Expired Study
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San Diego, California 92161


Purpose:

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


Study summary:

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.


Criteria:

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/m2 - 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


NCT ID:

NCT02330276


Primary Contact:

Principal Investigator
Robert R Henry, MD
San Diego Veterans Healthcare System


Backup Contact:

N/A


Location Contact:

San Diego, California 92161
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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