Prediabetes
Conditions
Keywords
prediabetes, blood glucose, clinical trial
Brief summary
The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose. The investigators measures changes in diabetes associated parameters, including fasting blood glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.
Interventions
DIETARY_SUPPLEMENTPersimmon leaf extract
Persimmon leaf extract (PLE), crossover design
DIETARY_SUPPLEMENTPlacebo
Placebo, crossover design
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 20-75 years * Fasting blood glucose (FPG) 100\ 140 mg/dL or postprandial blood glucose (PPG) 140\ 250 mg/dL
Exclusion criteria
* FPG more than 140 mg/dL * 2h PPG more than 200 mg/dL * Type 1 diabetes or HbA1c more than 9.0% * treatment with corticosteroids within the past 4 weeks * cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting and postprandial plasma glucose | baseline day 57, 85 and 141 |
Secondary
| Measure | Time frame |
|---|---|
| C-peptide | baseline and day 57, 85 and 141 |
| Glycated hemoglobin (HbA1c) | baseline and day 57, 85 and 141 |
| adiponectin | baseline and day 57, 85 and 141 |
| leptin | baseline and day 57, 85 and 141 |
| Fasting plasma insulin | baseline and day 57, 85 and 141 |
| Markers of Inflammation | baseline and day 57, 85 and 141 |
| Tumor necrosis factor alpha (TNF-α) | baseline and day 57, 85 and 141 |
| Interleukin-6 (IL-6) | baseline and day 57, 85 and 141 |
| Monocyte chemoattractant protein-1 (MCP-1) | baseline and day 57, 85 and 141 |
| resistin | baseline and day 57, 85 and 141 |
Outcome results
None listed