Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)

This will be a double-blind, randomized, placebo-controlled, single dose study of (+)- epicatechin with one 30mg dose/day for a total of 7 days

This project is a double-blinded, placebo-controlled, randomized, Phase I study that will include (+)-epicatechin dosing over seven days.

• Subjects will meet the American Diabetes Association (ADA) criteria for pre-diabetes, including impaired fasting glucose (IFG) [refer to inclusion/exclusion criteria].
• The Project includes: 7 day evaluation of a single daily dose of synthetic (+)-epicatechin in pre-diabetic individuals as compared to placebo.
• The Project has 4 outpatient clinic study visits: screening (Visit 1), randomization (Visit 2), end of study drug (Visit 3), follow up end of study (Visit 4).
• This Project has 2 telephone visits

Primary hypothesis: As these studies are designed to evaluate safety and tolerability, there is no primary hypothesis to test.

Primary outcome measures. Vital signs and safety labs: BP, HR, creatinine, alkaline phosphatase, and liver transaminases

These studies will provide initial data about if (+)-epicatechin can influence glycemic control in individuals with prediabetes.

Inclusion Criteria:

• Pre-diabetic based on medical history and screening results
• 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 female 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 prior to screening
• Body Mass Index (BMI) > 27 kg/m2
• Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and/OR 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 upper limit of normal (ULN)), determined in the last 6 months by a certified clinical laboratory
• Recent myocardial infarct 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