Clinical trial to evaluate biomarkers of vascular aging

Phase 1

• Conditions: PREDIABETES; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]; MedDRA version: 20.0Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861

• Registration Number: EUCTR2018-000650-21-ES
• Lead Sponsor: niversidad Autónoma de Madrid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-14
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified