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Completed

NCT Number: NCT02656212

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

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

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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

CMR Center for Metabolic Research VASDHS, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

epicatechin

Drug

30 mg (+)-epicatechin, taken orally, one pill/day in the morning

Other names: 122158

Placebo

Drug

Placebo pill, taken orally, one pill/day in the morning

Primary outcomes

  1. Change from baseline in major safety endpoints: Blood Pressure (BP)

    Time frame: Baseline and Day 7

    Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change)

  2. Change from baseline in major safety endpoints: Heart Rate (HR)

    Time frame: Baseline and Day 7

    Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)

  3. Change from baseline in major safety endpoints: Kidney Function

    Time frame: Baseline and Day 7

    Clinically significant differences in the major safety endpoints are defined as: creatinine (>1.5 ULN)

  4. Change from baseline in major safety endpoints: Hepatic Function

    Time frame: Baseline and Day 7

    Clinically significant differences in the major safety endpoints are defined as: highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN)

Secondary outcomes

  1. Change from baseline: Glucose

    Time frame: Baseline and Day 7

    Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3.

  2. Change from baseline: Insulin

    Time frame: Baseline and Day 7

    Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3.

  3. Change from baseline: C-Peptide

    Time frame: Baseline and Day 7

    Change from baseline of C-Peptide (ng/mL) as measured from fasting labs collected at Visits 2 and 3.

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

Acronym: Epicatechin

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 14, 2016
Registry last updated
Apr 28, 2016

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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