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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02330276
First Posted: January 1, 2015
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
San Diego Veterans Healthcare System
University of California, San Diego
Information provided by (Responsible Party):
Robert R. Henry, MD, Veterans Medical Research Foundation
  Purpose
Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.

Condition Intervention Phase
Pre-diabetes Drug: (+)-Epicatechin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: (+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

Resource links provided by NLM:


Further study details as provided by Robert R. Henry, MD, Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites [ Time Frame: Baseline and 24 hours ]
    This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers


Secondary Outcome Measures:
  • Change From Baseline in Major Safety Endpoints [ Time Frame: Baseline and 24 hours ]
    Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN).

  • Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr) [ Time Frame: Baseline and 24 hours ]
  • Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr) [ Time Frame: Baseline and 24 hours ]
  • Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr) [ Time Frame: Baseline and 24 hours ]

Enrollment: 12
Study Start Date: September 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mg (+)-epicatechin
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
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.
Other Name: Epicatechin
Experimental: 30 mg (+)-epicatechin
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
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.
Other Name: Epicatechin
Experimental: 100 mg (+)-epicatechin
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
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.
Other Name: Epicatechin

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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/m^2
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330276


Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
San Diego Veterans Healthcare System
University of California, San Diego
Investigators
Principal Investigator: Robert R Henry, MD San Diego Veterans Healthcare System
  More Information

Responsible Party: Robert R. Henry, MD, Chief, Section of Diabetes, Endocrinology and Metabolism, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02330276     History of Changes
Other Study ID Numbers: 08847
1R01AT008310-01 ( U.S. NIH Grant/Contract )
First Submitted: December 23, 2014
First Posted: January 1, 2015
Results First Submitted: January 8, 2016
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia