2025-12-25
notable
Not Yet Recruiting→Active, Not Recruiting Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Active, Not Recruiting
Start dateestimated 2023-04-01→confirmed 2023-10-31
Enrollment targetestimated 6500→confirmed 2024
Eligibility criteria+1,185 characters
Inclusion Criteria:
Participants aged ≥4540 years (male) or 55 years (female)old
Participants with prediabetes, defined as glycated hemoglobin (HbA1c) between 5.7% and 6.4%
Participants with body mass index>25kg/m2, or abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
Participants with prediabetes,established definedatherosclerosis as:cardiovascular diseases (a) impaired fasting glucose (IFG) (i.e., 6.1 mmol/L≤FPG<7.0
mmol/LASCVD), or (b) impaired glucose tolerance (IGT) (i.e., 7.8mmol/L≤2hPG<11.1 mmol/L)
Participants who meetwith at least two [...] [...]
Secondary endpoints6 to 16 entries
Changes of glycemic-related parameters
Changes of lipid-related parameters
Change of inflammation-related marker
Change of physical examination measures
Changes of other parameters
Change of depressive symptoms
Time to allfirst occurrence of composite endpoint of major cardiovascular event and diabetes
Exploratory biomarker analyses
Time to first occurrence of composite endpoint of major cardiovascular event and diabetes
Time to new-causeonset deathdiabetes
Time to newly diagnosed cancer
Primary endpoints1 entry, revised
TimeThe to first occurrencedistribution of compositeglycemic endpointstatus ofat new-onset1 diabetesyear andafter major cardiovascular events.randomization
Study sitescontacts updated at 1 of 1 site