PREDIABETES MedDRA version: 20.0 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Dianben 850 mg
Product Name: METFORMINA
Pharmaceutical Form: Compressed lozenge
INN or Proposed INN: METFORMIN
CAS Number: 657-24-9
Sponsors
Universidad Autónoma de Madrid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 60 years 2. That meets at least one of the following prediabetes criteria: a.Basal glucose between 100 and 125 mg / dl repeated twice, or b.Glycemia between 140 and 199 mg / dl at two hours of the oral glucose tolerance test of 75 grams, c. Glycosylated hemoglobin (HbA1c) between 5.7 and 6.4% 3. Obesity grade II or higher (BMI = 35 kg / m2). 4. Patient agrees to participate in the study by signing informed consent. 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who are receiving some hypoglycemic treatment 2. Patients with severe hepatic or renal insufficiency; NYHA grade III or IV heart failure or neoplastic processes, except basal cell carcinoma . 3. Patients who for any reason should not be included in the study according to the evaluation of the research team. 4. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify biomarkers of endothelial dysfunction in prediabetic patients and their evolution over time depending on whether they are receiving pharmacological treatment or not. Specifically, we will evaluate IL1-ß, visfatin / Nampt, sDPP4 and klotho as plasma biomarkers.;Secondary Objective: 1. Evaluate the evolution of hyperglycemia (basal glycemia, glycosylated hemoglobin, oral glucose tolerance curve). 2.Determine changes in the parameters of cardiovascular (weight, BMI) and analytical (glycemia, HbA1c and lipid profile) and their correlation with the plasma levels of the different biomarkers. 3. Determine the rate of adverse events. 4.Determine the correlation between levels of plasma biomarkers and the levels of inflammation and senescence in mononuclear cells of patients. 5. Analyze the direct effect of IL1-ß, visfatin / Nampt, sDPP4 and klotho on mononuclear cells isolated from a control group of healthy volunteers.;Primary end point(s): Validate visfatin / Nampt, sDPP4, IL6 (as an indirect marker of IL-1ß) and klotho as biomarkers of endothelial dysfunction in prediabetic patients and their evolution over time as they are receiving pharmacological treatment or not.;Timepoint(s) of evaluation of this end point: Month 0, 12 y 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evolution of prediabetes parameters (basal glycaemia, glycosylated hemoglobin, oral glucose tolerance curve). • Changes in the cardiovascular risk assessment variables and their correlation with the plasma levels of the different biomarkers to be evaluated: - Weight, BMI, waist circumference, blood pressure - Analytics: Glycemia, HbA1c, insulinemia, lipid profile, HOMA-IR index - Glucose during oral glucose tolerance curve;Timepoint(s) of evaluation of this end point: Month 0, 12 y 24 | — |
Countries
Spain
Contacts
Public ContactELENA BERMEJO-UCICEC
HOSPITAL UNIVERSITARIO LA PAZ
Outcome results
None listed