Phase 1
N=12
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Pre-diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02330276 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites — 105.8; 132.7; 162.3; 291.3 nM*hr — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- (+)-Epicatechin (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Veterans Medical Research Foundation
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites |
105.8; 132.7; 162.3; 291.3; 1639; 3031 | 0.05 |
| SECONDARY Change From Baseline in Major Safety Endpoints |
0; 0; 0 | <0.05 sig |
| SECONDARY Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr) |
368.3; 342.6; 513.4 | 0.05 |
| SECONDARY Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr) |
1192; 707.2; 1334 | 0.05 |
| SECONDARY Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr) |
61.74; 57.56; 64.23 | 0.05 |
Summary
Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
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
Data sourced from ClinicalTrials.gov (NCT02330276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.