Pre-diabetes Clinical Trial
Official title:
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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