Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)
Conditions
Brief summary
The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).
Interventions
DRUGRubus occidentalis extract
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 years of age or older * prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)
Exclusion criteria
* pregnant women * taking anti-hyperglycemic agents within 3 months at the time of enrollment * history of heart failure, myocardial infarction, cerebral infarction * uncontrolled hypertension (systolic BP \> 160mmHg, or diastolic BP \> 100mmHg) * serum triglyceride level \> 500mg/dl * kidney dysfunction (serum Creatinine \> 30% of upper normal limits) * hepatic dysfunction (AST, ALT \> 3 times of upper normal limits) * taking systemic glucocorticoids within 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum glucose (fasting and post 75g oral glucose tolerance test) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| serum insulin | 12 weeks |
Other
| Measure | Time frame |
|---|---|
| HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers | 12 weeks |
Outcome results
None listed