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

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
(+)-Epicatechin
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-diabetes

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

10 mg (+)-epicatechin

30 mg (+)-epicatechin

100 mg (+)-epicatechin

Arm Description

4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally

4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally

4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally

Outcomes

Primary Outcome Measures

Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
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
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)
Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)

Full Information

First Posted
December 23, 2014
Last Updated
March 3, 2017
Sponsor
Veterans Medical Research Foundation
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), San Diego Veterans Healthcare System, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02330276
Brief Title
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Acronym
Epicatechin
Official Title
(+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), San Diego Veterans Healthcare System, University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg (+)-epicatechin
Arm Type
Experimental
Arm Description
4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally
Arm Title
30 mg (+)-epicatechin
Arm Type
Experimental
Arm Description
4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally
Arm Title
100 mg (+)-epicatechin
Arm Type
Experimental
Arm Description
4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally
Intervention Type
Drug
Intervention Name(s)
(+)-Epicatechin
Other Intervention Name(s)
Epicatechin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
Description
This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers
Time Frame
Baseline and 24 hours
Secondary Outcome Measure Information:
Title
Change From Baseline in Major Safety Endpoints
Description
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).
Time Frame
Baseline and 24 hours
Title
Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)
Time Frame
Baseline and 24 hours
Title
Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
Time Frame
Baseline and 24 hours
Title
Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)
Time Frame
Baseline and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert R Henry, MD
Organizational Affiliation
San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin

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