Clinical trial to assess the inflammatory and renal parameters in patients with diabetes mellitus type 2 in treatment with empagliflozine

Phase 1

Conditions: Type 2 Diabetes Mellitus
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2017-003779-75-ES

Lead Sponsor: Hospital Universitario La Paz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Patients diagnosed with type 2 DM with poor metabolic control (glycosylated hemoglobin> 6.5%)
2. Patients who have suffered an acute myocardial infarction or who have undergone a coronary revascularization procedure within 30 days prior to the start of the study.
3. Over 18 and under 85
4. Treatment with any hypoglycaemia including insulin.
5. Left ventricular ejection fraction preserved (LVEF> 40%)
6. Patients who have signed their consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Patients with type 1 DM.
2. Previous or current treatment with an SGLT2 inhibitor.
3. Creatinine clearance <60 ml / min / 1.73m2.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to evaluate the effect of treatment with empagliflozin 10 mg daily, on renal and systemic inflammation parameters, in patients with type 2 diabetes mellitus and ischemic heart disease at 6 months of treatment.;Secondary Objective: 1. To evaluate the effect of empagliflozin treatment on renal and systemic inflammation parameters (IL- &, TNF alpha) in patients with type 2 diabetes mellitus with ischemic heart disease at 3 months of treatment.<br><br>2. Study the general situation of the patient including concomitant medication and morbidity.<br>3. Evaluate the continuity of treatment according to the appearance of adverse effects.<br>4. To evaluate specifically the appearance of hypoglycemia and its degree of severity.;Primary end point(s): Main variable: Inflammatory activity determined by PCR, VSG, homocysteine, high sensitivity PCR, IL-6, IL-10, TNF alpha, MCP-1, TGF beta, CTGF, Endothelin 1, angiotensin 2.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. General: Age, sex, height, weight, BMI, time of evolution of DM2, previous macrovascular complications, microvascular complications, blood pressure, heart rate.<br>2. Pharmacological: hypoglycaemic (including insulin), lipid-lowering, antihypertensive, antiplatelet, anticoagulants.<br>3. Hematological: hemoglobin, hematocrit<br>4. Lipid profile: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides<br>5. Cardio-renal: Nt-ProBNP, Cr, urea, proteinuria (albumin / creatinine index), sodium and potassium in urine. Plastic and urinary osmolarity.<br>6. Endocrinological: fasting glucose, HbA1c, peptide c, ketone bodies in urine, ketonemia. Venous gasometry, severe hypoglycemia insulin?<br>7. Markers of oxidative stress: oxidant capacity in urine.;Timepoint(s) of evaluation of this end point: 6 months