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

Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Age Range:21 - 75
Start Date:September 2015
End Date:August 2016
Contact:Robert R Henry, MD

Use our guide to learn which trials are right for you!

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
We found this trial at
3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
Phone: 858-552-8585
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92161
Principal Investigator: Robert R. Henry, M.D.
Phone: 858-642-3648
San Diego, CA
Click here to add this to my saved trials