Clinical trial NCT02656212: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
Official title: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pre-diabetes
Keywords: epicatechin
pre-diabetes
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: San Diego Veterans Healthcare System
name: National Center for Complementary and Integrative Health (NCCIH)
name: University of California, San Diego
name: National Institutes of Health (NIH)
First posted: 2016-01-14
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in major safety endpoints: Blood Pressure (BP)
timeFrame: Baseline and Day 7
measure: Change from baseline in major safety endpoints: Heart Rate (HR)
timeFrame: Baseline and Day 7
measure: Change from baseline in major safety endpoints: Kidney Function
timeFrame: Baseline and Day 7
measure: Change from baseline in major safety endpoints: Hepatic Function
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: Change from baseline: Glucose
timeFrame: Baseline and Day 7
measure: Change from baseline: Insulin
timeFrame: Baseline and Day 7
measure: Change from baseline: C-Peptide
timeFrame: Baseline and Day 7
Other outcomes:
Locations:
city: San Diego
country: United States
facility: CMR Center for Metabolic Research VASDHS
state: California
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: