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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veterans Medical Research Foundation
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH); San Diego Veterans Healthcare System; University of California, San Diego

Criteria

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