Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

(+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

This project is a double-blinded randomized Phase I study that will include dose-ranging one day PK and pharmacodynamic (PD) studies. Subjects will include healthy individuals and subjects who meet the American Diabetes Association (ADA) criteria for pre-diabetes, including IFG.

Inclusion Criteria:

• Healthy or pre-diabetic based on medical history
• Male or female
• Must be 21 to 75 years of age (inclusive)
• Able to give informed consent to the procedures
• If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included.
• If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
• Medication use stable for 4 weeks
• Body Mass Index (BMI) > 27 kg/m^2
• Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes

Exclusion Criteria:

• Type 2 diabetes
• Pregnancy
• Younger than 21 or older than 75 years of age
• Clinically significant abnormalities in liver or kidney function (>3x ULN), determined in the last 6 months by a certified clinical laboratory
• Recent MI or stroke (within 6 months of screening)
• Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic
• Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs
• Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism