Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Pre-diabetes Clinical Trial

— Epicatechin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330276
• Other study ID #: 08847
• Secondary ID: 1R01AT008310-01
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2014
• Last updated: December 10, 2015
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-diabetes

Intervention

Drug:
• (+)-Epicatechin
The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Epicatechin and Metabolites	Levels of epicatechin and metabolites present in circulation and urine.	24 hours	No
Secondary	Adverse Events	Number of Participants with Adverse Events as a Measure of Safety and Tolerability.	9 Days	No