subjects with fasting glycemia between 100 and 125 mg/dL MedDRA version: 9.1 Level: SOC Classification code 10027433
Conditions
Interventions
Trade Name: GLUCOSIO SCL.D*OS SCIR 50%150M
Pharmaceutical Form: Syrup
INN or Proposed INN: Glucose
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 75-
Sponsors
ISTITUTO NAZIONALE DI RICOVERO E CURA PER ANZIANI IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: subjects between 35 and 75 years, men and women, subjects with fasting glucose between 100 and 125 mg/dL 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diabetes, Acute illnesses, treatment with life-saving drugs, treatment with drugs that interfering with glucose tolerance, women with known or suspected pregnancy or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the reproducibility of the oral glucose tolerance test (OGTT) following the recommendations elaborated by the Italian joint Study Group on Diabetes Mellitus;Secondary Objective: a) to study the reproducibility of test in different centers b) determination of biological variability;Primary end point(s): Analysis of reproducibility or degree of accordance that a viewer has with himself in two different occasions of OGTT test by comparison between values of two-hours post-load blood glucose for each of the three participating centers | — |
Countries
Italy
Outcome results
None listed