Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
- Registration Number
- NCT02656212
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo 5 subjects will be randomized to a placebo (+)-epicatechin 30mg epicatechin 10 subjects will be randomized to a 30mg dose of synthetic (+)-epicatechin
- Primary Outcome Measures
Name Time Method Change from baseline in major safety endpoints: Blood Pressure (BP) Baseline and Day 7 Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change)
Change from baseline in major safety endpoints: Hepatic Function 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)
Change from baseline in major safety endpoints: Heart Rate (HR) Baseline and Day 7 Clinically significant differences in the major safety endpoints are defined as: HR (10 bpm)
Change from baseline in major safety endpoints: Kidney Function Baseline and Day 7 Clinically significant differences in the major safety endpoints are defined as: creatinine (\>1.5 ULN)
- Secondary Outcome Measures
Name Time Method Change from baseline: Glucose Baseline and Day 7 Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3.
Change from baseline: C-Peptide Baseline and Day 7 Change from baseline of C-Peptide (ng/mL) as measured from fasting labs collected at Visits 2 and 3.
Change from baseline: Insulin Baseline and Day 7 Change from baseline of insulin (uIU/ml) as measured from fasting labs collected at Visits 2 and 3.
Trial Locations
- Locations (2)
CMR Center for Metabolic Research VASDHS
🇺🇸San Diego, California, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States