 5. Body Mass Index (BMI) 18.5-40.0 kg/m2; 6. Stable HbA1c, measured 2-12 months prior to screening, within 5% of baseline value; 7. Blood pressure =160/100 mmHg at screening, >90/60 mmHg; 8. Stable on dose of ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 2 weeks. Exclusion Criteria: 1. Type 1 Diabetes; 2. Leukocyte and/or nitrite positive urinalysis that is untreated; 3. Severe hypoglycaemia within 2 months prior to screening; 4. History of hypoglycaemia unawareness based on investigator judgement; 5. Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months; 6. Clinically significant valvular disease subject to PI/Sub PI's discretion; 7. Congestive heart failure subject to PI/Sub PI's discretion; 8. Bariatric surgery or other surgeries that induce chronic malabsorption within one year; 9. Anti-obesity drugs or diet regimen and unstable body weight three months prior to screening; 10. Treatment with systemic corticosteroids; 11. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells; 12. Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control; 13. Participation in another trial with an investigational drug within 30 days of informed consent; 14. Alcohol or drug abuse within three months prior to informed consent that would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement; 15. Liver disease, defined by serum levels of alanine transaminase, aspartate transaminase, or alkaline phosphatase >3 x upper limit of normal as determined during screening; 16. Medical history of cancer or treatment for cancer in the last five years prior to screening; 17. History of pancreatitis; 18. Personal of family history of medullary thyroid cancer or MEN2B; 19. Tachycardia, HR >100; 20. Use of SGLT2i, GLP-1RA or DPP-4i within the past 1 month (1-month minimum washout is allowed); 21. History of gastroparesis; 22. Known intolerance to SGLT2i or GLP-1RA; 23. Allergy to iodine-based substances if receiving iohexol for GFR measures. |
Country | Name | City | State |
---|---|---|---|
Canada | Renal Physiology Laboratory | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proximal tubular natriuresis | Measured by fractional excretion of sodium | up to 12 weeks | |
Secondary | Glomerular Filtration Rate | GFR | Glomerular Filtration Rate (GFR, based on plasma iohexol clearance) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks) | |
Secondary | Systolic blood pressure | SBP | Systolic blood pressure (SBP) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks) | |
Secondary | Body weight | Kilograms | Body weight will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks) | |
Secondary | Arterial stiffness | Measured using a Sphygmocor device | Arterial stiffness will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks) | |
Secondary | Systemic vascular resistance | Measured using non-invasive cardiac output monitor (NICOM) | Systemic vascular resistance will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks) | |
Secondary | Urinary concentration of the renin-angiotensin aldosterone system (RAAS) markers | Measured using ELISA | Outcome will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks) | |
Secondary | Urinary EGF,FGF2,Eotaxin,TGFa,G-CSF,Flt-3L,GM-CSF,Fractalkine,IFNa2,IFNy,GRO,IL10,MCP-3,IL-12P40,MDC,IL-12P70,PDGF-AA,IL-13,PDGF-BB,IL-15,sCD40L,IL-17A,IL-1RA,IL1a,IL9,IL1B,IL2,IL3,IL4,IL5,IL6,IL7,IL8,IL10,MCP-1,MIP-1a,MIP-1B,RANTES,TNFalpha,TNFB,VEGF | 41-plex chemo/chemokine profile assay: urinary | Outcome will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks) |
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