Pre-diabetes Clinical Trial
— EpicatechinOfficial title:
(+)-Epicatechin: Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin
Early Phase Pre-Clinical and Initial Clinical Research on (+)- Epicatechin.
Status | Completed |
Enrollment | 12 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 75 Years |
Eligibility |
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/m2 - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA San Diego Healthcare System | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Veterans Medical Research Foundation | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH), San Diego Veterans Healthcare System, University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Levels of Epicatechin and Metabolites | Levels of epicatechin and metabolites present in circulation and urine. | 24 hours | No |
Secondary | Adverse Events | Number of Participants with Adverse Events as a Measure of Safety and Tolerability. | 9 Days | No |
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