Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
NCT ID: NCT02656212
Last Updated: 2016-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2015-09-30
2016-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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(+)-epicatechin 30mg
10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin
epicatechin
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
placebo
5 subjects will be randomized to a placebo
Placebo
Placebo pill, taken orally, one pill/day in the morning
Interventions
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epicatechin
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
Placebo
Placebo pill, taken orally, one pill/day in the morning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
75 Years
ALL
No
Sponsors
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San Diego Veterans Healthcare System
FED
National Center for Complementary and Integrative Health (NCCIH)
NIH
University of California, San Diego
OTHER
National Institutes of Health (NIH)
NIH
Veterans Medical Research Foundation
OTHER
Responsible Party
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Robert R. Henry, MD
Chief, Section of Diabetes, Endocrinology and Metabolism
Principal Investigators
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Robert R Henry, MD
Role: PRINCIPAL_INVESTIGATOR
San Diego Veterans Healthcare System
Locations
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CMR Center for Metabolic Research VASDHS
San Diego, California, United States
VA San Diego Healthcare System
San Diego, California, United States
Countries
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Other Identifiers
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08847002
Identifier Type: -
Identifier Source: org_study_id
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