Clinical trial NCT02330276: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Official title: (+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pre-diabetes
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
name: San Diego Veterans Healthcare System
name: University of California, San Diego
First posted: 2015-01-01
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites
timeFrame: Baseline and 24 hours
Secondary outcomes:
measure: Change From Baseline in Major Safety Endpoints
timeFrame: Baseline and 24 hours
measure: Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)
timeFrame: Baseline and 24 hours
measure: Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)
timeFrame: Baseline and 24 hours
measure: Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)
timeFrame: Baseline and 24 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Robert R Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: