Pre-diabetes
Conditions
Keywords
epicatechin, pre-diabetes
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.
Interventions
DRUGepicatechin
30 mg (+)-epicatechin, taken orally, one pill/day in the morning
DRUGPlacebo
Placebo pill, taken orally, one pill/day in the morning
Sponsors
San Diego Veterans Healthcare System
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Diego
National Institutes of Health (NIH)
Veterans Medical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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: Glucose | Baseline and Day 7 | Change from baseline of glucose (mg/dL) as measured from fasting labs collected at Visits 2 and 3. |
Countries
United States
Outcome results
None listed