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

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ClinicalTrials.gov Identifier: NCT02656212
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : April 28, 2016
Sponsor:
Collaborators:
San Diego Veterans Healthcare System
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Diego
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Robert R. Henry, MD, Veterans Medical Research Foundation

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pre-diabetes Drug: epicatechin Drug: Placebo Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
Drug Information available for: Cianidanol

Arm Intervention/treatment
Experimental: (+)-epicatechin 30mg
10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin
Drug: epicatechin
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
Other Name: 122158

Placebo Comparator: placebo
5 subjects will be randomized to a placebo
Drug: Placebo
Placebo pill, taken orally, one pill/day in the morning




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02656212


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

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Responsible Party: Robert R. Henry, MD, Chief, Section of Diabetes, Endocrinology and Metabolism, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02656212     History of Changes
Other Study ID Numbers: 08847002
1R01AT008310-01 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Robert R. Henry, MD, Veterans Medical Research Foundation:
epicatechin
pre-diabetes

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