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Completed

NCT Number: NCT02330276

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

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

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Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(+)-Epicatechin

Drug

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 names: Epicatechin

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)

    Time frame: Baseline and 24 hours

  3. Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)

    Time frame: Baseline and 24 hours

  4. Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)

    Time frame: Baseline and 24 hours

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)
  • San Diego Veterans Healthcare System
  • University of California, San Diego

Registry information

Official study title

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

Acronym: Epicatechin

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2015
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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